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Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes (onset®8)

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ClinicalTrials.gov Identifier: NCT02500706
Recruitment Status : Completed
First Posted : July 16, 2015
Results First Posted : August 10, 2018
Last Update Posted : June 12, 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 1108
Recruitment Details The trial was conducted at 146 sites in 12 countries(number of sites indicates those that both screened and randomised subjects, unless otherwise noted)-Austria(4);Bulgaria(8); Canada(6); Germany(7); India(16); Israel(6); Italy(4); Japan(24); Russian Federation(10); Serbia(3); Taiwan(3); United States(55 sites screened/52 sites randomised subjects)
Pre-assignment Details Eligible subjects were enrolled in a 8-week run-in period (1108 subjects) where subjects were switched from previous insulin treatment to insulin degludec once daily,and NovoRapid®/NovoLog® as mealtime bolus insulin. The basal insulin treatment was optimised using treat-to-target approach. 83 subjects were run-in failures and 1025 were randomised.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Period Title: Overall Study
Started 342 341 342
Exposed 342 341 342
Completed 338 334 335
Not Completed 4 7 7
Reason Not Completed
Adverse Event             0             0             1
Lost to Follow-up             0             1             1
Withdrawal by Subject             4             6             4
Unclassified             0             0             1
Arm/Group Title Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal) Total
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Total of all reporting groups
Overall Number of Baseline Participants 342 341 342 1025
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all randomised subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 342 participants 341 participants 342 participants 1025 participants
41.48  (14.42) 41.02  (14.59) 40.77  (14.22) 41.09  (14.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 342 participants 341 participants 342 participants 1025 participants
Female
158
  46.2%
155
  45.5%
163
  47.7%
476
  46.4%
Male
184
  53.8%
186
  54.5%
179
  52.3%
549
  53.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 342 participants 341 participants 342 participants 1025 participants
Hispanic or Latino
13
   3.8%
8
   2.3%
12
   3.5%
33
   3.2%
Not Hispanic or Latino
329
  96.2%
333
  97.7%
330
  96.5%
992
  96.8%
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 342 participants 341 participants 342 participants 1025 participants
American Indian or Alaska Native
1
   0.3%
0
   0.0%
1
   0.3%
2
   0.2%
Asian
116
  33.9%
131
  38.4%
137
  40.1%
384
  37.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   1.8%
4
   1.2%
6
   1.8%
16
   1.6%
White
219
  64.0%
206
  60.4%
198
  57.9%
623
  60.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glycosylated hemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of HbA1c
Number Analyzed 342 participants 341 participants 342 participants 1025 participants
7.46  (0.68) 7.40  (0.60) 7.41  (0.79) 7.42  (0.70)
1.Primary Outcome
Title Change From Baseline in HbA1c 26 Weeks After Randomisation
Hide Description Change from baseline (week 0) in 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 subject-site contact.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 341
Mean (Standard Deviation)
Unit of Measure: percentage of HbA1c
-0.12  (0.64) 0.005  (0.64) -0.09  (0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faster Aspart (Meal), NovoRapid (Meal)
Comments The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.
Type of Statistical Test Non-Inferiority
Comments

Stepwise hierarchical testing procedure was applied for confirmatory endpoints:

Step 1: Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.

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-value from the 2-sided test for treatment difference evaluated at the 5% level
Method ANOVA model after multiple imputation
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.11 to 0.07
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 endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.
Type of Statistical Test Non-Inferiority
Comments

Stepwise hierarchical testing procedure was applied for confirmatory endpoints:

Step 2: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog®.

Non-inferiority of postmeal 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-value from the 2-sided test for treatment difference evaluated at the 5% level.
Method ANOVA model after multiple imputation
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.004 to 0.19
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 endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.
Type of Statistical Test Superiority
Comments

Stepwise hierarchical testing procedure was applied for confirmatory endpoints:

Step 4: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.

Superiority was to be confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0%-points.

Statistical Test of Hypothesis P-Value 0.633
Comments p-value from the 2-sided test for treatment difference evaluated at the 5% level
Method ANOVA model after multiple imputation
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.11 to 0.07
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)
Hide Description The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number of subjects analysed=subject with data available for 1-hour PPG and pre-prandial PG.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 332 332 326
Mean (Standard Deviation)
Unit of Measure: mmol/L
-1.13  (4.04) 1.04  (3.53) -0.15  (3.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faster Aspart (Meal), NovoRapid (Meal)
Comments Change from baseline in postprandial glucose increment (meal test) is analysed using an analysis of variance model. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline postprandial glucose increment as a covariate.
Type of Statistical Test Superiority
Comments

Stepwise hierarchical testing procedure was applied for confirmatory endpoints:

Step 3: 1-hour postprandial glucose (PPG) increments superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog.

Superiority was confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0.

