Diabetes, Diabetes Mellitus, Type 2
Conditions
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).
Interventions
DRUGFaster-acting insulin aspart
Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
DRUGInsulin aspart
Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
DRUGInsulin degludec
Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
DRUGMetformin
Only participants who took metformin before the study should take metformin tablets, same dose as before the study
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | Weeks 0-16 | ADA classification of hypos: 1. Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2. Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3. Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4. Probable symptomatic: No measurement with symptoms. 5. Pseudo: PG \>3.9 mmol/L with symptoms. 6. Unclassifiable. NN classification of hypos: 1. BG confirmed: PG \<3.1 mmol/L with/without symptoms. 2. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \<3.1 mmol/L with symptoms. 3. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \<3.1 mmol/L with/without symptoms. 4. Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia. |
| 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 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 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. |
| 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. |
Countries
Argentina, Bulgaria, Canada, Croatia, Czechia, Germany, Greece, Italy, Poland, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Ukraine, United States
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 details
There was a 12-week run-in period primarily for optimisation of the basal insulin and reinforcement of subject training in trial procedures, diabetes education and dietary training. Out of the 1264 participants enrolled in the study, 173 were run-in failures and 1091 were randomised.
Participants by arm
| Arm | Count |
|---|---|
| Faster Aspart 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. | 546 |
| NovoRapid 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. | 545 |
| Total | 1,091 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 11 | 11 |
Baseline characteristics
| Characteristic | NovoRapid | Total | Faster Aspart |
|---|---|---|---|
| Age, Continuous | 62.1 Years STANDARD_DEVIATION 8.8 | 62.3 Years STANDARD_DEVIATION 8.7 | 62.6 Years STANDARD_DEVIATION 8.6 |
| Race/Ethnicity, Customized Asian | 31 Participants | 74 Participants | 43 Participants |
| Race/Ethnicity, Customized Black or African American | 19 Participants | 33 Participants | 14 Participants |
| Race/Ethnicity, Customized Hispanic Latino | 57 Participants | 118 Participants | 61 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 5 Participants | 7 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 488 Participants | 973 Participants | 485 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 487 Participants | 974 Participants | 487 Participants |
| Sex: Female, Male Female | 256 Participants | 537 Participants | 281 Participants |
| Sex: Female, Male Male | 289 Participants | 554 Participants | 265 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 544 | 1 / 544 |
| other Total, other adverse events | 32 / 544 | 33 / 544 |
| serious Total, serious adverse events | 38 / 544 | 40 / 544 |
Outcome results
Primary
Change in Glycosylated Haemoglobin (HbA1c)
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change in Glycosylated Haemoglobin (HbA1c) | -0.15 Percentage of HbA1c | Standard Deviation 0.62 |
| NovoRapid | Change in Glycosylated Haemoglobin (HbA1c) | -0.09 Percentage of HbA1c | Standard Deviation 0.6 |
Comparison: 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.p-value: 0.3195% CI: [-0.11, 0.03]ANOVA
Secondary
Change From Baseline in 1,5-anhydroglucitol
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in 1,5-anhydroglucitol | 1.38 mmol/L | Standard Deviation 3.1 |
| NovoRapid | Change From Baseline in 1,5-anhydroglucitol | 0.89 mmol/L | Standard Deviation 3.31 |
Secondary
Change From Baseline in 1-hour PPG Increment
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in 1-hour PPG Increment | -0.43 mmol/L | Standard Deviation 2.45 |
| NovoRapid | Change From Baseline in 1-hour PPG Increment | 0.08 mmol/L | Standard Deviation 2.65 |
Secondary
Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT)
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT) | -0.1 U/L | Standard Deviation 9.4 |
| NovoRapid | Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT) | 3.1 U/L | Standard Deviation 65.4 |
Secondary
Change From Baseline in Biochemistry - Albumin
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry - Albumin | 0.02 g/dL | Standard Deviation 0.25 |
| NovoRapid | Change From Baseline in Biochemistry - Albumin | 0.01 g/dL | Standard Deviation 0.26 |
Secondary
Change From Baseline in Biochemistry - Alkaline Phosphatase
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry - Alkaline Phosphatase | 2.9 U/L | Standard Deviation 22.6 |
| NovoRapid | Change From Baseline in Biochemistry - Alkaline Phosphatase | 2.2 U/L | Standard Deviation 18.3 |
Secondary
Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST)
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST) | -0.2 U/L | Standard Deviation 7.9 |
| NovoRapid | Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST) | 2.2 U/L | Standard Deviation 45.7 |
Secondary
Change From Baseline in Biochemistry - Creatinine
