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Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes (onset 9)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03268005
Recruitment Status : Completed
First Posted : August 31, 2017
Results First Posted : February 5, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: Faster-acting insulin aspart
Drug: Insulin aspart
Drug: Insulin degludec
Drug: Metformin
Enrollment 1264
Recruitment Details The trial was conducted at 165 sites in 17 countries as follows: Argentina-3, Bulgaria-4, Canada-10, Croatia-4, Czech Republic-4, Germany-6, Greece-8, Italy-4, Poland-10, Republic of Korea-6, Romania-6, Russia-8, Serbia-9, Slovakia-5, Spain-8, Ukraine-6 and United States (US)-62. Two sites in the US screened but didn’t randomise any subject.
Pre-assignment Details There was a 12-week run-in period primarily for optimisation of the basal insulin and reinforcement of subject training in trial procedures, diabetes education and dietary training. Out of the 1264 participants enrolled in the study, 173 were run-in failures and 1091 were randomised.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion. Participants received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Period Title: Overall Study
Started 546 545
Full Analysis Set 546 545
Safety Analysis Set 544 544
Completed 531 531
Not Completed 15 14
Reason Not Completed
Death             2             1
Lost to Follow-up             2             2
Withdrawal by Subject             11             11
Arm/Group Title Faster Aspart NovoRapid Total
Hide Arm/Group Description Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion. Participants received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion. Total of all reporting groups
Overall Number of Baseline Participants 546 545 1091
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 546 participants 545 participants 1091 participants
62.6  (8.6) 62.1  (8.8) 62.3  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 546 participants 545 participants 1091 participants
Female
281
  51.5%
256
  47.0%
537
  49.2%
Male
265
  48.5%
289
  53.0%
554
  50.8%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 546 participants 545 participants 1091 participants
White
487
  89.2%
487
  89.4%
974
  89.3%
Asian
43
   7.9%
31
   5.7%
74
   6.8%
Black or African American
14
   2.6%
19
   3.5%
33
   3.0%
Native Hawaiian or Other Pacific Islander
2
   0.4%
5
   0.9%
7
   0.6%
Other
0
   0.0%
3
   0.6%
3
   0.3%
[1]
Measure Description: Race
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 546 participants 545 participants 1091 participants
Not Hispanic or Latino
485
  88.8%
488
  89.5%
973
  89.2%
Hispanic Latino
61
  11.2%
57
  10.5%
118
  10.8%
[1]
Measure Description: Ethnicity
1.Primary Outcome
Title Change in Glycosylated Haemoglobin (HbA1c)
Hide Description Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 539
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c
-0.15  (0.62) -0.09  (0.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faster Aspart, NovoRapid
Comments Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, region and metformin use at baseline (Yes/No) as factors, and baseline HbA1c as a covariate.
Type of Statistical Test Non-Inferiority
Comments The upper limit of the 95% confidence interval for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4% non-inferiority was considered established and effect demonstrated.
Statistical Test of Hypothesis P-Value 0.310
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.11 to 0.03
Estimation Comments Faster aspart-NovoRapid
2.Secondary Outcome
Title Change From Baseline in 1-hour PPG Increment
Hide Description Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 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 observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 519 523
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.43  (2.45) 0.08  (2.65)
3.Secondary Outcome
Title Change From Baseline in 1,5-anhydroglucitol
Hide Description Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 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 observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 534 531
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.38  (3.10) 0.89  (3.31)
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG)
Hide Description Change from baseline (week 0) in fasting plasma glucose was evaluated after 16 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 observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 533 530
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.56  (2.38) 0.68  (2.40)
5.Secondary Outcome