Statistical Test of Hypothesis P-Value <0.001
Comments p-value from the 2-sided test for treatment difference evaluated at the 5% level.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-1.36 to -0.45
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation
Hide Description The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number of subjects analysed=subject with data available for 1,5-anhydroglucitol.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 341 336 338
Mean (Standard Deviation)
Unit of Measure: ug/mL
0.22  (2.23) -0.15  (2.10) 0.22  (2.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faster Aspart (Meal), NovoRapid (Meal)
Comments Change from baseline in 1,5-anhydroglucitol was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline 1,5-anhydroglucitol as a covariate.
Type of Statistical Test Superiority
Comments

Stepwise hierarchical testing procedure was applied for confirmatory endpoints:

Step 5: 1,5-anhydroglucitol superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.

Superiority was to be confirmed if the lower boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was above 0.

Statistical Test of Hypothesis P-Value 0.924
Comments p-values are from the 2-sided test for treatment difference evaluated at the 5% level.
Method ANOVA model after multiple imputation
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.31 to 0.34
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation
Hide Description The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 339 338 336
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.17  (2.94) 0.44  (3.29) 0.64  (3.35)
5.Secondary Outcome
Title Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation
Hide Description The percentage of subjects who achieved the HbA1c target of <7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.
Time Frame 26 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 28.7 28.2 32.7
No 71.3 71.8 67.3
6.Secondary Outcome
Title Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation
Hide Description The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders.
Time Frame 26 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 25.7 26.4 30.4
No 74.3 73.6 69.6
7.Secondary Outcome
Title Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation
Hide Description The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders.
Time Frame 26 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 16.4 17.9 19.3
No 83.6 82.1 80.7
8.Secondary Outcome
Title Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation
Hide Description Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number of analysed=subject with data available for PPG at individual timepoints.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Mean (Standard Deviation)
Unit of Measure: mmol/L
Change in PPG at 30 min Number Analyzed 333 participants 331 participants 326 participants
-0.47  (3.58) 1.31  (3.52) 0.21  (3.78)
Change in PPG at 1 hour Number Analyzed 333 participants 333 participants 326 participants
-1.05  (4.56) 1.39  (4.44) 0.20  (4.52)
Change in PPG at 2 hours Number Analyzed 329 participants 333 participants 323 participants
-0.41  (5.17) 0.80  (5.38) 0.33  (5.51)
Change in PPG at 3 hours Number Analyzed 332 participants 327 participants 324 participants
-0.12  (5.20) 0.93  (5.06) 0.51  (5.33)
Change in PPG at 4 hours Number Analyzed 330 participants 328 participants 325 participants
0.005  (4.64) 0.83  (4.59) 0.53  (4.60)
9.Secondary Outcome
Title Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation
Hide Description Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number of analysed=subject with data available for PPG and pre-prandial PG at individual timepoints.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Mean (Standard Deviation)
Unit of Measure: mmol/L
Change in PPG increment at 30 min Number Analyzed 332 participants 330 participants 326 participants
-0.55  (2.55) 0.94  (2.47) -0.14  (2.63)
Change in PPG increment at 1 hour Number Analyzed 332 participants 332 participants 326 participants
-1.13  (4.04) 1.04  (3.53) -0.15  (3.78)
Change in PPG increment at 2 hours Number Analyzed 328 participants 331 participants 323 participants
-0.47  (4.74) 0.42  (5.01) -0.01  (5.15)
Change in PPG increment at 3 hours Number Analyzed 331 participants 326 participants 324 participants
-0.20  (4.89) 0.55  (4.95) 0.11  (5.32)
Change in PPG increment at 4 hours Number Analyzed 329 participants 327 participants 325 participants
-0.10  (4.47) 0.45  (4.44) 0.16  (4.63)
10.Secondary Outcome
Title Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile
Hide Description The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number of analysed=subject with data available for 7-9-7 point profile.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 320 327 320
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.304  (1.928) -0.231  (1.846) -0.309  (2.060)
11.Secondary Outcome
Title Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)
Hide Description The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number of analysed=subject with data available data at three profiles: post-breakfast, post-lunch, post-main evening meal.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Mean (Standard Deviation)
Unit of Measure: mmol/L
Change in PPG breakfast Number Analyzed 313 participants 326 participants 316 participants
-0.83  (3.34) -0.03  (3.30) -0.31  (3.18)
Change in PPG lunch Number Analyzed 313 participants 323 participants 318 participants
-0.59  (3.04) 0.06  (2.98) -0.33  (3.38)
Change in PPG main evening meal Number Analyzed 314 participants 321 participants 319 participants
-0.53  (3.55) -0.01  (3.56) -0.14  (3.22)
Change in PPG all meals Number Analyzed 308 participants 317 participants 313 participants
-0.65  (2.26) -0.004  (2.19) -0.25  (2.33)
12.Secondary Outcome
Title Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)
Hide Description The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number of analysed=subject with data available data for PPG values and the PG value before the meal (breakfast, lunch, main evening meal).
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Mean (Standard Deviation)
Unit of Measure: mmol/L
Change in PPG increment breakfast Number Analyzed 313 participants 326 participants 316 participants
