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Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes (onset®7)

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ClinicalTrials.gov Identifier: NCT02670915
Recruitment Status : Completed
First Posted : February 2, 2016
Results First Posted : April 4, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 1
Interventions Drug: Faster-acting insulin aspart
Drug: insulin aspart
Drug: insulin degludec
Enrollment 834
Recruitment Details The trial was conducted at 150 sites in 17 countries(number of sites with screened/randomised subjects)-Bulgaria: 4/4; Czech Republic: 6/6; Estonia: 2/2; Finland: 3/3; Germany: 6/6; India: 7/7; Israel: 6/6; Italy: 5/5; Japan: 34/34; Latvia: 1/1; Lithuania: 1/1; Poland: 4/4; Russia: 11/11; Serbia: 4/4; Turkey: 7/7; Ukraine: 9/9; United States: 40/39
Pre-assignment Details 12-week run-in period: Participants were switched from previous insulin treatment to insulin degludec once daily, and mealtime NovoRapid®/NovoLog®. Insulin degludec treatment was optimised on a weekly basis to the pre-breakfast glycaemic target of 4.0−8.0 mmol/L. Out of 834 participants, who started the run-in period, 57 were run-in failures.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed. Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed. Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Period Title: Overall Study
Started 260 259 258
Completed 256 251 253
Not Completed 4 8 5
Reason Not Completed
Withdrawal by Subject             0             1             4
Withdrawal by parent/guardian             4             4             1
Unclassified             0             3             0
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal) Total
Hide Arm/Group Description Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed. Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed. Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed. Total of all reporting groups
Overall Number of Baseline Participants 260 259 258 777
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 260 participants 259 participants 258 participants 777 participants
11.72  (3.74) 11.62  (3.65) 11.70  (3.44) 11.68  (3.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 259 participants 258 participants 777 participants
Female
126
  48.5%
122
  47.1%
110
  42.6%
358
  46.1%
Male
134
  51.5%
137
  52.9%
148
  57.4%
419
  53.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 259 participants 258 participants 777 participants
Hispanic or Latino
16
   6.2%
17
   6.6%
12
   4.7%
45
   5.8%
Not Hispanic or Latino
244
  93.8%
242
  93.4%
246
  95.3%
732
  94.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 259 participants 258 participants 777 participants
American Indian or Alaska Native
0
   0.0%
1
   0.4%
1
   0.4%
2
   0.3%
Asian
46
  17.7%
37
  14.3%
43
  16.7%
126
  16.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   2.3%
4
   1.5%
5
   1.9%
15
   1.9%
White
206
  79.2%
217
  83.8%
209
  81.0%
632
  81.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   0.8%
0
   0.0%
0
   0.0%
2
   0.3%
1.Primary Outcome
Title Change in the Percentage of HbA1c
Hide Description Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related participant-site contact and included data collected after a subject discontinued trial product.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), which included all randomised participants. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c
Baseline Number Analyzed 260 participants 259 participants 258 participants
7.57  (0.80) 7.58  (0.84) 7.53  (0.83)
Change from baseline Number Analyzed 259 participants 259 participants 258 participants
0.06  (0.80) 0.33  (0.83) 0.23  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faster Aspart (Meal), NovoRapid (Meal)
Comments The primary analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value (s) imputed from the available information from the treatment the participant had been randomised to.
Type of Statistical Test Non-Inferiority
Comments Stepwise hierarchical testing procedure was applied: Step 1-Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% confidence interval (CI) was below or equal to 0.4%.
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.
Method Multiple imputation
Comments Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.30 to -0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Faster Aspart (Post), NovoRapid (Meal)
Comments The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.
Type of Statistical Test Non-Inferiority
Comments Stepwise hierarchical testing procedure was applied: Step 2-Confirmatory secondary analysis: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%.
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.
Method Multiple imputation
Comments Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.01 to 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Faster Aspart (Meal), NovoRapid (Meal)
Comments The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.
Type of Statistical Test Superiority
Comments Stepwise hierarchical testing procedure was applied: Step 3-Confirmatory secondary analysis: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Superiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below 0.
Statistical Test of Hypothesis P-Value =0.007
Comments p-values are from the 1-sided test for superiority evaluated at the 2.5% level.