Title Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No)
Hide Description Number of participants reaching HbA1c <7.0% (53 mmol/L) was evaluated after 16 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 observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame 16 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 546 545
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
271
  49.6%
282
  51.7%
No
275
  50.4%
263
  48.3%
6.Secondary Outcome
Title Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)
Hide Description Number of participants reaching HbA1c <7.0% (53 mmol/L) without severe hypoglycaemia episodes was evaluated after 16 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 observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame 16 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 546 545
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
265
  48.5%
278
  51.0%
No
281
  51.5%
267
  49.0%
7.Secondary Outcome
Title Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])
Hide Description Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 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 observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 546 545
Mean (Standard Deviation)
Unit of Measure: mmol/L
30-min Number Analyzed 519 participants 522 participants
0.31  (2.90) 0.55  (2.80)
1-hour Number Analyzed 521 participants 526 participants
0.03  (3.30) 0.68  (3.23)
2-hour Number Analyzed 519 participants 524 participants
0.08  (3.96) 0.61  (3.48)
3-hour Number Analyzed 518 participants 519 participants
0.30  (3.85) 0.89  (3.72)
4-hour Number Analyzed 514 participants 519 participants
0.51  (3.47) 0.75  (3.51)
8.Secondary Outcome
Title Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)
Hide Description Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 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 observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal. PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 546 545
Mean (Standard Deviation)
Unit of Measure: mmol/L
30-min Number Analyzed 518 participants 519 participants
-0.13  (1.85) -0.05  (1.95)
1-hour Number Analyzed 519 participants 523 participants
-0.43  (2.45) 0.08  (2.65)
2-hour Number Analyzed 517 participants 521 participants
-0.37  (3.25) 0.001  (3.13)
3-hour Number Analyzed 516 participants 516 participants
-0.15  (3.23) 0.28  (3.54)
4-hour Number Analyzed 513 participants 516 participants
0.04  (3.00) 0.15  (3.45)
9.Secondary Outcome
Title Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile
Hide Description Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-9-7 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 454 464
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.56  (1.66) -0.50  (1.61)
10.Secondary Outcome
Title Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)
Hide Description Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 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 observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 546 545
Mean (Standard Deviation)
Unit of Measure: mmol/L
Breakfast Number Analyzed 447 participants 462 participants
-0.38  (2.53) -0.28  (2.44)
Lunch Number Analyzed 453 participants 462 participants
-0.78  (2.48) -0.58  (2.68)
Main evening meal Number Analyzed 447 participants 459 participants
-1.04  (2.67) -0.71  (2.50)
All meals Number Analyzed 440 participants 457 participants
-0.75  (1.89) -0.52  (1.91)
11.Secondary Outcome
Title Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)
Hide Description Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. PPG increment based on the 7-9-7-point profiles were derived separately for PG measurements made at 1 hour after main meals (breakfast, lunch and main evening meal). PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 546 545
Mean (Standard Deviation)
Unit of Measure: mmol/L
Breakfast Number Analyzed 447 participants 461 participants
-0.56  (2.23) -0.42  (2.17)
Lunch Number Analyzed 453 participants 460 participants
-0.38  (2.69) -0.23  (2.46)
Main evening meal Number Analyzed 444 participants 459 participants
-0.44  (2.61) -0.10  (2.28)
All meals Number Analyzed 438 participants 455 participants
-0.48  (1.55) -0.23  (1.42)
12.Secondary Outcome
Title Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile
Hide Description Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-9-7 point SMPG profile from baseline (week 0) after 16 weeks of randomisation (i.e., week 16). The results are presented as ratio to baseline. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 454 464
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
0.82
(48.32%)
0.85
(55.06%)