-1.14  (3.64) 0.06  (3.51) -0.30  (3.16)
Change in PPG increment lunch Number Analyzed 313 participants 321 participants 317 participants
-0.67  (3.20) -0.08  (3.10) -0.004  (3.31)
Change in PPG increment main evening meal Number Analyzed 313 participants 320 participants 319 participants
-0.29  (3.70) 0.34  (3.54) 0.26  (3.49)
Change in PPG increment all meals Number Analyzed 307 participants 315 participants 313 participants
-0.72  (2.06) 0.08  (1.98) -0.02  (2.01)
13.Secondary Outcome
Title Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile
Hide Description The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number of analysed=subjects who contributed to this analysis.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 331 335 331
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
0.876
(47.490%)
0.875
(40.293%)
0.890
(41.978%)
14.Secondary Outcome
Title Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements
Hide Description The subject was instructed to perform 7-9-7 SMPG point profile on 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast,60 minutes after the start of breakfast,before lunch,60 minutes after the start of lunch, before main evening meal,60 minutes after the start of main evening meal,and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period).
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number of analysed=subjects with available data for nocturnal SMPG measurements.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Mean (Standard Deviation)
Unit of Measure: mmol/L
Change in nocturnal increment-bedtime to 04:00 Number Analyzed 178 participants 208 participants 188 participants
0.14  (5.66) 0.19  (6.41) 0.45  (5.55)
Change in nocturnal increment-bedtime to breakfast Number Analyzed 274 participants 278 participants 278 participants
0.86  (6.21) 0.93  (6.24) 0.33  (5.71)
Change in nocturnal increment-04:00 to breakfast Number Analyzed 176 participants 209 participants 191 participants
0.78  (4.95) 1.01  (4.12) -0.02  (4.17)
15.Secondary Outcome
Title Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L
Hide Description Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.
Time Frame 26 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 27.8 19.9 21.6
No 72.2 80.1 78.4
16.Secondary Outcome
Title Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia
Hide Description Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.
Time Frame 26 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 24.6 18.8 20.5
No 75.4 81.2 79.5
17.Secondary Outcome
Title Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia
Hide Description The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L [140 mg/dL], had HbA1c < 7.0% and had minimal weight gain (increase in body weight from baseline <3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders.
Time Frame 26 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 7.6 4.7 8.2
No 92.4 95.3 91.8
18.Secondary Outcome
Title Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)
Hide Description Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period).
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on FAS. Number analysed=number of subjects with available data for individual lipid parameter.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
HDL cholesterol Number Analyzed 340 participants 340 participants 341 participants
0.981
(16.200%)
0.998
(17.283%)
0.999
(33.056%)
LDL cholesterol Number Analyzed 340 participants 340 participants 341 participants
1.025
(20.067%)
1.053
(22.465%)
1.062
(215.570%)
Total cholesterol Number Analyzed 340 participants 340 participants 341 participants
1.002
(14.561%)
1.030
(15.789%)
1.020
(15.891%)
19.Secondary Outcome
Title Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)
Hide Description The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on safety analysis set (all subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for specified categories.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Mean (Standard Deviation)
Unit of Measure: Units
Daily bolus insulin dose: week 0 Number Analyzed 339 participants 336 participants 335 participants
25.5  (15.4) 25.4  (14.3) 26.6  (14.8)
Daily bolus insulin dose: Last on-treatment value Number Analyzed 341 participants 337 participants 340 participants
31.1  (19.4) 30.5  (18.9) 33.5  (22.5)
Daily basal insulin dose: week 0 Number Analyzed 342 participants 339 participants 339 participants
25.3  (14.5) 26.7  (15.6) 26.2  (15.0)
Daily basal insulin dose: Last on-treatment value Number Analyzed 342 participants 339 participants 340 participants
26.7  (16.6) 27.3  (16.8) 27.2  (17.3)
Total daily insulin dose: week 0 Number Analyzed 339 participants 335 participants 335 participants
50.8  (26.1) 52.2  (25.2) 53.1  (25.9)
Total daily insulin dose: Last on-treatment value Number Analyzed 341 participants 336 participants 340 participants
57.7  (31.4) 57.8  (30.2) 60.4  (34.0)
Daily breakfast bolus insulin dose: Last value Number Analyzed 341 participants 340 participants 340 participants
8.8  (6.2) 8.6  (6.0) 9.5  (7.7)
Daily lunch bolus insulin dose: Last value Number Analyzed 342 participants 340 participants 340 participants
10.5  (7.0) 10.3  (6.9) 11.2  (7.6)
Daily main evening meal bolus insulin: Last value Number Analyzed 342 participants 340 participants 340 participants
11.9  (7.7) 11.6  (7.4) 12.7  (9.1)
Daily other bolus insulin dose: Last value Number Analyzed 166 participants 167 participants 153 participants
4.7  (5.1) 4.3  (3.5) 4.2  (3.3)
20.Secondary Outcome
Title Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation
Hide Description A treatment emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Time Frame Week 0 to week 26 (+7 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: events
649 656 627
21.Secondary Outcome
Title Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation
Hide Description A treatment emergent event was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
Time Frame Week 0 to week 26 (+7 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: Injection site reactions
9 12 10
22.Secondary Outcome
Title Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall
Hide Description

ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia.