Method multiple imputation
Comments Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.30 to -0.03
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in 8-point SMPG Profile: Mean PPG Over All Three Meals
Hide Description Change from baseline (week 0) in mean post prandial glucose (PPG) over all three meals was evaluated after 26 weeks of randomisation. PPG for each meal (breakfast, lunch and main evening meal) was recorded by the participant as part of the 8-point self-measured plasma glucose (SMPG) profile. Mean PPG over all three meals was derived as the mean of all corresponding mean meal. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 210 participants 221 participants 214 participants
10.19  (2.64) 10.12  (2.79) 10.03  (2.52)
Change from baseline Number Analyzed 196 participants 200 participants 203 participants
-0.94  (2.55) 0.36  (3.17) -0.21  (2.79)
3.Secondary Outcome
Title Change in 8-point SMPG Profile: PPG Increment Over All Three Meals
Hide Description Change from baseline (week 0) in mean PPG increment over all three meals was evaluated after 26 weeks of randomisation. Postprandial glucose (PPG) increment for each meal (breakfast, lunch and main evening meal) was derived from the 8-point profile as the difference between PPG (1 hour after the meal) values and the plasma glucose (PG) value before meal. The mean of the derived increments was then calculated separately for each meal. Mean PPG increment over all three meals was derived as the mean of all corresponding mean meal increments. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis. .
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 210 participants 219 participants 213 participants
1.20  (2.70) 1.01  (2.48) 0.97  (2.55)
Change from baseline Number Analyzed 196 participants 197 participants 202 participants
-0.92  (2.92) 0.56  (2.88) 0.14  (2.75)
4.Secondary Outcome
Title Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG
Hide Description Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG was evaluated after 26 weeks of randomisation. PPG for each meal was recorded by the participant as part of the 8-point SMPG profile. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Breakfast: Baseline Number Analyzed 227 participants 235 participants 236 participants
10.51  (3.59) 10.51  (3.77) 10.49  (3.59)
Breakfast: Change from baseline Number Analyzed 216 participants 217 participants 229 participants
-1.11  (3.91) 0.16  (3.95) 0.04  (3.89)
Lunch: Baseline Number Analyzed 227 participants 232 participants 229 participants
9.69  (3.32) 9.99  (3.82) 9.62  (3.30)
Lunch: Change from baseline Number Analyzed 215 participants 220 participants 223 participants
-0.80  (3.74) 0.18  (4.40) -0.24  (4.22)
Main evening meal: Baseline Number Analyzed 228 participants 231 participants 231 participants
10.24  (3.64) 9.90  (3.59) 9.87  (3.46)
Main evening meal: Change from baseline Number Analyzed 222 participants 220 participants 225 participants
-0.74  (3.96) 0.61  (4.40) -0.05  (4.14)
5.Secondary Outcome
Title Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment
Hide Description Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG increment was evaluated after 26 weeks of randomisation. PPG increment for each meal was derived from the 8-point profile as the difference between PPG values (1 hour after the meal) and the PG value before meal. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Breakfast: Baseline Number Analyzed 227 participants 235 participants 235 participants
1.90  (3.64) 2.10  (3.59) 2.12  (4.08)
Breakfast: Change from baseline Number Analyzed 216 participants 217 participants 228 participants
-0.82  (4.44) 0.46  (4.21) 0.10  (4.66)
Lunch: Baseline Number Analyzed 227 participants 231 participants 229 participants
1.02  (3.82) 1.12  (3.79) 0.74  (3.88)
Lunch: Change from baseline Number Analyzed 215 participants 219 participants 222 participants
-0.58  (4.92) 0.12  (4.41) -0.11  (4.54)
Main evening meal: Baseline Number Analyzed 228 participants 230 participants 231 participants
0.53  (4.28) -0.26  (3.53) -0.06  (3.78)
Main evening meal: Change from baseline Number Analyzed 222 participants 218 participants 225 participants
-0.92  (5.07) 1.03  (4.68) 0.45  (4.31)
6.Secondary Outcome
Title Change in 8-point SMPG Profile: Mean of the 8-point Profile
Hide Description Change from baseline (week 0) in mean of the 8-point SMPG profile was evaluated after 26 weeks of randomisation. SMPG values were recorded at 8 time-points on two consecutive days: before and after (60 minute after the start of the meal) breakfast, lunch and main evening meal, before bedtime, and before breakfast on the next day. Mean of the 8-point profile was derived as the mean of all corresponding mean SMPG recorded at 8 different time points. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 240 participants 242 participants 246 participants
