onset 9: Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes
Study Details
Study Description
Brief Summary
The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Faster aspart + insulin degludec with or without metformin
|
Drug: Faster-acting insulin aspart
Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
Drug: Insulin degludec
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
Drug: Metformin
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
|
Active Comparator: NovoRapid/NovoLog + insulin degludec with or without metformin
|
Drug: Insulin aspart
Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
Drug: Insulin degludec
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
Drug: Metformin
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
|
Outcome Measures
Primary Outcome Measures
- Change in Glycosylated Haemoglobin (HbA1c) [Week 0, week 16]
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.
Secondary Outcome Measures
- Change From Baseline in 1-hour PPG Increment [Week 0, week 16]
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.
- Change From Baseline in 1,5-anhydroglucitol [Week 0, week 16]
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.
- Change From Baseline in Fasting Plasma Glucose (FPG) [Week 0, week 16]
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.
- Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No) [16 weeks after randomisation]
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.
- Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No) [16 weeks after randomisation]
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.
- Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) [Week 0, week 16]
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.
- Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) [Week 0, week 16]
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.
- Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile [Week 0, week 16]
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.
- Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) [Week 0, week 16]
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.
- Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) [Week 0, week 16]
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.
- Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile [Week 0, week 16]
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.
- Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements [Week 0, week 16]
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.
- Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No) [16 weeks after randomisation]
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.
- Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No) [16 weeks after randomisation]
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.
- Total Bolus Insulin Dose: in Units/Day [16 weeks from randomisation]
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.
- Total Bolus Insulin Dose: in Units/kg/Day [16 weeks from randomisation]
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.
- Total Basal Insulin Dose: in Units/Day [16 weeks from randomisation]
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.
- Total Basal Insulin Dose: in Units/kg/Day [16 weeks from randomisation]
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.
- Individual Meal Insulin Dose: in Units [16 weeks from randomisation]
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.
- Individual Meal Insulin Dose: in Units/kg [16 weeks from randomisation]
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.
- Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline [Week 0, week 16]
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.
- Number of Treatment Emergent Adverse Events [Weeks 0-16]
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.
- Number of Treatment Emergent Injection Site Reactions [Weeks 0-16]
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.
- Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall [Weeks 0-16]
ADA classification of hypos: 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. Documented symptomatic: PG ≤3.9 mmol/L with symptoms. Asymptomatic: PG ≤3.9 mmol/L without symptoms. Probable symptomatic: No measurement with symptoms. Pseudo: PG >3.9 mmol/L with symptoms. Unclassifiable. NN classification of hypos: BG confirmed: PG <3.1 mmol/L with/without symptoms. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia.
- Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) [Weeks 0-16]
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.
- Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) [Weeks 0-16]
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.
- 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 [Weeks 0-16]
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.
- 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 [Weeks 0-16]
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.
- 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 [Weeks 0-16]
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.
- 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 [Weeks 0-16]
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.
- Change From Baseline in Physical Examination [Week 0, week 16]
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
- Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure [Week 0, week 16]
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.
- Change From Baseline in Vital Signs: Pulse [Week 0, week 16]
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.
- Change From Baseline in Electrocardiogram (ECG) [Week 0, week 16]
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.
- Change From Baseline in Fundoscopy/Fundus Photography [Week 0, week 16]
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.
- Change From Baseline in Haematology - Haematocrit [Week 0, week 16]
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.
- Change From Baseline in Haematology - Haemoglobin [Week 0, week 16]
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.
- Change From Baseline in Haematology - Leukocytes [Week 0, week 16]
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.
- Change From Baseline in Haematology - Thrombocytes [Week 0, week 16]
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.
- Change From Baseline in Haematology - Erythrocytes [Week 0, week 16]
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.
- Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT) [Week 0, week 16]
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.
- Change From Baseline in Biochemistry - Alkaline Phosphatase [Week 0, week 16]
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.
- Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST) [Week 0, week 16]
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.
- Change From Baseline in Biochemistry - Albumin [Week 0, week 16]
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.
- Change From Baseline in Biochemistry - Creatinine [Week 0, week 16]
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.
- Change From Baseline in Biochemistry - Potassium [Week 0, week 16]
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.
- Change From Baseline in Biochemistry - Sodium [Week 0, week 16]
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.
- Change From Baseline in Biochemistry - Total Bilirubin [Week 0, week 16]
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.
- Change From Baseline in Biochemistry - Total Protein [Week 0, week 16]
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.
- Change From Baseline in Body Weight [Week 0, week 16]
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.
- Change From Baseline in Body Mass Index (BMI) [Week 0, week 16]
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.