NN Classification:

  • Severe:same as per ADA classification
  • Symptomatic blood glucose (BG) confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia
  • Asymptomatic BG confirmed:PG<3.1 mmol/L without symptoms consistent with hypoglycaemia
  • Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with symptoms consistent with hypoglycaemia
  • BG confirmed:PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
  • Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
  • Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period.
Time Frame Week 0 to week 26 (+1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: hypoglycaemic episodes
15760 16579 16520
23.Secondary Outcome
Title Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 – Inclusive)
Hide Description

ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.

NN Classification:

  • Severe: same as per ADA classification
  • Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia
  • Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia
  • Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia
  • BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
  • Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
  • Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive.
Time Frame Week 0 to week 26 (+1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: hypoglycaemic episodes
Daytime hypoglycaemic episodes 14570 15379 15257
Nocturnal hypoglycaemic episodes 1190 1200 1263
24.Secondary Outcome
Title Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal
Hide Description

ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.

NN Classification:

  • Severe: same as per ADA classification
  • Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia
  • Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia
  • Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia
  • BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
  • Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia
  • Unclassifiable Results represent total number of hypoglycaemic episodes related to meals.
Time Frame Week 0 to week 26 (+1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: hypoglycaemic episodes
Within 1 hour after meal 624 614 459
Within 2 hours after meal 1314 1470 1224
Within 4 hours after meal 3920 4794 4129
Between 1 (exclusive) to 2 hours (inclusive) 690 856 765
Between 2 (exclusive) to 3 hours (inclusive) 1236 1634 1302
Between 2 (exclusive) to 4 hours (inclusive) 2606 3324 2905
Between 3 (exclusive) to 4 hours (inclusive) hours 1370 1690 1603
25.Secondary Outcome
Title Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)
Hide Description The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal’, ‘abnormal, not clinically significant' (Abn, NCS) or ‘abnormal, clinically significant’ (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS. Number analysed=number of subjects with available data for physical examinations at specified timepoints.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Cardiovascular system - Week 0: Normal Number Analyzed 342 participants 341 participants 342 participants
97.4 98.8 97.7
Cardiovascular system - Week 0: Abn, NCS Number Analyzed 342 participants 341 participants 342 participants
2.6 0.9 2.0
Cardiovascular system - Week 0: Abn, CS Number Analyzed 342 participants 341 participants 342 participants
0.0 0.3 0.3
Cardiovascular system - Last value: Normal Number Analyzed 340 participants 340 participants 340 participants
97.4 98.8 97.9
Cardiovascular system - Last value: Abn, NCS Number Analyzed 340 participants 340 participants 340 participants
2.6 0.9 1.8
Cardiovascular system - Last value: Abn, CS Number Analyzed 340 participants 340 participants 340 participants
0.0 0.3 0.3
Nervous system - Week 0: Normal Number Analyzed 342 participants 341 participants 342 participants
83.9 86.8 86.3
Nervous system - Week 0: Abn, NCS Number Analyzed 342 participants 341 participants 342 participants
15.5 12.9 13.2
Nervous system - Week 0: Abn, CS Number Analyzed 342 participants 341 participants 342 participants
0.6 0.3 0.6
Nervous system - Last value: Normal Number Analyzed 340 participants 340 participants 340 participants
83.8 87.1 86.8
Nervous system - Last value: Abn, NCS Number Analyzed 340 participants 340 participants 340 participants
15.6 12.9 12.4
Nervous system - Last value: Abn, CS Number Analyzed 340 participants 340 participants 340 participants
0.6 0.0 0.9
Gastrointestinal system-week 0: Normal Number Analyzed 342 participants 341 participants 342 participants
99.7 98.8 98.2
Gastrointestinal system-week 0: Abn, NCS Number Analyzed 342 participants 341 participants 342 participants
0.3 0.9 0.9
Gastrointestinal system-week 0: Abn, CS Number Analyzed 342 participants 341 participants 342 participants
0.0 0.3 0.9
Gastrointestinal system-Last value: Normal Number Analyzed 340 participants 340 participants 340 participants
99.1 97.9 98.5
Gastrointestinal system-Last value: Abn, NCS Number Analyzed 340 participants 340 participants 340 participants
0.9 1.2 0.6
Gastrointestinal system-Last value: Abn, CS Number Analyzed 340 participants 340 participants 340 participants
0.0 0.9 0.9
Head,ears,eyes,nose,throat,neck:week 0-Normal Number Analyzed 342 participants 341 participants 342 participants
95.0 95.6 93.3
Head,ear,eye,nose,throat,neck-week 0:Abn,NCS Number Analyzed 342 participants 341 participants 342 participants
4.1 3.8 5.8