9.41  (1.98) 9.47  (1.89) 9.39  (1.97)
Change from baseline Number Analyzed 235 participants 235 participants 245 participants
-0.27  (2.04) 0.17  (2.12) -0.05  (2.29)
7.Secondary Outcome
Title Fluctuation in the 8-point SMPG Profile
Hide Description Fluctuation in the 8-point SMPG profile was evaluated after 26 weeks of randomisation. Fluctuation in 8-point SMPG profile was the average absolute difference from the mean of the SMPG profile. The results are based on the last in-trial value.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mmol/L
1.88
(44.49%)
1.94
(42.51%)
1.83
(45.98%)
8.Secondary Outcome
Title Change in FPG
Hide Description Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 186 participants 198 participants 180 participants
7.58  (3.56) 8.03  (3.35) 7.79  (3.48)
Change from baseline Number Analyzed 173 participants 185 participants 161 participants
0.41  (5.04) -0.08  (4.49) -0.13  (4.16)
9.Secondary Outcome
Title Change in 1,5-anhydroglucitol
Hide Description Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: ug/mL
Baseline Number Analyzed 258 participants 257 participants 254 participants
4.95  (3.62) 5.07  (3.97) 5.13  (3.76)
Change from baseline Number Analyzed 257 participants 257 participants 254 participants
-0.06  (3.13) -0.85  (2.80) -0.63  (2.42)
10.Secondary Outcome
Title Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines
Hide Description Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Percentage of participants
Yes 42.3 31.7 39.5
No 57.7 68.3 60.5
11.Secondary Outcome
Title Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia
Hide Description Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to ISPAD guidelines, without severe hypoglycaemia was evaluated after 26 weeks of randomisation. Severe hypoglycaemia according to ISPAD guidelines: hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose). The results are based on the last in-trial value.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Percentage of participants
Yes 41.9 30.9 38.4
No 58.1 69.1 61.6
12.Secondary Outcome
Title Insulin Dose (Units/Day): Total Basal
Hide Description Total basal insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised NovoRapid®/NovoLog® / faster aspart and no later than 7 days after the day of last dose of NovoRapid®/NovoLog® / faster aspart. The on-treatment observation period includes data collected up to and including 7 days after treatment discontinuation. Number of participants analysed = number of participants contributed to the analysis. Analysis population description: Safety analysis set (SAS) included all participants receiving at least one dose of the investigational product (faster aspart) or its comparator (NovoRapid®/NovoLog®).
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Units (U)
21.6  (12.9) 21.5  (14.5) 20.7  (12.8)
13.Secondary Outcome
Title Insulin Dose (Units/Day): Total Bolus
Hide Description Total bolus insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Units (U)
23.3  (14.5) 23.5  (15.1) 22.5  (13.0)
14.Secondary Outcome
Title Insulin Dose (Units/Day): Individual Meal Insulin Dose
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Units (U)
Breakfast 7.3  (5.1) 7.1  (4.9) 6.8  (4.4)
Lunch 8.1  (5.1) 8.4  (6.2) 7.9  (5.2)
Main evening meal 8.1  (6.0) 8.0  (5.4) 7.7  (5.1)
15.Secondary Outcome
Title Insulin Dose (Units/kg/Day): Total Basal
Hide Description Total basal insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Units (U)/kg
0.433  (0.228) 0.425  (0.196) 0.409  (0.176)
16.Secondary Outcome
Title Insulin Dose (Units/kg/Day): Total Bolus
Hide Description Total bolus insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Units (U)/kg
0.483  (0.256) 0.491  (0.241) 0.468  (0.224)
17.Secondary Outcome
Title Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Units (U)/kg
Breakfast 0.151  (0.091) 0.150  (0.079) 0.144  (0.081)
Lunch 0.170  (0.103) 0.174  (0.104) 0.166  (0.095)
Main evening meal 0.164  (0.099) 0.165  (0.092) 0.158  (0.086)
18.Secondary Outcome
Title Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL])
Hide Description Change from baseline (week 0) in the time spent in low IG (<=3.9 mmol/L [70 mg/dL]) based on continuous glucose monitoring (CGM) was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Minutes/day
Baseline Number Analyzed 43 participants 48 participants 44 participants
107.94  (77.34) 100.70  (77.28) 81.52  (71.90)
Change from baseline Number Analyzed 42 participants 46 participants 41 participants
-24.11  (71.74) -13.06  (82.55) 6.92  (74.64)
19.Secondary Outcome
Title Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)
Hide Description Incidence of episodes (number of episodes per 24 hours) with IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was calculated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes per 24 hours