Eligibility Criteria
Criteria
Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1). Exclusion Criteria: - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1). - Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1). - Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novo Nordisk Investigational Site | Concord | California | United States | 94520 |
2 | Novo Nordisk Investigational Site | Fresno | California | United States | 93720 |
3 | Novo Nordisk Investigational Site | Fullerton | California | United States | 92835 |
4 | Novo Nordisk Investigational Site | Lancaster | California | United States | 93534 |
5 | Novo Nordisk Investigational Site | Norco | California | United States | 92860 |
6 | Novo Nordisk Investigational Site | Sacramento | California | United States | 95821 |
7 | Novo Nordisk Investigational Site | Ventura | California | United States | 93003 |
8 | Novo Nordisk Investigational Site | Walnut Creek | California | United States | 94598 |
9 | Novo Nordisk Investigational Site | Denver | Colorado | United States | 80246 |
10 | Novo Nordisk Investigational Site | Golden | Colorado | United States | 80401 |
11 | Novo Nordisk Investigational Site | Waterbury | Connecticut | United States | 06708 |
12 | Novo Nordisk Investigational Site | Boynton Beach | Florida | United States | 33472 |
13 | Novo Nordisk Investigational Site | Bradenton | Florida | United States | 34201 |
14 | Novo Nordisk Investigational Site | Fort Lauderdale | Florida | United States | 33312 |
15 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33174 |
16 | Novo Nordisk Investigational Site | Tampa | Florida | United States | 33634 |
17 | Novo Nordisk Investigational Site | Alpharetta | Georgia | United States | 30022 |
18 | Novo Nordisk Investigational Site | Lawrenceville | Georgia | United States | 30046 |
19 | Novo Nordisk Investigational Site | Roswell | Georgia | United States | 30076 |
20 | Novo Nordisk Investigational Site | Honolulu | Hawaii | United States | 96814 |
21 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60611 |
22 | Novo Nordisk Investigational Site | Peoria | Illinois | United States | 61603 |
23 | Novo Nordisk Investigational Site | Springfield | Illinois | United States | 62711 |
24 | Novo Nordisk Investigational Site | Valparaiso | Indiana | United States | 46383 |
25 | Novo Nordisk Investigational Site | West Des Moines | Iowa | United States | 50266 |
26 | Novo Nordisk Investigational Site | Topeka | Kansas | United States | 66606 |
27 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40502 |
28 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40503 |
29 | Novo Nordisk Investigational Site | Rockville | Maryland | United States | 20852 |
30 | Novo Nordisk Investigational Site | Waltham | Massachusetts | United States | 02453 |
31 | Novo Nordisk Investigational Site | Worcester | Massachusetts | United States | 01655 |
32 | Novo Nordisk Investigational Site | Henderson | Nevada | United States | 89052-2649 |
33 | Novo Nordisk Investigational Site | Las Vegas | Nevada | United States | 89148 |
34 | Novo Nordisk Investigational Site | Nashua | New Hampshire | United States | 03063 |
35 | Novo Nordisk Investigational Site | Northport | New York | United States | 11768 |
36 | Novo Nordisk Investigational Site | West Seneca | New York | United States | 14224 |
37 | Novo Nordisk Investigational Site | Asheville | North Carolina | United States | 28803 |
38 | Novo Nordisk Investigational Site | Chapel Hill | North Carolina | United States | 27514 |
39 | Novo Nordisk Investigational Site | Mentor | Ohio | United States | 44060 |
40 | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | United States | 73104-5020 |
41 | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | United States | 19140 |
42 | Novo Nordisk Investigational Site | Greenville | South Carolina | United States | 29605-4254 |
43 | Novo Nordisk Investigational Site | Chattanooga | Tennessee | United States | 37404 |
44 | Novo Nordisk Investigational Site | Chattanooga | Tennessee | United States | 37411 |
45 | Novo Nordisk Investigational Site | Nashville | Tennessee | United States | 37212 |
46 | Novo Nordisk Investigational Site | Amarillo | Texas | United States | 79106 |
47 | Novo Nordisk Investigational Site | Austin | Texas | United States | 78731 |
48 | Novo Nordisk Investigational Site | Austin | Texas | United States | 78749 |
49 | Novo Nordisk Investigational Site | Beaumont | Texas | United States | 77701 |
50 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75226 |
51 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75230 |
52 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75231 |
53 | Novo Nordisk Investigational Site | Longview | Texas | United States | 75605 |
54 | Novo Nordisk Investigational Site | Pearland | Texas | United States | 77584 |