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry - Creatinine | 0.1 umol/L | Standard Deviation 11.1 |
| NovoRapid | Change From Baseline in Biochemistry - Creatinine | 1.5 umol/L | Standard Deviation 13.2 |
Secondary
Change From Baseline in Biochemistry - Potassium
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry - Potassium | -0.001 mmol/L | Standard Deviation 0.5 |
| NovoRapid | Change From Baseline in Biochemistry - Potassium | 0.02 mmol/L | Standard Deviation 0.43 |
Secondary
Change From Baseline in Biochemistry - Sodium
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry - Sodium | -0.6 mmol/L | Standard Deviation 2.6 |
| NovoRapid | Change From Baseline in Biochemistry - Sodium | -0.7 mmol/L | Standard Deviation 2.8 |
Secondary
Change From Baseline in Biochemistry - Total Bilirubin
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry - Total Bilirubin | 0.1 umol/L | Standard Deviation 2.7 |
| NovoRapid | Change From Baseline in Biochemistry - Total Bilirubin | 0.1 umol/L | Standard Deviation 3 |
Secondary
Change From Baseline in Biochemistry - Total Protein
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry - Total Protein | -0.01 g/dL | Standard Deviation 0.35 |
| NovoRapid | Change From Baseline in Biochemistry - Total Protein | -0.02 g/dL | Standard Deviation 0.36 |
Secondary
Change From Baseline in Body Mass Index (BMI)
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Body Mass Index (BMI) | 0.43 kg/m^2 | Standard Deviation 1.04 |
| NovoRapid | Change From Baseline in Body Mass Index (BMI) | 0.40 kg/m^2 | Standard Deviation 1.4 |
Secondary
Change From Baseline in Body Weight
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Body Weight | 1.19 kg | Standard Deviation 2.95 |
| NovoRapid | Change From Baseline in Body Weight | 1.12 kg | Standard Deviation 4.01 |
Secondary
Change From Baseline in Electrocardiogram (ECG)
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
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Electrocardiogram (ECG) | Week 0 | Normal | 287 Participants |
| Faster Aspart | Change From Baseline in Electrocardiogram (ECG) | Week 0 | Abnormal NCS | 252 Participants |
| Faster Aspart | Change From Baseline in Electrocardiogram (ECG) | Week 0 | Abnormal CS | 5 Participants |
| Faster Aspart | Change From Baseline in Electrocardiogram (ECG) | Week 16 | Normal | 274 Participants |
| Faster Aspart | Change From Baseline in Electrocardiogram (ECG) | Week 16 | Abnormal NCS | 245 Participants |
| Faster Aspart | Change From Baseline in Electrocardiogram (ECG) | Week 16 | Abnormal CS | 6 Participants |
| NovoRapid | Change From Baseline in Electrocardiogram (ECG) | Week 16 | Abnormal NCS | 253 Participants |
| NovoRapid | Change From Baseline in Electrocardiogram (ECG) | Week 0 | Normal | 270 Participants |
| NovoRapid | Change From Baseline in Electrocardiogram (ECG) | Week 16 | Normal | 272 Participants |
| NovoRapid | Change From Baseline in Electrocardiogram (ECG) | Week 0 | Abnormal NCS | 264 Participants |
| NovoRapid | Change From Baseline in Electrocardiogram (ECG) | Week 16 | Abnormal CS | 8 Participants |
| NovoRapid | Change From Baseline in Electrocardiogram (ECG) | Week 0 | Abnormal CS | 10 Participants |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG)
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Fasting Plasma Glucose (FPG) | 0.56 mmol/L | Standard Deviation 2.38 |
| NovoRapid | Change From Baseline in Fasting Plasma Glucose (FPG) | 0.68 mmol/L | Standard Deviation 2.4 |
Secondary
Change From Baseline in Fundoscopy/Fundus Photography
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
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 0) | Normal | 225 Participants |
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 0) | Abnormal NCS | 287 Participants |
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 0) | Abnormal CS | 32 Participants |
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 16) | Normal | 205 Participants |
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 16) | Abnormal NCS | 278 Participants |
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 16) | Abnormal CS | 31 Participants |
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 0) | Normal | 224 Participants |
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 0) | Abnormal NCS | 288 Participants |
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 0) | Abnormal CS | 32 Participants |
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 16) | Normal | 208 Participants |
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 16) | Abnormal NCS | 276 Participants |
| Faster Aspart | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 16) | Abnormal CS | 30 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 16) | Abnormal NCS | 297 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 0) | Normal | 219 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 0) | Normal | 217 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 0) | Abnormal NCS | 297 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 16) | Normal | 194 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 0) | Abnormal CS | 27 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 0) | Abnormal NCS | 300 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 16) | Normal | 198 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 16) | Abnormal CS | 26 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 16) | Abnormal NCS | 288 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Right eye (week 0) | Abnormal CS | 27 Participants |