13.Secondary Outcome
Title Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements
Hide Description Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 546 545
Mean (Standard Deviation)
Unit of Measure: mmol/L
Bedtime to 04:00 Number Analyzed 343 participants 347 participants
0.70  (4.09) 0.29  (4.09)
Bedtime to breakfast Number Analyzed 419 participants 438 participants
1.30  (4.25) 0.90  (3.99)
04:00 to breakfast Number Analyzed 351 participants 355 participants
0.66  (2.76) 0.75  (2.87)
14.Secondary Outcome
Title Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No)
Hide Description Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame 16 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 546 545
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
186
  34.1%
192
  35.2%
No
360
  65.9%
353
  64.8%
15.Secondary Outcome
Title Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No)
Hide Description Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame 16 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 546 545
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
182
  33.3%
190
  34.9%
No
364
  66.7%
355
  65.1%
16.Secondary Outcome
Title Total Bolus Insulin Dose: in Units/Day
Hide Description Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame 16 weeks from randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 542
Mean (Standard Deviation)
Unit of Measure: Units/day
54.72  (35.82) 53.38  (35.35)
17.Secondary Outcome
Title Total Bolus Insulin Dose: in Units/kg/Day
Hide Description Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame 16 weeks from randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 542
Mean (Standard Deviation)
Unit of Measure: Units/kg/day
0.57  (0.33) 0.55  (0.34)
18.Secondary Outcome
Title Total Basal Insulin Dose: in Units/Day
Hide Description Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame 16 weeks from randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 542
Mean (Standard Deviation)
Unit of Measure: Units/day
63.76  (35.21) 62.25  (36.03)
19.Secondary Outcome
Title Total Basal Insulin Dose: in Units/kg/Day
Hide Description Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame 16 weeks from randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 542
Mean (Standard Deviation)
Unit of Measure: Units/kg/day
0.66  (0.32) 0.64  (0.32)
20.Secondary Outcome
Title Individual Meal Insulin Dose: in Units
Hide Description Individual meal time bolus insulin dose (Units) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame 16 weeks from randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Mean (Standard Deviation)
Unit of Measure: Units
Breakfast Number Analyzed 544 participants 543 participants
16.27  (12.04) 15.52  (11.38)
Lunch Number Analyzed 544 participants 543 participants
18.51  (12.09) 17.96  (11.73)
Daily main evening meal Number Analyzed 544 participants 542 participants
19.88  (13.46) 19.85  (14.47)
21.Secondary Outcome
Title Individual Meal Insulin Dose: in Units/kg
Hide Description Individual meal time bolus insulin dose (Units/kg) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame 16 weeks from randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Mean (Standard Deviation)
Unit of Measure: Units/kg
Breakfast Number Analyzed 544 participants 543 participants
0.17  (0.12) 0.16  (0.11)
Lunch Number Analyzed 544 participants 543 participants
0.19  (0.11) 0.19  (0.12)
Daily main evening meal Number Analyzed 544 participants 542 participants
0.21  (0.13) 0.20  (0.14)
22.Secondary Outcome
Title Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline
Hide Description Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values are given as ratio to baseline (week 0) after 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 546 545
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
Total cholesterol Number Analyzed 542 participants 537 participants
1.01
(15.98%)
1.00
(17.09%)
High density lipoproteins Number Analyzed 542 participants 537 participants
0.97
(14.47%)
0.98
(17.57%)
Low density lipoproteins Number Analyzed 542 participants 537 participants
0.99
(25.36%)
0.99
(40.51%)
23.Secondary Outcome
Title Number of Treatment Emergent Adverse Events
Hide Description Number of treatment emergent adverse events were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Number
Unit of Measure: Events
667 643
24.Secondary Outcome
Title Number of Treatment Emergent Injection Site Reactions
Hide Description Number of treatment emergent injection site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Number
Unit of Measure: Number of injection site reactions
3 1
25.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall
Hide Description

ADA classification of hypos:

  1. Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.
  2. Documented symptomatic: PG ≤3.9 mmol/L with symptoms.
  3. Asymptomatic: PG ≤3.9 mmol/L without symptoms.
  4. Probable symptomatic: No measurement with symptoms.
  5. Pseudo: PG >3.9 mmol/L with symptoms.
  6. Unclassifiable.

NN classification of hypos:

  1. BG confirmed: PG <3.1 mmol/L with/without symptoms.
  2. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms.
  3. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms.
  4. Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 18 14
ADA: Documented symptomatic 5038 6165
ADA: Asymptomatic 3761 3681
ADA: Probable symptomatic 68 68
ADA: Pseudo 145 75
ADA: Unclassifiable 3 3
NN: BG confirmed 2209 2735
NN: Severe or BG confirmed symptomatic 1490 2055
NN: Severe or BG confirmed 2227 2749
NN: Unclassifiable 6806 7257
Not able to selftreat - unclassifiable 0 0
26.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)
Hide Description Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 16 12
ADA: Documented symptomatic 4703 5700
ADA: Asymptomatic 3617 3484
ADA: Probable symptomatic 62 64
ADA: Pseudo 141 66
ADA: Unclassifiable 3 3
NN: BG confirmed 2016 2442
NN: Severe or BG confirmed symptomatic 1333 1814
NN: Severe or BG confirmed 2032 2454
NN: Unclassifiable 6510 6875
Not able to selftreat - unclassifiable 0 0
27.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)
Hide Description Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 2 2
ADA: Documented symptomatic 335 465
ADA: Asymptomatic 144 197
ADA: Probable symptomatic 6 4
ADA: Pseudo 4 9
ADA: Unclassifiable 0 0
NN: BG confirmed 193 293
NN: Severe or BG confirmed symptomatic 157 241
NN: Severe or BG confirmed 195 295
NN: Unclassifiable 296 382
Not able to selftreat - unclassifiable 0 0
28.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal
Hide Description Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 2 0
ADA: Documented symptomatic 149 148
ADA: Asymptomatic 87 80
ADA: Probable symptomatic 11 8
ADA: Pseudo 2 4
ADA: Unclassifiable 0 0
NN: BG confirmed 72 65
NN: Severe or BG confirmed symptomatic 48 50
NN: Severe or BG confirmed 74 65
NN: Unclassifiable 177 175
Not able to selftreat - unclassifiable 0 0
29.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal
Hide Description Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 2 1
ADA: Documented symptomatic 465 446
ADA: Asymptomatic 201 159
ADA: Probable symptomatic 16 11
ADA: Pseudo 10 7
ADA: Unclassifiable 0 0
NN: BG confirmed 233 246
NN: Severe or BG confirmed symptomatic 181 212
NN: Severe or BG confirmed 235 247
NN: Unclassifiable 459 377
Not able to selftreat - unclassifiable 0 0
30.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal
Hide Description Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 6 9
ADA: Documented symptomatic 1627 1882
ADA: Asymptomatic 852 744
ADA: Probable symptomatic 37 27
ADA: Pseudo 55 26
ADA: Unclassifiable 0 0
NN: BG confirmed 762 965
NN: Severe or BG confirmed symptomatic 557 820
NN: Severe or BG confirmed 768 974
NN: Unclassifiable 1809 1714
Not able to selftreat - unclassifiable 0 0
31.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal
Hide Description Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Number
Unit of Measure: Number of hypoglycaemic episodes
ADA: Severe 4 8
ADA: Documented symptomatic 1162 1436
ADA: Asymptomatic 651 585
ADA: Probable symptomatic 21 16
ADA: Pseudo 45 19
ADA: Unclassifiable 0 0
NN: BG confirmed 529 719
NN: Severe or BG confirmed symptomatic 376 608
NN: Severe or BG confirmed 533 727
NN: Unclassifiable 1350 1337
Not able to selftreat - unclassifiable 0 0
32.Secondary Outcome
Title Change From Baseline in Physical Examination
Hide Description Participants with physical examination findings, normal, abnormal NCS (non- clinically significant) and abnormal CS (clinically significant) at baseline (week 0) and week 16 presented. Results are based on the data from the on-treatment observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system 2) Central & Peripheral nervous system 3) Gastrointestinal system incl. mouth 4) Head, ears, eyes, nose, throat and neck 5) Musculoskeletal system 6) Respiratory system 7) Skin
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Count of Participants
Unit of Measure: Participants
Cardiovascular system (week 0) Number Analyzed 544 participants 544 participants
Normal
459
  84.4%
460
  84.6%
Abnormal NCS
79
  14.5%
79
  14.5%
Abnormal CS
6
   1.1%
5
   0.9%
Cardiovascular system (week 16) Number Analyzed 525 participants 533 participants
Normal
448
  85.3%
457
  85.7%
Abnormal NCS