Episodes with IG <=2.5 mmol/L Number Analyzed 36 participants 36 participants 32 participants
0.55 0.68 0.57
Episodes with IG <=3.0 mmol/L Number Analyzed 39 participants 42 participants 36 participants
1.01 1.10 1.03
Episodes with IG <=3.9 mmol/L Number Analyzed 42 participants 45 participants 39 participants
2.29 2.30 2.24
Episodes with IG >10 mmol/L Number Analyzed 42 participants 46 participants 41 participants
11.52 11.61 11.65
Episodes with IG >12 mmol/L Number Analyzed 42 participants 46 participants 41 participants
7.64 7.77 8.05
20.Secondary Outcome
Title Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)
Hide Description Percentage of time spent with IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Percentage of time
Time spent with IG <=2.5 mmol/L Number Analyzed 42 participants 46 participants 41 participants
1.09  (1.50) 1.80  (3.21) 1.34  (1.90)
Time spent with IG <=3.0 mmol/L Number Analyzed 42 participants 46 participants 41 participants
2.19  (2.35) 2.90  (4.06) 2.48  (2.92)
Time spent with IG <=3.9 mmol/L Number Analyzed 42 participants 46 participants 41 participants
5.97  (4.59) 6.25  (5.68) 5.97  (5.38)
Time spent with IG >10 mmol/L Number Analyzed 42 participants 46 participants 41 participants
40.40  (14.80) 40.60  (14.38) 42.47  (17.51)
Time spent with IG >12 mmol/L Number Analyzed 42 participants 46 participants 41 participants
26.09  (12.82) 25.67  (13.60) 28.62  (16.83)
21.Secondary Outcome
Title Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included
Hide Description Percentage of time spent within IG target 4.0-10.0 mmol/L (71-180 mg/dL), both included based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Percentage of time
53.00  (12.15) 52.56  (14.08) 51.03  (16.25)
22.Secondary Outcome
Title Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal)
Hide Description Change from baseline (week 0) in mean IG increment (0-1 hours and 0-2 hours after start of the meal) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
0-1 hour: Baseline Number Analyzed 37 participants 45 participants 41 participants
0.56  (0.58) 0.73  (0.54) 0.61  (0.49)
0-1 hour: Change from baseline Number Analyzed 36 participants 41 participants 40 participants
-0.19  (0.55) 0.26  (0.83) 0.07  (0.50)
0-2 hour: Baseline Number Analyzed 37 participants 45 participants 41 participants
0.76  (0.75) 1.10  (1.03) 0.86  (0.69)
0-2 hour: Change from baseline Number Analyzed 36 participants 41 participants 40 participants
-0.35  (0.87) 0.55  (1.14) 0.09  (0.59)
23.Secondary Outcome
Title Change in Mean IG Peak After Start of Meal
Hide Description Change from baseline (week 0) in mean IG peak after start of meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 37 participants 45 participants 41 participants
12.90  (1.88) 12.92  (1.97) 12.90  (2.25)
Change from baseline Number Analyzed 37 participants 42 participants 40 participants
-0.28  (1.91) 0.80  (1.84) 0.38  (2.00)
24.Secondary Outcome
Title Change in Mean Time to the IG Peak After Meal
Hide Description Change from baseline (week 0) in mean time to the IG peak after meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of subjects wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Minutes
Baseline Number Analyzed 37 participants 45 participants 41 participants
103.16  (16.87) 106.21  (20.68) 102.20  (17.09)
Change from baseline Number Analyzed 37 participants 42 participants 40 participants
4.70  (25.85) -8.56  (22.62) 2.29  (19.80)
25.Secondary Outcome
Title Change in 30-minute PPG
Hide Description Change from baseline (week 0) in 30-minute PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 30-minute after the meal intake at the visit. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 41 participants 46 participants 40 participants
11.28  (3.26) 10.96  (3.78) 11.71  (3.13)
Change from baseline Number Analyzed 40 participants 45 participants 39 participants
-0.21  (3.49) 1.84  (3.41) -0.45  (3.42)
26.Secondary Outcome
Title Change in 30-minute PPG Increment
Hide Description Change from baseline (week 0) in 30-minute PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 30-minute (after the meal) at the visit. PPG increment was derived as 30-minute PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 41 participants 46 participants 40 participants
3.44  (2.16) 3.48  (2.50) 4.02  (2.18)
Change from baseline Number Analyzed 40 participants 44 participants 39 participants
0.36  (2.92) 1.92  (2.79) -0.34  (2.18)
27.Secondary Outcome
Title Change in 1-hour PPG
Hide Description Change from baseline (week 0) in 1-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 1-hour after the meal intake at the visit. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 41 participants 46 participants 40 participants