| NovoRapid | Change From Baseline in Fundoscopy/Fundus Photography | Left eye (week 16) | Abnormal CS | 30 Participants |
Secondary
Change From Baseline in Haematology - Erythrocytes
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Haematology - Erythrocytes | -0.02 10^12 erythrocytes/L | Standard Deviation 0.28 |
| NovoRapid | Change From Baseline in Haematology - Erythrocytes | -0.04 10^12 erythrocytes/L | Standard Deviation 0.27 |
Secondary
Change From Baseline in Haematology - Haematocrit
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Haematology - Haematocrit | 0.48 Percentage | Standard Deviation 2.47 |
| NovoRapid | Change From Baseline in Haematology - Haematocrit | 0.35 Percentage | Standard Deviation 2.47 |
Secondary
Change From Baseline in Haematology - Haemoglobin
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Haematology - Haemoglobin | -0.02 mmol/L | Standard Deviation 0.47 |
| NovoRapid | Change From Baseline in Haematology - Haemoglobin | -0.04 mmol/L | Standard Deviation 0.43 |
Secondary
Change From Baseline in Haematology - Leukocytes
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Haematology - Leukocytes | 0.01 10^9 leukocytes/L | Standard Deviation 1.6 |
| NovoRapid | Change From Baseline in Haematology - Leukocytes | -0.01 10^9 leukocytes/L | Standard Deviation 1.35 |
Secondary
Change From Baseline in Haematology - Thrombocytes
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Haematology - Thrombocytes | -0.9 10^9 thrombocytes/L | Standard Deviation 37.1 |
| NovoRapid | Change From Baseline in Haematology - Thrombocytes | -1.3 10^9 thrombocytes/L | Standard Deviation 38.7 |
Secondary
Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline
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
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline | Total cholesterol | 1.01 Ratio | Geometric Coefficient of Variation 15.98 |
| Faster Aspart | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline | High density lipoproteins | 0.97 Ratio | Geometric Coefficient of Variation 14.47 |
| Faster Aspart | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline | Low density lipoproteins | 0.99 Ratio | Geometric Coefficient of Variation 25.36 |
| NovoRapid | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline | Total cholesterol | 1.00 Ratio | Geometric Coefficient of Variation 17.09 |
| NovoRapid | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline | High density lipoproteins | 0.98 Ratio | Geometric Coefficient of Variation 17.57 |
| NovoRapid | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline | Low density lipoproteins | 0.99 Ratio | Geometric Coefficient of Variation 40.51 |
Secondary
Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile | -0.56 mmol/L | Standard Deviation 1.66 |
| NovoRapid | Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile | -0.50 mmol/L | Standard Deviation 1.61 |
Secondary
Change From Baseline in Physical Examination
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
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Physical Examination | Cardiovascular system (week 0) | Abnormal CS | 6 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 16) | Abnormal NCS | 40 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (Week 0) | Normal | 491 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 16) | Abnormal CS | 0 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 0) | Abnormal NCS | 133 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Musculoskeletal system (week 0) | Normal | 504 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (Week 0) | Abnormal NCS | 53 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Musculoskeletal system (week 0) | Abnormal NCS | 36 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Cardiovascular system (week 16) | Abnormal NCS | 71 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Musculoskeletal system (week 16) | Normal | 489 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Musculoskeletal system (week 0) | Abnormal CS | 4 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (Week 0) | Abnormal CS | 0 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 0) | Abnormal CS | 13 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Musculoskeletal system (week 16) | Abnormal NCS | 32 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (week 16) | Normal | 480 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Musculoskeletal system (week 16) | Abnormal CS | 4 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Cardiovascular system (week 0) | Abnormal NCS | 79 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Respiratory system (week 0) | Normal | 535 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (week 16) | Abnormal NCS | 45 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Respiratory system (week 0) | Abnormal NCS | 9 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 16) | Normal | 383 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Cardiovascular system (week 16) | Abnormal CS | 6 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Respiratory system (week 0) | Abnormal CS | 0 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (week 16) | Abnormal CS | 0 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Respiratory system (week 16) | Normal | 520 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Cardiovascular system (week 16) | Normal | 448 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Respiratory system (week 16) | Abnormal NCS | 5 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 0) | Normal | 498 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Respiratory system (week 16) | Abnormal CS | 0 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 16) | Abnormal NCS | 128 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Skin (week 0) | Normal | 438 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 0) | Abnormal NCS | 43 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Skin (week 0) | Abnormal NCS | 96 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 0) | Normal | 398 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Skin (week 0) | Abnormal CS | 10 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 0) | Abnormal CS | 3 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Skin (week 16) | Normal | 418 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 16) | Abnormal CS | 14 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Skin (week 16) | Abnormal NCS | 98 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 16) | Normal | 485 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Skin (week 16) | Abnormal CS | 9 Participants |
| Faster Aspart | Change From Baseline in Physical Examination | Cardiovascular system (week 0) | Normal | 459 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Skin (week 16) | Abnormal CS | 5 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Cardiovascular system (week 0) | Normal | 460 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Cardiovascular system (week 0) | Abnormal NCS | 79 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Cardiovascular system (week 0) | Abnormal CS | 5 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Cardiovascular system (week 16) | Normal | 457 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Cardiovascular system (week 16) | Abnormal NCS | 72 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Cardiovascular system (week 16) | Abnormal CS | 4 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 0) | Normal | 404 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 0) | Abnormal NCS | 127 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 0) | Abnormal CS | 13 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 16) | Normal | 400 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 16) | Abnormal NCS | 122 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Central and Peripheral nervous sys. (week 16) | Abnormal CS | 11 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (Week 0) | Normal | 485 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (Week 0) | Abnormal NCS | 59 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (Week 0) | Abnormal CS | 0 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (week 16) | Normal | 476 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (week 16) | Abnormal NCS | 57 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Gastrointestinal sys. including mouth (week 16) | Abnormal CS | 0 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 0) | Normal | 492 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 0) | Abnormal NCS | 48 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 0) | Abnormal CS | 4 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 16) | Normal | 483 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 16) | Abnormal NCS | 49 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Head, ears, eyes, nose, throat, neck (week 16) | Abnormal CS | 1 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Musculoskeletal system (week 0) | Normal | 496 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Musculoskeletal system (week 0) | Abnormal NCS | 42 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Musculoskeletal system (week 0) | Abnormal CS | 6 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Musculoskeletal system (week 16) | Normal | 494 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Musculoskeletal system (week 16) | Abnormal NCS | 33 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Musculoskeletal system (week 16) | Abnormal CS | 6 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Respiratory system (week 0) | Normal | 534 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Respiratory system (week 0) | Abnormal NCS | 9 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Respiratory system (week 0) | Abnormal CS | 1 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Respiratory system (week 16) | Normal | 517 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Respiratory system (week 16) | Abnormal NCS | 14 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Respiratory system (week 16) | Abnormal CS | 2 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Skin (week 0) | Normal | 429 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Skin (week 0) | Abnormal NCS | 108 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Skin (week 0) | Abnormal CS | 7 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Skin (week 16) | Normal | 430 Participants |
| NovoRapid | Change From Baseline in Physical Examination | Skin (week 16) | Abnormal NCS | 98 Participants |
Secondary
Change From Baseline in Vital Signs: Pulse