71
  13.5%
72
  13.5%
Abnormal CS
6
   1.1%
4
   0.8%
Central and Peripheral nervous sys. (week 0) Number Analyzed 544 participants 544 participants
Normal
398
  73.2%
404
  74.3%
Abnormal NCS
133
  24.4%
127
  23.3%
Abnormal CS
13
   2.4%
13
   2.4%
Central and Peripheral nervous sys. (week 16) Number Analyzed 525 participants 533 participants
Normal
383
  73.0%
400
  75.0%
Abnormal NCS
128
  24.4%
122
  22.9%
Abnormal CS
14
   2.7%
11
   2.1%
Gastrointestinal sys. including mouth (Week 0) Number Analyzed 544 participants 544 participants
Normal
491
  90.3%
485
  89.2%
Abnormal NCS
53
   9.7%
59
  10.8%
Abnormal CS
0
   0.0%
0
   0.0%
Gastrointestinal sys. including mouth (week 16) Number Analyzed 525 participants 533 participants
Normal
480
  91.4%
476
  89.3%
Abnormal NCS
45
   8.6%
57
  10.7%
Abnormal CS
0
   0.0%
0
   0.0%
Head, ears, eyes, nose, throat, neck (week 0) Number Analyzed 544 participants 544 participants
Normal
498
  91.5%
492
  90.4%
Abnormal NCS
43
   7.9%
48
   8.8%
Abnormal CS
3
   0.6%
4
   0.7%
Head, ears, eyes, nose, throat, neck (week 16) Number Analyzed 525 participants 533 participants
Normal
485
  92.4%
483
  90.6%
Abnormal NCS
40
   7.6%
49
   9.2%
Abnormal CS
0
   0.0%
1
   0.2%
Musculoskeletal system (week 0) Number Analyzed 544 participants 544 participants
Normal
504
  92.6%
496
  91.2%
Abnormal NCS
36
   6.6%
42
   7.7%
Abnormal CS
4
   0.7%
6
   1.1%
Musculoskeletal system (week 16) Number Analyzed 525 participants 533 participants
Normal
489
  93.1%
494
  92.7%
Abnormal NCS
32
   6.1%
33
   6.2%
Abnormal CS
4
   0.8%
6
   1.1%
Respiratory system (week 0) Number Analyzed 544 participants 544 participants
Normal
535
  98.3%
534
  98.2%
Abnormal NCS
9
   1.7%
9
   1.7%
Abnormal CS
0
   0.0%
1
   0.2%
Respiratory system (week 16) Number Analyzed 525 participants 533 participants
Normal
520
  99.0%
517
  97.0%
Abnormal NCS
5
   1.0%
14
   2.6%
Abnormal CS
0
   0.0%
2
   0.4%
Skin (week 0) Number Analyzed 544 participants 544 participants
Normal
438
  80.5%
429
  78.9%
Abnormal NCS
96
  17.6%
108
  19.9%
Abnormal CS
10
   1.8%
7
   1.3%
Skin (week 16) Number Analyzed 525 participants 533 participants
Normal
418
  79.6%
430
  80.7%
Abnormal NCS
98
  18.7%
98
  18.4%
Abnormal CS
9
   1.7%
5
   0.9%
33.Secondary Outcome
Title Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure
Hide Description Change in vital signs - systolic and diastolic blood pressure from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 525 533
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic blood pressure 0.4  (14.0) -1.2  (14.8)
Diastolic blood pressure -0.4  (8.9) -0.7  (8.9)
34.Secondary Outcome
Title Change From Baseline in Vital Signs: Pulse
Hide Description Change in vital signs - pulse from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 525 533
Mean (Standard Deviation)
Unit of Measure: Beats per min
0.5  (9.0) 0.03  (8.9)
35.Secondary Outcome
Title Change From Baseline in Electrocardiogram (ECG)
Hide Description Changes in electrocardiogram (ECG) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 544 participants 544 participants
Normal
287
  52.8%
270
  49.6%
Abnormal NCS
252
  46.3%
264
  48.5%
Abnormal CS
5
   0.9%
10
   1.8%
Week 16 Number Analyzed 525 participants 533 participants
Normal
274
  52.2%
272
  51.0%
Abnormal NCS
245
  46.7%
253
  47.5%
Abnormal CS
6
   1.1%
8
   1.5%
36.Secondary Outcome
Title Change From Baseline in Fundoscopy/Fundus Photography
Hide Description Changes in fundoscopy/fundus photography from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 544 544
Measure Type: Count of Participants
Unit of Measure: Participants
Left eye (week 0) Number Analyzed 544 participants 543 participants
Normal
225
  41.4%
219
  40.3%
Abnormal NCS
287
  52.8%
297
  54.7%
Abnormal CS
32
   5.9%
27
   5.0%
Left eye (week 16) Number Analyzed 514 participants 516 participants
Normal
205
  39.9%
198
  38.4%
Abnormal NCS
278
  54.1%
288
  55.8%
Abnormal CS
31
   6.0%
30
   5.8%
Right eye (week 0) Number Analyzed 544 participants 544 participants
Normal
224
  41.2%
217
  39.9%
Abnormal NCS
288
  52.9%
300
  55.1%
Abnormal CS
32
   5.9%
27
   5.0%
Right eye (week 16) Number Analyzed 514 participants 517 participants
Normal
208
  40.5%
194
  37.5%
Abnormal NCS
276
  53.7%
297
  57.4%
Abnormal CS
30
   5.8%
26
   5.0%
37.Secondary Outcome
Title Change From Baseline in Haematology - Haematocrit
Hide Description Changes in haematology - haematocrit from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: Percentage
0.48  (2.47) 0.35  (2.47)
38.Secondary Outcome
Title Change From Baseline in Haematology - Haemoglobin