55 | Novo Nordisk Investigational Site | Round Rock | Texas | United States | 78681 |
56 | Novo Nordisk Investigational Site | Ogden | Utah | United States | 84405 |
57 | Novo Nordisk Investigational Site | Bennington | Vermont | United States | 05201 |
58 | Novo Nordisk Investigational Site | South Burlington | Vermont | United States | 05403 |
59 | Novo Nordisk Investigational Site | Chesapeake | Virginia | United States | 23321 |
60 | Novo Nordisk Investigational Site | Winchester | Virginia | United States | 22601-3834 |
61 | Novo Nordisk Investigational Site | Olympia | Washington | United States | 98502 |
62 | Novo Nordisk Investigational Site | Seattle | Washington | United States | 98105 |
63 | Novo Nordisk Investigational Site | Spokane | Washington | United States | 99201 |
64 | Novo Nordisk Investigational Site | Green Bay | Wisconsin | United States | 54303 |
65 | Novo Nordisk Investigational Site | Caba | Argentina | C1060ABA | |
66 | Novo Nordisk Investigational Site | Caba | Argentina | C1440AAD | |
67 | Novo Nordisk Investigational Site | Cordoba | Argentina | 5000 | |
68 | Novo Nordisk Investigational Site | Córdoba | Argentina | 5008 | |
69 | Novo Nordisk Investigational Site | Kozloduy | Bulgaria | 3320 | |
70 | Novo Nordisk Investigational Site | Razgrad | Bulgaria | 7200 | |
71 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1233 | |
72 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1618 | |
73 | Novo Nordisk Investigational Site | Edmonton | Alberta | Canada | T6G 2E1 |
74 | Novo Nordisk Investigational Site | Victoria | British Columbia | Canada | V8V 4A1 |
75 | Novo Nordisk Investigational Site | Halifax | Nova Scotia | Canada | B3H 2Y9 |
76 | Novo Nordisk Investigational Site | Barrie | Ontario | Canada | L4N 7L3 |
77 | Novo Nordisk Investigational Site | Concord | Ontario | Canada | L4K 4M2 |
78 | Novo Nordisk Investigational Site | Etobicoke | Ontario | Canada | M9R 4E1 |
79 | Novo Nordisk Investigational Site | Hamilton | Ontario | Canada | L8M 1K7 |
80 | Novo Nordisk Investigational Site | Newmarket | Ontario | Canada | L3Y 5G8 |
81 | Novo Nordisk Investigational Site | Thunder Bay | Ontario | Canada | P7A 4V7 |
82 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M4G 3E8 |
83 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H4T 1Z9 |
84 | Novo Nordisk Investigational Site | Karlovac | Croatia | 47000 | |
85 | Novo Nordisk Investigational Site | Osijek | Croatia | 31 000 | |
86 | Novo Nordisk Investigational Site | Varazdin | Croatia | 42 000 | |
87 | Novo Nordisk Investigational Site | Zagreb | Croatia | 10 000 | |
88 | Novo Nordisk Investigational Site | Hradec Kralove | Czechia | 500 05 | |
89 | Novo Nordisk Investigational Site | Plzen | Czechia | 30100 | |
90 | Novo Nordisk Investigational Site | Plzen | Czechia | 32600 | |
91 | Novo Nordisk Investigational Site | Trutnov | Czechia | 541 01 | |
92 | Novo Nordisk Investigational Site | Dresden | Germany | 01219 | |
93 | Novo Nordisk Investigational Site | Essen | Germany | 45136 | |
94 | Novo Nordisk Investigational Site | Falkensee | Germany | 14612 | |
95 | Novo Nordisk Investigational Site | Lingen | Germany | 49808 | |
96 | Novo Nordisk Investigational Site | Münster | Germany | 48145 | |
97 | Novo Nordisk Investigational Site | Saint Ingbert-Oberwürzbach | Germany | 66386 | |
98 | Novo Nordisk Investigational Site | Schweinfurt | Germany | 97421 | |
99 | Novo Nordisk Investigational Site | Athens | Greece | 115 25 | |
100 | Novo Nordisk Investigational Site | Athens | Greece | GR-11527 | |
101 | Novo Nordisk Investigational Site | Ioannina | Greece | 45500 | |
102 | Novo Nordisk Investigational Site | Larissa | Greece | GR-41110 | |
103 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-54636 | |
104 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-54642 | |
105 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-54643 | |
106 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-57001 | |
107 | Novo Nordisk Investigational Site | Catanzaro | Italy | 88100 | |
108 | Novo Nordisk Investigational Site | Chieti | Italy | 66100 | |
109 | Novo Nordisk Investigational Site | Cittadella (PD) | Italy | 35013 | |
110 | Novo Nordisk Investigational Site | Milano (MI) | Italy | 20132 | |
111 | Novo Nordisk Investigational Site | Olbia | Italy | 07026 | |
112 | Novo Nordisk Investigational Site | Palermo | Italy | 90129 | |
113 | Novo Nordisk Investigational Site | Bucheon | Korea, Republic of | 14647 | |
114 | Novo Nordisk Investigational Site | Daegu | Korea, Republic of | 42472 | |
115 | Novo Nordisk Investigational Site | Seongnam-si | Korea, Republic of | 463-707 | |
116 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 02447 | |
117 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 03080 | |
118 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 04516 | |