Head,ears,eyes,nose,throat,neck-week 0:Abn,CS Number Analyzed 342 participants 341 participants 342 participants
0.9 0.6 0.9
Head,ears,eyes,nose,throat,neck-Last value:Normal Number Analyzed 340 participants 340 participants 340 participants
95.3 92.9 94.1
Head,ear,eye,nose,throat,neck-Last value:Abn,NCS Number Analyzed 340 participants 340 participants 340 participants
3.8 6.2 4.4
Head,ear,eye,nose,throat,neck-Last value:Abn,CS Number Analyzed 340 participants 340 participants 340 participants
0.9 0.9 1.5
Musculoskeletal system-week 0: Normal Number Analyzed 342 participants 341 participants 342 participants
95.9 97.1 96.2
Musculoskeletal system-week 0: Abn, NCS Number Analyzed 342 participants 341 participants 342 participants
4.1 2.9 3.5
Musculoskeletal system-week 0: Abn, CS Number Analyzed 342 participants 341 participants 342 participants
0.0 0.0 0.3
Musculoskeletal system-Last value: Normal Number Analyzed 340 participants 340 participants 340 participants
96.8 97.4 95.3
Musculoskeletal system-Last value: Abn, NCS Number Analyzed 340 participants 340 participants 340 participants
3.2 2.6 3.8
Musculoskeletal system-Last value: Abn, CS Number Analyzed 340 participants 340 participants 340 participants
0.0 0.0 0.9
Respiratory system-week 0: Normal Number Analyzed 342 participants 341 participants 342 participants
99.4 99.4 99.1
Respiratory system-week 0: Abn, NCS Number Analyzed 342 participants 341 participants 342 participants
0.6 0.3 0.6
Respiratory system-week 0: Abn, CS Number Analyzed 342 participants 341 participants 342 participants
0.0 0.3 0.3
Respiratory system-Last value: Normal Number Analyzed 340 participants 340 participants 340 participants
99.7 99.4 99.4
Respiratory system-Last value: Abn, NCS Number Analyzed 340 participants 340 participants 340 participants
0.3 0.3 0.3
Respiratory system-Last value: Abn, CS Number Analyzed 340 participants 340 participants 340 participants
0.0 0.3 0.3
Skin-week 0: Normal Number Analyzed 342 participants 341 participants 342 participants
91.5 89.7 91.5
Skin-week 0: Abn, NCS Number Analyzed 342 participants 341 participants 342 participants
7.3 8.8 7.9
Skin-week 0: Abn, CS Number Analyzed 342 participants 341 participants 342 participants
1.2 1.5 0.6
Skin-Last value: Normal Number Analyzed 340 participants 340 participants 340 participants
91.5 91.5 92.4
Skin-Last value: Abn, NCS Number Analyzed 340 participants 340 participants 340 participants
7.6 6.2 6.5
Skin-Last value: Abn, CS Number Analyzed 340 participants 340 participants 340 participants
0.9 2.4 1.2
26.Secondary Outcome
Title Change From Baseline in Blood Pressure 26 Weeks After Randomisation
Hide Description Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS. Number of subjects analysed=subjects with available data for blood pressure
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 340 340
Mean (Standard Deviation)
Unit of Measure: mmHg
Diastolic blood pressure 0.5  (8.3) 0.2  (7.8) 0.8  (7.9)
Systolic blood pressure 0.6  (12.5) 1.4  (10.8) 0.8  (12.9)
27.Secondary Outcome
Title Change From Baseline in Pulse 26 Weeks After Randomisation
Hide Description Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS. Number of subjects analysed=subjects with available data for pulse.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 340 340
Mean (Standard Deviation)
Unit of Measure: beats/minute
0.0  (8.8) -0.7  (9.3) 0.7  (8.3)
28.Secondary Outcome
Title Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation
Hide Description The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS. Number analysed=number of subjects with available data for electrocardiogram at specified timepoints.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Week 0: Normal Number Analyzed 342 participants 341 participants 342 participants
80.7 81.8 84.2
Week 0: Abn, NCS Number Analyzed 342 participants 341 participants 342 participants
19.3 17.6 15.8
Week 0: Abn, CS Number Analyzed 342 participants 341 participants 342 participants
0.0 0.6 0.0
Last on-treatment value: Normal Number Analyzed 339 participants 338 participants 333 participants
80.8 84.0 82.3
Last on-treatment value: Abn, NCS Number Analyzed 339 participants 338 participants 333 participants
19.2 15.1 17.1
Last on-treatment value: Abn, CS Number Analyzed 339 participants 338 participants 333 participants
0.0 0.9 0.6
29.Secondary Outcome
Title Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation
Hide Description The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS. Number analysed=number of subjects with available data for fundoscopy/fundus photography at specified timepoints.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Left eye-Week 0: Normal Number Analyzed 342 participants 341 participants 342 participants
65.8 68.0 69.3
Left eye-Week 0: Abn, NCS Number Analyzed 342 participants 341 participants 342 participants
26.9 23.5 23.4
Left eye-Week 0: Abn, CS Number Analyzed 342 participants 341 participants 342 participants
7.3 8.5 7.3
Left eye-Last on-treatment value: Normal Number Analyzed 333 participants 333 participants 332 participants
62.5 69.4 69.3
Left eye-Last on-treatment value: Abn, NCS Number Analyzed 333 participants 333 participants 332 participants
29.7 21.0 21.1
Left eye-Last on-treatment value: Abn, CS Number Analyzed 333 participants 333 participants 332 participants
7.8 9.6 9.6
Right eye-Week 0: Normal Number Analyzed 342 participants 341 participants 342 participants
65.2 68.9 67.0