12.77  (3.92) 12.56  (5.08) 13.06  (3.86)
Change from baseline Number Analyzed 40 participants 45 participants 39 participants
-0.15  (4.39) 2.54  (4.43) -0.63  (4.73)
28.Secondary Outcome
Title Change in 1-hour PPG Increment
Hide Description Change from baseline (week 0) in 1-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 1-hour (after the meal) at the visit. PPG increment was derived as 1-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 41 participants 46 participants 40 participants
4.93  (3.34) 5.08  (4.21) 5.36  (2.77)
Change from baseline Number Analyzed 40 participants 44 participants 39 participants
0.42  (4.93) 2.63  (4.03) -0.52  (3.17)
29.Secondary Outcome
Title Change in 2-hour PPG
Hide Description Change from baseline (week 0) in 2-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 2-hour after the meal intake at the visit. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 41 participants 46 participants 40 participants
12.50  (4.63) 12.54  (5.74) 12.37  (4.74)
Change from baseline Number Analyzed 40 participants 45 participants 39 participants
0.69  (5.88) 1.80  (5.08) -0.75  (5.64)
30.Secondary Outcome
Title Change in 2-hour PPG Increment
Hide Description Change from baseline (week 0) in 2-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 2-hour (after the meal) at the visit. PPG increment was derived as 2-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 41 participants 46 participants 40 participants
4.66  (4.22) 5.06  (5.04) 4.67  (3.83)
Change from baseline Number Analyzed 40 participants 44 participants 39 participants
1.26  (6.81) 1.62  (5.03) -0.64  (4.43)
31.Secondary Outcome
Title Change in AUCIG,0-15min
Hide Description Change in area under the IG curve 0-15 minutes post meal (AUCIG,0-15min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. Interstitial glucose (IG) was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 37 participants 43 participants 40 participants
8.01  (2.72) 7.49  (2.07) 7.66  (1.96)
Change from baseline Number Analyzed 34 participants 41 participants 38 participants
-1.27  (3.68) 0.08  (2.48) -0.53  (2.85)
32.Secondary Outcome
Title Change in AUCIG,0-30min
Hide Description Change in area under the IG curve 0-30 minutes post meal (AUCIG,0-30min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 37 participants 43 participants 40 participants
8.28  (2.75) 7.80  (2.13) 8.13  (1.87)
Change from baseline Number Analyzed 34 participants 41 participants 38 participants
-1.15  (3.62) 0.22  (2.52) -0.47  (2.81)
33.Secondary Outcome
Title Change in AUCIG,0-1h
Hide Description Change in area under the IG curve 0-1 hour post meal (AUCIG,0-1h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 37 participants 44 participants 40 participants
9.63  (2.90) 9.43  (2.71) 10.02  (2.19)
Change from baseline Number Analyzed 34 participants 42 participants 38 participants
-0.87  (3.71) 0.54  (3.00) -0.65  (2.91)
34.Secondary Outcome
Title Change in AUCIG,0-2h
Hide Description Change in area under the IG curve 0-2 hours post meal (AUCIG,0-2h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 38 participants 44 participants 40 participants
11.40  (3.20) 11.48  (3.43) 11.76  (2.80)
Change from baseline Number Analyzed 35 participants 42 participants 38 participants
-0.84  (3.93) 0.75  (3.74) -0.86  (3.61)
35.Secondary Outcome
Title Change in AUCIG,0-4h
Hide Description Change in area under the IG curve 0-4 hours post meal (AUCIG,0-4h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 38 participants 44 participants 40 participants
11.21  (3.25) 11.19  (3.47) 11.46  (3.21)
Change from baseline Number Analyzed 35 participants 42 participants 38 participants
-0.38  (3.96) 0.62  (3.97) -1.30  (4.13)
36.Secondary Outcome
Title Change in Time to the IG Peak After Start of Meal
Hide Description Change in time to the IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Minute
Baseline Number Analyzed 38 participants 44 participants 40 participants
102.85  (48.93) 94.26  (38.22) 93.80  (39.19)
Change from baseline Number Analyzed 35 participants 42 participants 38 participants
5.29  (55.42) -0.04  (42.05) -8.76  (52.17)
37.Secondary Outcome
Title Change in IG Peak After Start of Meal
Hide Description Change in IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analysed = number of participants contributed to the analysis.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline Number Analyzed 38 participants 44 participants 40 participants
14.87  (3.55) 15.15  (4.52) 15.11  (3.62)
Change from baseline Number Analyzed 35 participants 42 participants 38 participants
-0.55  (3.77) 1.11  (4.88) -1.36  (4.36)
38.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total