119 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 06351 | |
120 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 08308 | |
121 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 137-701 | |
122 | Novo Nordisk Investigational Site | Wonju | Korea, Republic of | 26426 | |
123 | Novo Nordisk Investigational Site | Bialystok | Poland | 15-435 | |
124 | Novo Nordisk Investigational Site | Skorzewo | Poland | 60-185 | |
125 | Novo Nordisk Investigational Site | Warsaw | Poland | 00-465 | |
126 | Novo Nordisk Investigational Site | Warsaw | Poland | 02-793 | |
127 | Novo Nordisk Investigational Site | Warszawa | Poland | 02-507 | |
128 | Novo Nordisk Investigational Site | Wroclaw | Poland | 50-381 | |
129 | Novo Nordisk Investigational Site | Ponce | Puerto Rico | 00716 | |
130 | Novo Nordisk Investigational Site | Baia Mare | Maramures | Romania | 430222 |
131 | Novo Nordisk Investigational Site | Tirgu Mures | Mures | Romania | 540142 |
132 | Novo Nordisk Investigational Site | Timisoara | Timis | Romania | 300125 |
133 | Novo Nordisk Investigational Site | Brasov | Romania | 500101 | |
134 | Novo Nordisk Investigational Site | Brasov | Romania | 500283 | |
135 | Novo Nordisk Investigational Site | Bucharest | Romania | 13682 | |
136 | Novo Nordisk Investigational Site | Arkhangelsk | Russian Federation | 163045 | |
137 | Novo Nordisk Investigational Site | Kazan | Russian Federation | 420073 | |
138 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 123448 | |
139 | Novo Nordisk Investigational Site | Penza | Russian Federation | 440026 | |
140 | Novo Nordisk Investigational Site | Saint Petersburg | Russian Federation | 194291 | |
141 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 194356 | |
142 | Novo Nordisk Investigational Site | Tumen | Russian Federation | 625023 | |
143 | Novo Nordisk Investigational Site | Voronezh | Russian Federation | 394018 | |
144 | Novo Nordisk Investigational Site | Belgrade | Serbia | 11000 | |
145 | Novo Nordisk Investigational Site | Kragujevac | Serbia | 34000 | |
146 | Novo Nordisk Investigational Site | Nis | Serbia | 18000 | |
147 | Novo Nordisk Investigational Site | Novi Sad | Serbia | 21000 | |
148 | Novo Nordisk Investigational Site | Zajecar | Serbia | 19000 | |
149 | Novo Nordisk Investigational Site | Kosice | Slovakia | 040 01 | |
150 | Novo Nordisk Investigational Site | Kysucke Nove Mesto | Slovakia | 024 01 | |
151 | Novo Nordisk Investigational Site | Lubochna | Slovakia | 03491 | |
152 | Novo Nordisk Investigational Site | Lucenec | Slovakia | 984 01 | |
153 | Novo Nordisk Investigational Site | Zilina | Slovakia | 01001 | |
154 | Novo Nordisk Investigational Site | Alcobendas | Spain | 28100 | |
155 | Novo Nordisk Investigational Site | Almería | Spain | 04001 | |
156 | Novo Nordisk Investigational Site | Girona | Spain | 17007 | |
157 | Novo Nordisk Investigational Site | La Coruña | Spain | 15006 | |
158 | Novo Nordisk Investigational Site | Pozuelo de Alarcon | Spain | 28223 | |
159 | Novo Nordisk Investigational Site | Sabadell | Spain | 08208 | |
160 | Novo Nordisk Investigational Site | Sevilla | Spain | 41003 | |
161 | Novo Nordisk Investigational Site | Sevilla | Spain | 41010 | |
162 | Novo Nordisk Investigational Site | Dnipro | Ukraine | 49038 | |
163 | Novo Nordisk Investigational Site | Kharkiv | Ukraine | 61000 | |
164 | Novo Nordisk Investigational Site | Kyiv | Ukraine | 03049 | |
165 | Novo Nordisk Investigational Site | Lviv | Ukraine | 79010 | |
166 | Novo Nordisk Investigational Site | Ternopil | Ukraine | 46002 | |
167 | Novo Nordisk Investigational Site | Vinnytsia | Ukraine | 21010 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- NN1218-4113
- U1111-1180-0636
- 2016-000878-38
Study Results
Participant Flow
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 Detail | 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 |
---|---|---|
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 |
Baseline Characteristics
Arm/Group Title | Faster Aspart | NovoRapid | Total |
---|---|---|---|
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 Participants | 546 | 545 | 1091 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
62.6
(8.6)
|
62.1
(8.8)
|
62.3
(8.7)
|
Sex: Female, Male (Count of Participants) | |||
Female |
281
51.5%
|
256
47%
|
537
49.2%
|
Male |
265
48.5%
|
289
53%
|
554
50.8%
|
Race/Ethnicity, Customized (Count of 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%
|
Native Hawaiian or Other Pacific Islander |
2
0.4%
|
5
0.9%
|
7
0.6%
|
Other |
0
0%
|
3
0.6%
|
3
0.3%
|
Race/Ethnicity, Customized (Count of 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%
|
Outcome Measures
Title | Change in Glycosylated Haemoglobin (HbA1c) |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 544 | 539 |
Mean (Standard Deviation) [Percentage of HbA1c] |