Hide Description Changes in haematology - haemoglobin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.02  (0.47) -0.04  (0.43)
39.Secondary Outcome
Title Change From Baseline in Haematology - Leukocytes
Hide Description Changes in haematology - leukocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: 10^9 leukocytes/L
0.01  (1.60) -0.01  (1.35)
40.Secondary Outcome
Title Change From Baseline in Haematology - Thrombocytes
Hide Description Changes in haematology - thrombocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 531 533
Mean (Standard Deviation)
Unit of Measure: 10^9 thrombocytes/L
-0.9  (37.1) -1.3  (38.7)
41.Secondary Outcome
Title Change From Baseline in Haematology - Erythrocytes
Hide Description Changes in haematology - erythrocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: 10^12 erythrocytes/L
-0.02  (0.28) -0.04  (0.27)
42.Secondary Outcome
Title Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT)
Hide Description Changes in biochemistry - alanine aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: U/L
-0.1  (9.4) 3.1  (65.4)
43.Secondary Outcome
Title Change From Baseline in Biochemistry - Alkaline Phosphatase
Hide Description Changes in biochemistry - alkaline phosphatase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: U/L
2.9  (22.6) 2.2  (18.3)
44.Secondary Outcome
Title Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST)
Hide Description Changes in biochemistry - aspratate aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: U/L
-0.2  (7.9) 2.2  (45.7)
45.Secondary Outcome
Title Change From Baseline in Biochemistry - Albumin
Hide Description Changes in biochemistry - albumin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: g/dL
0.02  (0.25) 0.01  (0.26)
46.Secondary Outcome
Title Change From Baseline in Biochemistry - Creatinine
Hide Description Changes in biochemistry - creatinine from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: umol/L
0.1  (11.1) 1.5  (13.2)
47.Secondary Outcome
Title Change From Baseline in Biochemistry - Potassium
Hide Description Changes in biochemistry - potassium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.001  (0.50) 0.02  (0.43)
48.Secondary Outcome
Title Change From Baseline in Biochemistry - Sodium
Hide Description Changes in biochemistry - sodium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.6  (2.6) -0.7  (2.8)
49.Secondary Outcome
Title Change From Baseline in Biochemistry - Total Bilirubin
Hide Description Changes in biochemistry - total bilirubin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 531 536
Mean (Standard Deviation)
Unit of Measure: umol/L
0.1  (2.7) 0.1  (3.0)
50.Secondary Outcome
Title Change From Baseline in Biochemistry - Total Protein
Hide Description Changes in biochemistry - total protein from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 532 536
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.01  (0.35) -0.02  (0.36)
51.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description Changes in body weight from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
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Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 522 530
Mean (Standard Deviation)
Unit of Measure: kg
1.19  (2.95) 1.12  (4.01)
52.Secondary Outcome
Title Change From Baseline in Body Mass Index (BMI)
Hide Description Change in the body mass index (BMI) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.
Time Frame Week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed = number of participants with available data.
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description:
Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
Overall Number of Participants Analyzed 522 530
Mean (Standard Deviation)
Unit of Measure: kg/m^2
0.43  (1.04) 0.40  (1.40)
Time Frame Week 0 to Week 16 + 7 days. All reported adverse events (AEs) are treatment emergent (i.e., TEAE).
Adverse Event Reporting Description All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants receiving at least one dose of randomised treatment.
 
Arm/Group Title Faster Aspart NovoRapid
Hide Arm/Group Description Participants received Faster aspart along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion. Participants received Insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) along with insulin degludec (basal-bolus regimen) with or without metformin for 16 weeks. Before the treatment period was a 12-week run-in period in which the investigator optimised basal insulin dose. Insulin degludec dose was adjusted weekly by the investigator in the run-in period based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (< 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion.