Right eye-Week 0: Abn, NCS Number Analyzed 342 participants 341 participants 342 participants
27.8 22.3 25.4
Right eye-Week 0: Abn, CS Number Analyzed 342 participants 341 participants 342 participants
7.0 8.8 7.6
Right eye-Last on-treatment value: Normal Number Analyzed 333 participants 333 participants 332 participants
64.0 67.9 68.7
Right eye-Last on-treatment value: Abn, NCS Number Analyzed 333 participants 333 participants 332 participants
29.1 22.5 22.6
Right eye-Last on-treatment value: Abn, CS Number Analyzed 333 participants 333 participants 332 participants
6.9 9.6 8.7
30.Secondary Outcome
Title Change From Baseline in Erythrocytes 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for erythrocytes measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 340 340
Mean (Standard Deviation)
Unit of Measure: number of erythrocytes 10^12/L
-0.01  (0.24) -0.03  (0.26) -0.02  (0.26)
31.Secondary Outcome
Title Change From Baseline in Haematocrit 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haematocrit measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 340 340
Mean (Standard Deviation)
Unit of Measure: percentage of red blood cells in blood
-0.48  (2.58) -0.52  (2.41) -0.57  (2.45)
32.Secondary Outcome
Title Change From Baseline in Haemoglobin 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haemoglobin measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 340 340
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.04  (0.51) -0.04  (0.46) -0.05  (0.50)
33.Secondary Outcome
Title Change From Baseline in Leukocytes 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for leukocytes measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 340 340
Mean (Standard Deviation)
Unit of Measure: Number of leukocytes 10^9/L
-0.17  (1.63) -0.03  (1.52) -0.01  (1.46)
34.Secondary Outcome
Title Change From Baseline in Thrombocytes 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for thrombocytes measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 339 339
Mean (Standard Deviation)
Unit of Measure: Number of thrombocytes 10^9/L
-0.7  (40.0) -2.0  (36.3) -1.8  (33.7)
35.Secondary Outcome
Title Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alanine aminotransferase measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 339 340
Mean (Standard Deviation)
Unit of Measure: U/L
1.3  (10.1) 0.9  (9.0) 0.6  (11.6)
36.Secondary Outcome
Title Change From Baseline in Albumin 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for albumin measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 339 340
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.02  (0.25) -0.05  (0.25) -0.03  (0.25)
37.Secondary Outcome
Title Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alkaline phosphatase measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 339 340
Mean (Standard Deviation)
Unit of Measure: U/L
2.1  (18.9) 1.4  (12.3) -0.2  (14.4)
38.Secondary Outcome
Title Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for aspartate aminotransferase measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 339 339
Mean (Standard Deviation)
Unit of Measure: U/L
-0.0  (9.5) -0.1  (9.4) -0.3  (13.3)
39.Secondary Outcome
Title Change From Baseline in Total Bilirubin 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total bilirubin measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 339 340
Mean (Standard Deviation)
Unit of Measure: umol/L
-0.1  (3.3) -0.2  (3.9) -0.2  (3.3)
40.Secondary Outcome
Title Change From Baseline in Potassium 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for potassium measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 339 339
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.01  (0.43) 0.04  (0.42) 0.04  (0.43)
41.Secondary Outcome
Title Change From Baseline in Creatinine 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for creatinine measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 339 340
Mean (Standard Deviation)
Unit of Measure: umol/L
2.0  (8.8) 1.8  (7.5) 1.8  (15.6)
42.Secondary Outcome
Title Change From Baseline in Total Protein 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total protein measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 339 340
Mean (Standard Deviation)
Unit of Measure: g/dL
0.03  (0.40) 0.02  (0.37) -0.02  (0.36)
43.Secondary Outcome
Title Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation
Hide Description Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for urinary albumin and creatinine measurement.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 339 340
Mean (Standard Deviation)
Unit of Measure: mg/mmol
0.636  (7.361) -0.379  (11.095) 0.656  (12.739)
44.Secondary Outcome
Title Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation
Hide Description Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS. Number analysed=number of subjects with available data for ketones values.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Week 0: Negative Number Analyzed 342 participants 341 participants 342 participants
96.2 97.1 92.7
Week 0: Positive Number Analyzed 342 participants 341 participants 342 participants
0.0 0.0 0.0
Week 0: Trace Number Analyzed 342 participants 341 participants 342 participants
2.0 1.8 5.3
Week 0: 1+ Number Analyzed 342 participants 341 participants 342 participants
1.8 1.2 1.8
Week 0: 2+ Number Analyzed 342 participants 341 participants 342 participants
0.0 0.0 0.3
Week 0: 3+ Number Analyzed 342 participants 341 participants 342 participants