Hide Description Treatment emergent: if the onset of the episode occurred on or after the first day of treatment with investigational medicinal product (IMP) after randomisation, and no later than 1 day after the last day on IMP. Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic: episode during which typical symptoms of hypoglycaemia are accompanied by a PG level ≤3.9 mmol/L. 3) Asymptomatic: episode not accompanied by typical symptoms of hypoglycaemia, but with a PG level ≤3.9 mmol/L. 4) Probable symptomatic: an episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG level ≤3.9 mmol/L. 5) Pseudo-hypoglycaemia: episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a PG level >3.9mmol/L, but approaching that level. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 3 8 4
Documented symptomatic 5391 5712 5170
Asymptomatic 4255 3781 3656
Probable symptomatic 12 10 24
Pseudo-hypoglycaemia 35 37 47
Unclassifiable 5 2 1
39.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 3 5 3
Documented symptomatic 4895 5077 4779
Asymptomatic 3584 3163 3101
Probable symptomatic 10 10 22
Pseudo-hypoglycaemia 32 31 42
Unclassifiable 5 2 1
40.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 0 3 1
Documented symptomatic 496 635 391
Asymptomatic 671 618 555
Probable symptomatic 2 0 2
Pseudo-hypoglycaemia 3 6 5
Unclassifiable 0 0 0
41.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) Symptomatic blood glucose (BG) confirmed: episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3) Asymptomatic BG confirmed: episode that is BG confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG confirmed symptomatic: an episode that is severe according to the ISPAD classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG confirmed: an episode that is BG confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG confirmed: an episode that is severe according to the ISPAD Classification or BG confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 3 8 4
BG confirmed 3580 3586 3272
Severe or BG confirmed symptomatic 2242 2427 2194
Severe or BG confirmed 3583 3594 3276
Unclassifiable 6118 5956 5626
42.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 3 5 3
BG confirmed 3184 3112 2960
Severe or BG confirmed symptomatic 2062 2167 2035
Severe or BG confirmed 3187 3117 2963
Unclassifiable 5342 5171 4985
43.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 0 3 1
BG confirmed 396 474 312
Severe or BG confirmed symptomatic 180 260 159
Severe or BG confirmed 396 477 313
Unclassifiable 776 785 641
44.Secondary Outcome
Title Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 0 0 0
Documented symptomatic 178 113 157
Asymptomatic 77 51 55
Probable symptomatic 0 0 1
Pseudo-hypoglycaemia 1 2 1
Unclassifiable 0 0 0
45.Secondary Outcome
Title Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 2 1 1
Documented symptomatic 1125 882 1016
Asymptomatic 421 268 303
Probable symptomatic 1 1 7
Pseudo-hypoglycaemia 6 6 4
Unclassifiable 0 0 0
46.Secondary Outcome
Title Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 3 1 2
Documented symptomatic 3041 3064 2812
Asymptomatic 1340 1194 1168
Probable symptomatic 4 8 16
Pseudo-hypoglycaemia 15 18 17
Unclassifiable 2 0 0
47.Secondary Outcome
Title Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 1 0 1
Documented symptomatic 1916 2182 1796
Asymptomatic 919 926 865
Probable symptomatic 3 7 9
Pseudo-hypoglycaemia 9 12 13
Unclassifiable 2 0 0
48.Secondary Outcome
Title Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 0 0 0
BG confirmed 119 66 105
Severe or BG confirmed symptomatic 94 49 85
Severe or BG confirmed 119 66 105
Unclassifiable 137 100 109
49.Secondary Outcome
Title Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 2 1 1
BG confirmed 715 504 600
Severe or BG confirmed symptomatic 572 414 495
Severe or BG confirmed 717 505 601
Unclassifiable 838 653 730
50.Secondary Outcome
Title Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 3 1 2
BG confirmed 1774 1781 1666
Severe or BG confirmed symptomatic 1365 1375 1277
Severe or BG confirmed 1777 1782 1668
Unclassifiable 2628 2503 2347
51.Secondary Outcome
Title Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Hide Description Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Episodes
Severe 1 0 1
BG confirmed 1059 1277 1066
Severe or BG confirmed symptomatic 793 961 782
Severe or BG confirmed 1060 1277 1067
Unclassifiable 1790 1850 1617
52.Secondary Outcome
Title Number of Treatment Emergent Adverse Events (AEs)
Hide Description Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP (faster aspart or NovoRapid®/NovoLog®) and excluding the events occurring in the run-in period. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Events
576 678 593
53.Secondary Outcome
Title Number of Treatment Emergent Injection Site Reactions
Hide Description Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP and excluding the events occurring in the run-in period. The results are based on the on-treatment period.