-0.15
(0.62)
|
-0.09
(0.60)
|
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 | ||
Method | ANOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Treatment difference |
Estimated Value | -0.04 | |
Confidence Interval |
(2-Sided) 95% -0.11 to 0.03 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Faster aspart-NovoRapid |
Title | Change From Baseline in 1-hour PPG Increment |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 519 | 523 |
Mean (Standard Deviation) [mmol/L] |
-0.43
(2.45)
|
0.08
(2.65)
|
Title | Change From Baseline in 1,5-anhydroglucitol |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 534 | 531 |
Mean (Standard Deviation) [mmol/L] |
1.38
(3.10)
|
0.89
(3.31)
|
Title | Change From Baseline in Fasting Plasma Glucose (FPG) |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 533 | 530 |
Mean (Standard Deviation) [mmol/L] |
0.56
(2.38)
|
0.68
(2.40)
|
Title | Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 546 | 545 |
Yes |
271
49.6%
|
282
51.7%
|
No |
275
50.4%
|
263
48.3%
|
Title | Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 546 | 545 |
Yes |
265
48.5%
|
278
51%
|
No |
281
51.5%
|
267
49%
|
Title | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 546 | 545 |
30-min |
0.31
(2.90)
|
0.55
(2.80)
|
1-hour |
0.03
(3.30)
|
0.68
(3.23)
|
2-hour |
0.08
(3.96)
|
0.61
(3.48)
|
3-hour |
0.30
(3.85)
|
0.89
(3.72)
|
4-hour |
0.51
(3.47)
|
0.75
(3.51)
|
Title | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 546 | 545 |
30-min |
-0.13
(1.85)
|
-0.05
(1.95)
|
1-hour |
-0.43
(2.45)
|
0.08
(2.65)
|
2-hour |
-0.37
(3.25)
|
0.001
(3.13)
|
3-hour |
-0.15
(3.23)
|
0.28
(3.54)
|
4-hour |
0.04
(3.00)
|
0.15
(3.45)
|
Title | Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 454 | 464 |
Mean (Standard Deviation) [mmol/L] |
-0.56
(1.66)
|
-0.50
(1.61)
|
Title | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 546 | 545 |
Breakfast |
-0.38
(2.53)
|
-0.28
(2.44)
|
Lunch |
-0.78
(2.48)
|
-0.58
(2.68)
|
Main evening meal |
-1.04
(2.67)
|
-0.71
(2.50)
|
All meals |
-0.75
(1.89)
|
-0.52
(1.91)
|
Title | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 546 | 545 |
Breakfast |
-0.56
(2.23)
|
-0.42
(2.17)
|
Lunch |
-0.38
(2.69)
|
-0.23
(2.46)
|
Main evening meal |
-0.44
(2.61)
|
-0.10
(2.28)
|
All meals |
-0.48
(1.55)
|
-0.23
(1.42)
|
Title | Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 454 | 464 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio] |
0.82
(48.32)
|
0.85
(55.06)
|
Title | Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 546 | 545 |
Bedtime to 04:00 |
0.70
(4.09)
|
0.29
(4.09)
|
Bedtime to breakfast |
1.30
(4.25)
|
0.90
(3.99)
|
04:00 to breakfast |
0.66
(2.76)
|
0.75
(2.87)
|
Title | Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 546 | 545 |
Yes |
186
34.1%
|
192
35.2%
|
No |
360
65.9%
|
353
64.8%
|
Title | Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 546 | 545 |
Yes |
182
33.3%
|
190
34.9%
|
No |
364
66.7%
|
355
65.1%
|
Title | Total Bolus Insulin Dose: in Units/Day |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 544 | 542 |
Mean (Standard Deviation) [Units/day] |
54.72
(35.82)
|
53.38
(35.35)
|
Title | Total Bolus Insulin Dose: in Units/kg/Day |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 544 | 542 |
Mean (Standard Deviation) [Units/kg/day] |
0.57
(0.33)
|
0.55
(0.34)
|
Title | Total Basal Insulin Dose: in Units/Day |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 544 | 542 |
Mean (Standard Deviation) [Units/day] |
63.76
(35.21)
|
62.25
(36.03)
|
Title | Total Basal Insulin Dose: in Units/kg/Day |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 544 | 542 |
Mean (Standard Deviation) [Units/kg/day] |
0.66
(0.32)
|
0.64
(0.32)
|
Title | Individual Meal Insulin Dose: in Units |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
Breakfast |
16.27
(12.04)
|
15.52
(11.38)
|
Lunch |
18.51
(12.09)
|
17.96
(11.73)
|
Daily main evening meal |
19.88
(13.46)
|
19.85
(14.47)
|
Title | Individual Meal Insulin Dose: in Units/kg |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
Breakfast |
0.17
(0.12)
|
0.16
(0.11)
|
Lunch |
0.19
(0.11)
|
0.19
(0.12)
|
Daily main evening meal |
0.21
(0.13)
|
0.20
(0.14)
|
Title | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 546 | 545 |
Total cholesterol |
1.01
(15.98)
|
1.00
(17.09)
|
High density lipoproteins |
0.97
(14.47)
|
0.98
(17.57)
|
Low density lipoproteins |
0.99
(25.36)
|
0.99
(40.51)
|
Title | Number of Treatment Emergent Adverse Events |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 544 | 544 |
Number [Events] |
667
|
643
|
Title | Number of Treatment Emergent Injection Site Reactions |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 544 | 544 |
Number [Number of injection site reactions] |
3
|
1
|
Title | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall |
---|---|