0.0 0.0 0.0
Last on-treatment value: Negative Number Analyzed 339 participants 339 participants 340 participants
92.3 89.7 90.0
Last on-treatment value:Positive Number Analyzed 339 participants 339 participants 340 participants
0.0 0.0 0.0
Last on-treatment value: Trace Number Analyzed 339 participants 339 participants 340 participants
5.0 6.5 6.5
Last on-treatment value:1+ Number Analyzed 339 participants 339 participants 340 participants
2.1 3.2 2.9
Last on-treatment value: 2+ Number Analyzed 339 participants 339 participants 340 participants
0.6 0.6 0.6
Last on-treatment value: 3+ Number Analyzed 339 participants 339 participants 340 participants
0.0 0.0 0.0
45.Secondary Outcome
Title Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation
Hide Description Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS. Number analysed=number of subjects with available data for protein values.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Week 0: Negative Number Analyzed 342 participants 341 participants 342 participants
82.2 79.5 80.4
Week 0: Positive Number Analyzed 342 participants 341 participants 342 participants
0.0 0.0 0.0
Week 0: Trace Number Analyzed 342 participants 341 participants 342 participants
12.0 14.4 13.5
Week 0: 1+ Number Analyzed 342 participants 341 participants 342 participants
4.4 4.1 3.5
Week 0: 2+ Number Analyzed 342 participants 341 participants 342 participants
1.2 1.2 2.0
Week 0: 3+ Number Analyzed 342 participants 341 participants 342 participants
0.3 0.9 0.6
Last on-treatment value: Negative Number Analyzed 339 participants 339 participants 340 participants
83.5 82.6 78.8
Last on-treatment value:Positive Number Analyzed 339 participants 339 participants 340 participants
0.0 0.0 0.0
Last on-treatment value: Trace Number Analyzed 339 participants 339 participants 340 participants
8.6 10.9 12.4
Last on-treatment value:1+ Number Analyzed 339 participants 339 participants 340 participants
5.9 4.7 6.5
Last on-treatment value: 2+ Number Analyzed 339 participants 339 participants 340 participants
1.5 1.2 2.1
Last on-treatment value: 3+ Number Analyzed 339 participants 339 participants 340 participants
0.6 0.6 0.3
46.Secondary Outcome
Title Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation
Hide Description Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS. Number analysed=number of subjects with available data for erythrocytes values.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Measure Type: Number
Unit of Measure: percentage of subjects
Week 0: Negative Number Analyzed 342 participants 341 participants 342 participants
95.3 93.3 93.3
Week 0: Positive Number Analyzed 342 participants 341 participants 342 participants
0.0 0.0 0.0
Week 0: Trace Number Analyzed 342 participants 341 participants 342 participants
1.8 2.3 3.2
Week 0: 1+ Number Analyzed 342 participants 341 participants 342 participants
0.9 1.5 2.0
Week 0: 2+ Number Analyzed 342 participants 341 participants 342 participants
1.2 0.9 0.6
Week 0: 3+ Number Analyzed 342 participants 341 participants 342 participants
0.9 2.1 0.9
Last on-treatment value: Negative Number Analyzed 339 participants 339 participants 340 participants
93.5 91.7 91.8
Last on-treatment value:Positive Number Analyzed 339 participants 339 participants 340 participants
0.0 0.0 0.0
Last on-treatment value: Trace Number Analyzed 339 participants 339 participants 340 participants
2.7 3.8 2.6
Last on-treatment value:1+ Number Analyzed 339 participants 339 participants 340 participants
1.5 0.9 2.1
Last on-treatment value: 2+ Number Analyzed 339 participants 339 participants 340 participants
0.6 2.1 1.8
Last on-treatment value: 3+ Number Analyzed 339 participants 339 participants 340 participants
1.8 1.5 1.8
47.Secondary Outcome
Title Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation
Hide Description Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T).
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on the SAS. Number analysed=number of subjects with available data for anti-insulin aspart antibody.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 342 341 342
Mean (Standard Deviation)
Unit of Measure: % B/T
Anti-insulin aspart specific antibodies Number Analyzed 337 participants 333 participants 333 participants
0.033  (0.777) -0.027  (1.077) -0.013  (1.568)
Cross-reacting to human insulin Number Analyzed 337 participants 334 participants 332 participants
-0.972  (6.028) -1.799  (6.812) -1.427  (5.527)
48.Secondary Outcome
Title Change From Baseline in Body Weight 26 Weeks After Randomisation
Hide Description The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS. Number of subjects analysed=subject with data available for body weight.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 340 340
Mean (Standard Deviation)
Unit of Measure: kg
1.43  (2.66) 1.14  (2.95) 1.24  (2.60)
49.Secondary Outcome
Title Change From Baseline in Body Mass Index 26 Weeks After Randomisation
Hide Description The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on SAS. Number of subjects analysed=subject with data available for body mass index.
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Overall Number of Participants Analyzed 340 340 340
Mean (Standard Deviation)
Unit of Measure: kg/m^2
0.49  (0.91) 0.39  (1.02) 0.43  (0.89)
Time Frame Week 0 to week 26 (+7 days)
Adverse Event Reporting Description A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.
 