Time Frame Week 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Events
11 31 17
54.Secondary Outcome
Title Change in Physical Examination
Hide Description The following physical examinations were done: 1) Cardiovascular system. 2) Central and peripheral nervous system. 3) Gastrointestinal system including the mouth. 4) General appearance. 5) Head, ears, eyes, nose, throat and neck. 6) Musculoskeletal system. 7) Respiratory system. 8) Skin. Presented results are number of participants with the following outcomes: normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS). Presented results are baseline (week 0) and last on-treatment values. Number of participants analysed = number of participants contributed to the analysis.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Measure Type: Number
Unit of Measure: Participants
1) Baseline: Normal Number Analyzed 260 participants 259 participants 258 participants
260 254 258
1) Baseline: Abnormal, NCS Number Analyzed 260 participants 259 participants 258 participants
1 4 0
1) Baseline: Abnormal, CS Number Analyzed 260 participants 259 participants 258 participants
0 0 0
1) Last on-treatment: Normal Number Analyzed 257 participants 258 participants 257 participants
257 253 257
1) Last on-treatment: Abnormal, NCS Number Analyzed 257 participants 258 participants 257 participants
0 5 0
1) Last on-treatment: Abnormal, CS Number Analyzed 257 participants 258 participants 257 participants
0 0 0
2) Baseline: Normal Number Analyzed 260 participants 259 participants 258 participants
257 253 258
2) Baseline: Abnormal, NCS Number Analyzed 260 participants 259 participants 258 participants
3 4 0
2) Baseline: Abnormal, CS Number Analyzed 260 participants 259 participants 258 participants
1 1 0
2) Last on-treatment: Normal Number Analyzed 257 participants 258 participants 257 participants
255 253 257
2) Last on-treatment: Abnormal, NCS Number Analyzed 257 participants 258 participants 257 participants
2 4 0
2) Last on-treatment: Abnormal, CS Number Analyzed 257 participants 258 participants 257 participants
0 1 0
3) Baseline: Normal Number Analyzed 260 participants 259 participants 258 participants
258 257 254
3) Baseline: Abnormal, NCS Number Analyzed 260 participants 259 participants 258 participants
3 1 3
3) Baseline: Abnormal, CS Number Analyzed 260 participants 259 participants 258 participants
0 0 1
3) Last on-treatment: Normal Number Analyzed 257 participants 258 participants 257 participants
253 257 256
3) Last on-treatment: Abnormal, NCS Number Analyzed 257 participants 258 participants 257 participants
4 1 0
3) Last on-treatment: Abnormal, CS Number Analyzed 257 participants 258 participants 257 participants
0 0 1
4) Baseline: Normal Number Analyzed 260 participants 259 participants 258 participants
258 253 254
4) Baseline: Abnormal, NCS Number Analyzed 260 participants 259 participants 258 participants
2 3 4
4) Baseline: Abnormal, CS Number Analyzed 260 participants 259 participants 258 participants
1 2 0
4) Last on-treatment: Normal Number Analyzed 257 participants 258 participants 257 participants
257 253 254
4) Last on-treatment: Abnormal, NCS Number Analyzed 257 participants 258 participants 257 participants
0 4 3
4) Last on-treatment: Abnormal, CS Number Analyzed 257 participants 258 participants 257 participants
0 1 0
5) Baseline: Normal Number Analyzed 260 participants 259 participants 258 participants
251 238 245
5) Baseline: Abnormal, NCS Number Analyzed 260 participants 259 participants 258 participants
9 13 11
5) Baseline: Abnormal, CS Number Analyzed 260 participants 259 participants 258 participants
1 7 2
5) Last on-treatment: Normal Number Analyzed 257 participants 258 participants 257 participants
247 244 242
5) Last on-treatment: Abnormal, NCS Number Analyzed 257 participants 258 participants 257 participants
7 11 14
5) Last on-treatment: Abnormal, CS Number Analyzed 257 participants 258 participants 257 participants
3 3 1
6) Baseline: Normal Number Analyzed 260 participants 259 participants 258 participants
259 252 254
6) Baseline: Abnormal, NCS Number Analyzed 260 participants 259 participants 258 participants
2 4 3
6) Baseline: Abnormal, CS Number Analyzed 260 participants 259 participants 258 participants
0 2 1
6) Last on-treatment: Normal Number Analyzed 257 participants 258 participants 257 participants
254 253 253
6) Last on-treatment: Abnormal, NCS Number Analyzed 257 participants 258 participants 257 participants
1 3 3
6) Last on-treatment: Abnormal, CS Number Analyzed 257 participants 258 participants 257 participants
2 2 1
7) Baseline: Normal Number Analyzed 260 participants 259 participants 258 participants
259 256 256
7) Baseline: Abnormal, NCS Number Analyzed 260 participants 259 participants 258 participants