Description | ADA classification of hypos: 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. Documented symptomatic: PG ≤3.9 mmol/L with symptoms. Asymptomatic: PG ≤3.9 mmol/L without symptoms. Probable symptomatic: No measurement with symptoms. Pseudo: PG >3.9 mmol/L with symptoms. Unclassifiable. NN classification of hypos: BG confirmed: PG <3.1 mmol/L with/without symptoms. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia. |
Time Frame | Weeks 0-16 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
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
|
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) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
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
|
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) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
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
|
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 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
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
|
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 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
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
|
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 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
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
|
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 |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
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
|
Title | Change From Baseline in Physical Examination |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
Normal |
459
84.1%
|
460
84.4%
|
Abnormal NCS |
79
14.5%
|
79
14.5%
|
Abnormal CS |
6
1.1%
|
5
0.9%
|
Normal |
448
82.1%
|
457
83.9%
|
Abnormal NCS |
71
13%
|
72
13.2%
|
Abnormal CS |
6
1.1%
|
4
0.7%
|
Normal |
398
72.9%
|
404
74.1%
|
Abnormal NCS |
133
24.4%
|
127
23.3%
|
Abnormal CS |
13
2.4%
|
13
2.4%
|
Normal |
383
70.1%
|
400
73.4%
|
Abnormal NCS |
128
23.4%
|
122
22.4%
|
Abnormal CS |
14
2.6%
|
11
2%
|
Normal |
491
89.9%
|
485
89%
|
Abnormal NCS |
53
9.7%
|
59
10.8%
|
Abnormal CS |
0
0%
|
0
0%
|
Normal |
480
87.9%
|
476
87.3%
|
Abnormal NCS |
45
8.2%
|
57
10.5%
|
Abnormal CS |
0
0%
|
0
0%
|
Normal |
498
91.2%
|
492
90.3%
|
Abnormal NCS |
43
7.9%
|
48
8.8%
|
Abnormal CS |
3
0.5%
|
4
0.7%
|
Normal |
485
88.8%
|
483
88.6%
|
Abnormal NCS |
40
7.3%
|
49
9%
|
Abnormal CS |
0
0%
|
1
0.2%
|
Normal |
504
92.3%
|
496
91%
|
Abnormal NCS |
36
6.6%
|
42
7.7%
|
Abnormal CS |
4
0.7%
|
6
1.1%
|
Normal |
489
89.6%
|
494
90.6%
|
Abnormal NCS |
32
5.9%
|
33
6.1%
|
Abnormal CS |
4
0.7%
|
6
1.1%
|
Normal |
535
98%
|
534
98%
|
Abnormal NCS |
9
1.6%
|
9
1.7%
|
Abnormal CS |
0
0%
|
1
0.2%
|
Normal |
520
95.2%
|
517
94.9%
|
Abnormal NCS |
5
0.9%
|
14
2.6%
|
Abnormal CS |
0
0%
|
2
0.4%
|
Normal |
438
80.2%
|
429
78.7%
|
Abnormal NCS |
96
17.6%
|
108
19.8%
|
Abnormal CS |
10
1.8%
|
7
1.3%
|
Normal |
418
76.6%
|
430
78.9%
|
Abnormal NCS |
98
17.9%
|
98
18%
|
Abnormal CS |
9
1.6%
|
5
0.9%
|
Title | Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 525 | 533 |
Systolic blood pressure |
0.4
(14.0)
|
-1.2
(14.8)
|
Diastolic blood pressure |
-0.4
(8.9)
|
-0.7
(8.9)
|
Title | Change From Baseline in Vital Signs: Pulse |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 525 | 533 |
Mean (Standard Deviation) [Beats per min] |
0.5
(9.0)
|
0.03
(8.9)
|
Title | Change From Baseline in Electrocardiogram (ECG) |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
Normal |
287
52.6%
|
270
49.5%
|
Abnormal NCS |
252
46.2%
|
264
48.4%
|
Abnormal CS |
5
0.9%
|
10
1.8%
|
Normal |
274
50.2%
|
272
49.9%
|
Abnormal NCS |
245
44.9%
|
253
46.4%
|
Abnormal CS |
6
1.1%
|
8
1.5%
|
Title | Change From Baseline in Fundoscopy/Fundus Photography |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|
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. |
Measure Participants | 544 | 544 |
Normal |
225
41.2%
|
219
40.2%
|
Abnormal NCS |
287
52.6%
|
297
54.5%
|
Abnormal CS |
32
5.9%
|
27
5%
|
Normal |
205
37.5%
|
198
36.3%
|
Abnormal NCS |
278
50.9%
|
288
52.8%
|
Abnormal CS |
31
5.7%
|
30
5.5%
|
Normal |
224
41%
|
217
39.8%
|
Abnormal NCS |
288
52.7%
|
300
55%
|
Abnormal CS |
32
5.9%
|
27
5%
|
Normal |
208
38.1%
|
194
35.6%
|
Abnormal NCS |
276
50.5%
|
297
54.5%
|
Abnormal CS |
30
5.5%
|
26
4.8%
|
Title | Change From Baseline in Haematology - Haematocrit |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [Percentage] |
0.48
(2.47)
|
0.35
(2.47)
|
Title | Change From Baseline in Haematology - Haemoglobin |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [mmol/L] |
-0.02
(0.47)
|
-0.04
(0.43)
|
Title | Change From Baseline in Haematology - Leukocytes |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [10^9 leukocytes/L] |
0.01
(1.60)
|
-0.01
(1.35)
|