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 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0−2 minutes before the meal) during 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 glycaemic target of pre-prandial and bedtime plasma glucose between 4.0–6.0 mmol/L (71–108 mg/dL) in a treat-to-target fashion.

Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period.

All-Cause Mortality
Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/342 (0.00%)      0/341 (0.00%)      0/342 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/342 (5.85%)      17/341 (4.99%)      17/342 (4.97%)    
Gastrointestinal disorders       
Gastritis  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Gastrooesophageal reflux disease  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
General disorders       
Chest pain  1  0/342 (0.00%)  0 1/341 (0.29%)  1 0/342 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis  1  0/342 (0.00%)  0 0/341 (0.00%)  0 1/342 (0.29%)  1
Infections and infestations       
Cellulitis  1  0/342 (0.00%)  0 1/341 (0.29%)  1 0/342 (0.00%)  0
Diverticulitis  1  0/342 (0.00%)  0 0/341 (0.00%)  0 1/342 (0.29%)  1
Pilonidal cyst  1  0/342 (0.00%)  0 1/341 (0.29%)  1 0/342 (0.00%)  0
Urinary tract infection  1  0/342 (0.00%)  0 0/341 (0.00%)  0 1/342 (0.29%)  1
Injury, poisoning and procedural complications       
Extradural haematoma  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Fall  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Femoral neck fracture  1  0/342 (0.00%)  0 0/341 (0.00%)  0 1/342 (0.29%)  1
Forearm fracture  1  0/342 (0.00%)  0 1/341 (0.29%)  1 0/342 (0.00%)  0
Postoperative ileus  1  0/342 (0.00%)  0 1/341 (0.29%)  1 0/342 (0.00%)  0
Radius fracture  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Road traffic accident  1  0/342 (0.00%)  0 1/341 (0.29%)  1 0/342 (0.00%)  0
Skull fractured base  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Tendon rupture  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Ulna fracture  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Wrong drug administered  1  0/342 (0.00%)  0 0/341 (0.00%)  0 2/342 (0.58%)  2
Investigations       
Blood glucose fluctuation  1  0/342 (0.00%)  0 0/341 (0.00%)  0 1/342 (0.29%)  1
Metabolism and nutrition disorders       
Diabetic metabolic decompensation  1  1/342 (0.29%)  1 1/341 (0.29%)  1 1/342 (0.29%)  1
Hypoglycaemia  1  8/342 (2.34%)  8 3/341 (0.88%)  6 6/342 (1.75%)  6
Hypoglycaemia unawareness  1  0/342 (0.00%)  0 1/341 (0.29%)  1 0/342 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Bursitis  1  0/342 (0.00%)  0 1/341 (0.29%)  1 0/342 (0.00%)  0
Collagen disorder  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Intervertebral disc disorder  1  0/342 (0.00%)  0 1/341 (0.29%)  1 0/342 (0.00%)  0
Intervertebral disc protrusion  1  0/342 (0.00%)  0 0/341 (0.00%)  0 1/342 (0.29%)  1
Trigger finger  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder transitional cell carcinoma  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident  1  0/342 (0.00%)  0 1/341 (0.29%)  1 0/342 (0.00%)  0
Diabetic neuropathy  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Hypoglycaemic coma  1  0/342 (0.00%)  0 0/341 (0.00%)  0 1/342 (0.29%)  1
Hypoglycaemic seizure  1  2/342 (0.58%)  2 1/341 (0.29%)  1 0/342 (0.00%)  0
Hypoglycaemic unconsciousness  1  2/342 (0.58%)  2 3/341 (0.88%)  3 2/342 (0.58%)  2
Polyneuropathy  1  0/342 (0.00%)  0 2/341 (0.59%)  2 0/342 (0.00%)  0
Psychiatric disorders       
Depression  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Surgical and medical procedures       
Haemorrhoid operation  1  1/342 (0.29%)  1 0/341 (0.00%)  0 0/342 (0.00%)  0
Inguinal hernia repair  1  0/342 (0.00%)  0 0/341 (0.00%)  0 1/342 (0.29%)  1
1
Term from vocabulary, MedDRA 20
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Faster Aspart (Meal) Faster Aspart (Post) NovoRapid (Meal)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   154/342 (45.03%)      152/341 (44.57%)      161/342 (47.08%)    
Infections and infestations       
Influenza  1  21/342 (6.14%)  22 14/341 (4.11%)  14 10/342 (2.92%)  10
Upper respiratory tract infection  1  30/342 (8.77%)  38 26/341 (7.62%)  34 27/342 (7.89%)  34
Viral upper respiratory tract infection  1  73/342 (21.35%)  101 70/341 (20.53%)  100 80/342 (23.39%)  118
Investigations       
Blood glucose decreased  1  58/342 (16.96%)  81 67/341 (19.65%)  83 68/342 (19.88%)  82
1
Term from vocabulary, MedDRA 20
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Reporting Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
Phone: (+1) 866-867-7178
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02500706     History of Changes
Other Study ID Numbers: NN1218-4131
2015-001047-36 ( EudraCT Number )
U1111-1167-9495 ( Other Identifier: WHO )
First Submitted: July 15, 2015
First Posted: July 16, 2015
Results First Submitted: July 16, 2018
Results First Posted: August 10, 2018
Last Update Posted: June 12, 2019