1 2 1
7) Baseline: Abnormal, CS Number Analyzed 260 participants 259 participants 258 participants
1 0 1
7) Last on-treatment: Normal Number Analyzed 257 participants 258 participants 257 participants
257 258 257
7) Last on-treatment: Abnormal, NCS Number Analyzed 257 participants 258 participants 257 participants
0 0 0
7) Last on-treatment: Abnormal, CS Number Analyzed 257 participants 258 participants 257 participants
0 0 0
8) Baseline: Normal Number Analyzed 260 participants 259 participants 258 participants
239 237 238
8) Baseline: Abnormal, NCS Number Analyzed 260 participants 259 participants 258 participants
18 21 16
8) Baseline: Abnormal, CS Number Analyzed 260 participants 259 participants 258 participants
4 0 4
8) Last on-treatment: Normal Number Analyzed 257 participants 258 participants 257 participants
229 233 235
8) Last on-treatment: Abnormal, NCS Number Analyzed 257 participants 258 participants 257 participants
19 22 17
8) Last on-treatment: Abnormal, CS Number Analyzed 257 participants 258 participants 257 participants
9 3 5
55.Secondary Outcome
Title Change in Vital Sign: Blood Pressure
Hide Description Change from baseline (week 0) in blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP: Baseline 106.4  (11.8) 107.0  (12.6) 106.8  (11.4)
SBP: Change from baseline 0.8  (11.0) 1.5  (10.4) 1.1  (10.1)
DBP: Baseline 65.4  (8.3) 65.7  (9.4) 65.4  (7.9)
DBP: Change from baseline 1.2  (9.1) 1.4  (9.3) 1.4  (8.3)
56.Secondary Outcome
Title Change in Vital Sign: Pulse
Hide Description Change from baseline (week 0) in pulse was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Beats/minute
Baseline 80.6  (11.8) 80.5  (11.8) 79.4  (11.8)
Change from baseline -0.6  (10.3) 0.3  (10.8) 0.7  (11.0)
57.Secondary Outcome
Title Change in Body Weight
Hide Description Change from baseline (week 0) in body weight was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: kg
Baseline Number Analyzed 260 participants 259 participants 258 participants
46.69  (18.15) 46.48  (18.98) 46.28  (17.18)
Change from baseline Number Analyzed 257 participants 258 participants 257 participants
2.21  (2.57) 1.90  (2.32) 2.15  (2.80)
58.Secondary Outcome
Title Change in Height
Hide Description Change from baseline (week 0) in height was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Meter
Baseline Number Analyzed 260 participants 259 participants 258 participants
1.50  (0.21) 1.50  (0.21) 1.50  (0.19)
Change from baseline Number Analyzed 257 participants 258 participants 257 participants
0.02  (0.02) 0.02  (0.02) 0.02  (0.02)
59.Secondary Outcome
Title Change in Body Mass Index
Hide Description Change from baseline (week 0) in body mass index (BMI) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Baseline Number Analyzed 260 participants 258 participants 258 participants
19.68  (3.75) 19.67  (4.02) 19.64  (3.78)
Change from baseline Number Analyzed 257 participants 258 participants 257 participants
0.37  (0.92) 0.28  (0.92) 0.34  (1.10)
60.Secondary Outcome
Title Change in SD Score of Body Weight
Hide Description Change from baseline (week 0) in standard deviation (SD) score of body weight was evaluated after 26 weeks of randomisation. SD-scores are defined to be able to normalise the body weight in the various age groups. To estimate the growth of children, standardised weight is calculated for each year of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2. The SD scores are derived from the age and sex of the subjects and the body weight together with growth curves defined for a reference population. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Standard deviation score
Baseline Number Analyzed 260 participants 258 participants 258 participants
0.349  (0.945) 0.351  (0.936) 0.361  (0.875)
Change from baseline Number Analyzed 257 participants 258 participants 257 participants
0.034  (0.231) 0.008  (0.223) 0.030  (0.250)
61.Secondary Outcome
Title Change in SD Score of Body Mass Index
Hide Description Change from baseline (week 0) in SD score of BMI was evaluated after 26 weeks of randomisation. SD scores for BMI were determined in a similar way as SD scores for weight by use of a suitable reference population based on age and sex. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Hide Arm/Group Description:
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0−8.0 mmol/L, and the bed-time target of 6.7–10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed.
Overall Number of Participants Analyzed 260 259 258
Mean (Standard Deviation)
Unit of Measure: Standard deviation score
Baseline Number Analyzed 260 participants 258 participants 258 participants
0.296  (0.895) 0.298  (0.936) 0.317  (0.898)