Title | Change From Baseline in Haematology - Thrombocytes |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 531 | 533 |
Mean (Standard Deviation) [10^9 thrombocytes/L] |
-0.9
(37.1)
|
-1.3
(38.7)
|
Title | Change From Baseline in Haematology - Erythrocytes |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [10^12 erythrocytes/L] |
-0.02
(0.28)
|
-0.04
(0.27)
|
Title | Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT) |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [U/L] |
-0.1
(9.4)
|
3.1
(65.4)
|
Title | Change From Baseline in Biochemistry - Alkaline Phosphatase |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [U/L] |
2.9
(22.6)
|
2.2
(18.3)
|
Title | Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST) |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [U/L] |
-0.2
(7.9)
|
2.2
(45.7)
|
Title | Change From Baseline in Biochemistry - Albumin |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [g/dL] |
0.02
(0.25)
|
0.01
(0.26)
|
Title | Change From Baseline in Biochemistry - Creatinine |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [umol/L] |
0.1
(11.1)
|
1.5
(13.2)
|
Title | Change From Baseline in Biochemistry - Potassium |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [mmol/L] |
-0.001
(0.50)
|
0.02
(0.43)
|
Title | Change From Baseline in Biochemistry - Sodium |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [mmol/L] |
-0.6
(2.6)
|
-0.7
(2.8)
|
Title | Change From Baseline in Biochemistry - Total Bilirubin |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 531 | 536 |
Mean (Standard Deviation) [umol/L] |
0.1
(2.7)
|
0.1
(3.0)
|
Title | Change From Baseline in Biochemistry - Total Protein |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 532 | 536 |
Mean (Standard Deviation) [g/dL] |
-0.01
(0.35)
|
-0.02
(0.36)
|
Title | Change From Baseline in Body Weight |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 522 | 530 |
Mean (Standard Deviation) [kg] |
1.19
(2.95)
|
1.12
(4.01)
|
Title | Change From Baseline in Body Mass Index (BMI) |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Overall number of participants analyzed = number of participants with available data. |
Arm/Group Title | Faster Aspart | NovoRapid |
---|---|---|
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. |
Measure Participants | 522 | 530 |
Mean (Standard Deviation) [kg/m^2] |
0.43
(1.04)
|
0.40
(1.40)
|
Adverse Events
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 | ||
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 (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/544 (0.4%) | 1/544 (0.2%) | ||
Serious Adverse Events |
||||
Faster Aspart | NovoRapid | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 38/544 (7%) | 40/544 (7.4%) | ||
Blood and lymphatic system disorders | ||||
Haemorrhagic anaemia | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Iron deficiency anaemia | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Cardiac disorders | ||||
Acute coronary syndrome | 2/544 (0.4%) | 2 | 0/544 (0%) | 0 |
Acute myocardial infarction | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Angina pectoris | 0/544 (0%) | 0 | 2/544 (0.4%) | 2 |
Angina unstable | 1/544 (0.2%) | 1 | 1/544 (0.2%) | 1 |
Arteriosclerosis coronary artery | 1/544 (0.2%) | 1 | 1/544 (0.2%) | 1 |
Atrial fibrillation | 1/544 (0.2%) | 1 | 1/544 (0.2%) | 1 |
Bradycardia | 1/544 (0.2%) | 1 | 1/544 (0.2%) | 1 |
Cardiac failure | 2/544 (0.4%) | 2 | 1/544 (0.2%) | 1 |
Cardiac failure congestive | 0/544 (0%) | 0 | 2/544 (0.4%) | 2 |
Coronary artery disease | 0/544 (0%) | 0 | 2/544 (0.4%) | 2 |
Left ventricular failure | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Mitral valve incompetence | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Myocardial ischaemia | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Eye disorders | ||||
Vitreous haemorrhage | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Gastrointestinal disorders | ||||
Colitis | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Cyclic vomiting syndrome | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Diarrhoea | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Duodenal ulcer | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Gastritis erosive | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Obstructive pancreatitis | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Small intestinal obstruction | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
General disorders | ||||
Chest pain | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Pain | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Hepatobiliary disorders | ||||
Bile duct obstruction | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Infections and infestations | ||||
Bronchitis | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Device related sepsis | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Gangrene | 0/544 (0%) | 0 | 2/544 (0.4%) | 2 |