All-Cause Mortality
Faster Aspart NovoRapid
Affected / at Risk (%) Affected / at Risk (%)
Total   2/544 (0.37%)      1/544 (0.18%)    
Hide Serious Adverse Events
Faster Aspart NovoRapid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/544 (6.99%)      40/544 (7.35%)    
Blood and lymphatic system disorders     
Haemorrhagic anaemia  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Iron deficiency anaemia  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome  1  2/544 (0.37%)  2 0/544 (0.00%)  0
Acute myocardial infarction  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Angina pectoris  1  0/544 (0.00%)  0 2/544 (0.37%)  2
Angina unstable  1  1/544 (0.18%)  1 1/544 (0.18%)  1
Arteriosclerosis coronary artery  1  1/544 (0.18%)  1 1/544 (0.18%)  1
Atrial fibrillation  1  1/544 (0.18%)  1 1/544 (0.18%)  1
Bradycardia  1  1/544 (0.18%)  1 1/544 (0.18%)  1
Cardiac failure  1  2/544 (0.37%)  2 1/544 (0.18%)  1
Cardiac failure congestive  1  0/544 (0.00%)  0 2/544 (0.37%)  2
Coronary artery disease  1  0/544 (0.00%)  0 2/544 (0.37%)  2
Left ventricular failure  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Mitral valve incompetence  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Myocardial ischaemia  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Eye disorders     
Vitreous haemorrhage  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Gastrointestinal disorders     
Colitis  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Cyclic vomiting syndrome  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Diarrhoea  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Duodenal ulcer  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Gastritis erosive  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Obstructive pancreatitis  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Small intestinal obstruction  1  1/544 (0.18%)  1 0/544 (0.00%)  0
General disorders     
Chest pain  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Pain  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Hepatobiliary disorders     
Bile duct obstruction  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Infections and infestations     
Bronchitis  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Device related sepsis  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Gangrene  1  0/544 (0.00%)  0 2/544 (0.37%)  2
Gastroenteritis viral  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Infective exacerbation of chronic obstructive airways disease  1  0/544 (0.00%)  0 1/544 (0.18%)  2
Lower respiratory tract infection  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Orchitis  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Osteomyelitis  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Pneumonia  1  2/544 (0.37%)  2 1/544 (0.18%)  1
Respiratory tract infection  1  0/544 (0.00%)  0 2/544 (0.37%)  2
Upper respiratory tract infection  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental overdose  1  2/544 (0.37%)  2 0/544 (0.00%)  0
Contusion  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Fall  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Fibula fracture  1  1/544 (0.18%)  1 1/544 (0.18%)  1
Humerus fracture  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Road traffic accident  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Wrong product administered  1  1/544 (0.18%)  1 1/544 (0.18%)  1
Investigations     
Cardiac stress test abnormal  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Hyperglycaemia  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Hypoglycaemia  1  4/544 (0.74%)  4 3/544 (0.55%)  3
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Lumbar spinal stenosis  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Spinal pain  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Trigger finger  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Hepatocellular carcinoma  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Invasive ductal breast carcinoma  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Lung neoplasm malignant  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Pancreatic carcinoma metastatic  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Nervous system disorders     
Cerebellar infarction  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Diabetic neuropathy  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Dizziness  1  0/544 (0.00%)  0 2/544 (0.37%)  2
Encephalopathy  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Haemorrhagic stroke  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Headache  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Hypoglycaemic unconsciousness  1  3/544 (0.55%)  3 0/544 (0.00%)  0
Transient ischaemic attack  1  2/544 (0.37%)  2 1/544 (0.18%)  1
Vascular parkinsonism  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Product Issues     
Device malfunction  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Psychiatric disorders     
Delusion  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Rapid eye movements sleep abnormal  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Renal failure  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/544 (0.00%)  0 2/544 (0.37%)  2
Pulmonary oedema  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Respiratory failure  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Surgical and medical procedures     
Aortic valve replacement  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Carpal tunnel decompression  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Rehabilitation therapy  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Vitrectomy  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Vascular disorders     
Aortic aneurysm  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Deep vein thrombosis  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Hypotension  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Peripheral vascular disorder  1  1/544 (0.18%)  1 0/544 (0.00%)  0
Subclavian vein occlusion  1  0/544 (0.00%)  0 1/544 (0.18%)  1
Varicose ulceration  1  0/544 (0.00%)  0 1/544 (0.18%)  1
1
Term from vocabulary, MedDRA 21
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Faster Aspart NovoRapid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/544 (5.88%)      33/544 (6.07%)    
Infections and infestations     
Nasopharyngitis  1  32/544 (5.88%)  35 33/544 (6.07%)  36
1
Term from vocabulary, MedDRA 21
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: NCT03268005    
Other Study ID Numbers: NN1218-4113
U1111-1180-0636 ( Other Identifier: World Health Organization (WHO) )
2016-000878-38 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Submitted: August 29, 2017
First Posted: August 31, 2017
Results First Submitted: January 7, 2020
Results First Posted: February 5, 2020
Last Update Posted: April 8, 2020