Gastroenteritis viral | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Infective exacerbation of chronic obstructive airways disease | 0/544 (0%) | 0 | 1/544 (0.2%) | 2 |
Lower respiratory tract infection | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Orchitis | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Osteomyelitis | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Pneumonia | 2/544 (0.4%) | 2 | 1/544 (0.2%) | 1 |
Respiratory tract infection | 0/544 (0%) | 0 | 2/544 (0.4%) | 2 |
Upper respiratory tract infection | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Injury, poisoning and procedural complications | ||||
Accidental overdose | 2/544 (0.4%) | 2 | 0/544 (0%) | 0 |
Contusion | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Fall | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Fibula fracture | 1/544 (0.2%) | 1 | 1/544 (0.2%) | 1 |
Humerus fracture | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Road traffic accident | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Wrong product administered | 1/544 (0.2%) | 1 | 1/544 (0.2%) | 1 |
Investigations | ||||
Cardiac stress test abnormal | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Metabolism and nutrition disorders | ||||
Dehydration | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Hyperglycaemia | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Hypoglycaemia | 4/544 (0.7%) | 4 | 3/544 (0.6%) | 3 |
Musculoskeletal and connective tissue disorders | ||||
Arthritis | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Lumbar spinal stenosis | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Spinal pain | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Trigger finger | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Adenocarcinoma of colon | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Hepatocellular carcinoma | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Invasive ductal breast carcinoma | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Lung neoplasm malignant | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Pancreatic carcinoma metastatic | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Nervous system disorders | ||||
Cerebellar infarction | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Diabetic neuropathy | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Dizziness | 0/544 (0%) | 0 | 2/544 (0.4%) | 2 |
Encephalopathy | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Haemorrhagic stroke | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Headache | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Hypoglycaemic unconsciousness | 3/544 (0.6%) | 3 | 0/544 (0%) | 0 |
Transient ischaemic attack | 2/544 (0.4%) | 2 | 1/544 (0.2%) | 1 |
Vascular parkinsonism | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Product Issues | ||||
Device malfunction | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Psychiatric disorders | ||||
Delusion | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Rapid eye movements sleep abnormal | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Renal and urinary disorders | ||||
Acute kidney injury | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Renal failure | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||
Chronic obstructive pulmonary disease | 0/544 (0%) | 0 | 2/544 (0.4%) | 2 |
Pulmonary oedema | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Respiratory failure | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Surgical and medical procedures | ||||
Aortic valve replacement | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Carpal tunnel decompression | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Rehabilitation therapy | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Vitrectomy | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Vascular disorders | ||||
Aortic aneurysm | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Deep vein thrombosis | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Hypotension | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Peripheral vascular disorder | 1/544 (0.2%) | 1 | 0/544 (0%) | 0 |
Subclavian vein occlusion | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Varicose ulceration | 0/544 (0%) | 0 | 1/544 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
Faster Aspart | NovoRapid | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 32/544 (5.9%) | 33/544 (6.1%) | ||
Infections and infestations | ||||
Nasopharyngitis | 32/544 (5.9%) | 35 | 33/544 (6.1%) | 36 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Name/Title | Clinical Reporting Anchor and Disclosure (1452) |
---|---|
Organization | Novo Nordisk A/S |
Phone | (+1) 866-867-7178 |
clinicaltrials@novonordisk.com |
- NN1218-4113
- U1111-1180-0636
- 2016-000878-38