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Vital Signs: Pulse | 0.5 Beats per min | Standard Deviation 9 |
| NovoRapid | Change From Baseline in Vital Signs: Pulse | 0.03 Beats per min | Standard Deviation 8.9 |
Secondary
Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure | Systolic blood pressure | 0.4 mmHg | Standard Deviation 14 |
| Faster Aspart | Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure | Diastolic blood pressure | -0.4 mmHg | Standard Deviation 8.9 |
| NovoRapid | Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure | Systolic blood pressure | -1.2 mmHg | Standard Deviation 14.8 |
| NovoRapid | Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure | Diastolic blood pressure | -0.7 mmHg | Standard Deviation 8.9 |
Secondary
Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile | 0.82 Ratio | Geometric Coefficient of Variation 48.32 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile | 0.85 Ratio | Geometric Coefficient of Variation 55.06 |
Secondary
Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements
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
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements | Bedtime to 04:00 | 0.70 mmol/L | Standard Deviation 4.09 |
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements | Bedtime to breakfast | 1.30 mmol/L | Standard Deviation 4.25 |
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements | 04:00 to breakfast | 0.66 mmol/L | Standard Deviation 2.76 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements | Bedtime to 04:00 | 0.29 mmol/L | Standard Deviation 4.09 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements | Bedtime to breakfast | 0.90 mmol/L | Standard Deviation 3.99 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements | 04:00 to breakfast | 0.75 mmol/L | Standard Deviation 2.87 |
Secondary
Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)
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
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast | -0.56 mmol/L | Standard Deviation 2.23 |
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch | -0.38 mmol/L | Standard Deviation 2.69 |
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal | -0.44 mmol/L | Standard Deviation 2.61 |
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | All meals | -0.48 mmol/L | Standard Deviation 1.55 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | All meals | -0.23 mmol/L | Standard Deviation 1.42 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast | -0.42 mmol/L | Standard Deviation 2.17 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal | -0.10 mmol/L | Standard Deviation 2.28 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch | -0.23 mmol/L | Standard Deviation 2.46 |
Secondary
Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)
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
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast | -0.38 mmol/L | Standard Deviation 2.53 |
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch | -0.78 mmol/L | Standard Deviation 2.48 |
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal | -1.04 mmol/L | Standard Deviation 2.67 |
| Faster Aspart | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | All meals | -0.75 mmol/L | Standard Deviation 1.89 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | All meals | -0.52 mmol/L | Standard Deviation 1.91 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast | -0.28 mmol/L | Standard Deviation 2.44 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal | -0.71 mmol/L | Standard Deviation 2.5 |
| NovoRapid | Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch | -0.58 mmol/L | Standard Deviation 2.68 |
Secondary
Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])
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
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) | 1-hour | 0.03 mmol/L | Standard Deviation 3.3 |
| Faster Aspart | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) | 3-hour | 0.30 mmol/L | Standard Deviation 3.85 |
| Faster Aspart | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) | 2-hour | 0.08 mmol/L | Standard Deviation 3.96 |
| Faster Aspart | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) | 4-hour | 0.51 mmol/L | Standard Deviation 3.47 |
| Faster Aspart | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) | 30-min | 0.31 mmol/L | Standard Deviation 2.9 |
| NovoRapid | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) | 4-hour | 0.75 mmol/L | Standard Deviation 3.51 |
| NovoRapid | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) | 30-min | 0.55 mmol/L | Standard Deviation 2.8 |
| NovoRapid | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) | 1-hour | 0.68 mmol/L | Standard Deviation 3.23 |
| NovoRapid | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) | 2-hour | 0.61 mmol/L | Standard Deviation 3.48 |
| NovoRapid | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) | 3-hour | 0.89 mmol/L | Standard Deviation 3.72 |
Secondary
Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)
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
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 1-hour | -0.43 mmol/L | Standard Deviation 2.45 |
| Faster Aspart | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 3-hour | -0.15 mmol/L | Standard Deviation 3.23 |
| Faster Aspart | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 2-hour | -0.37 mmol/L | Standard Deviation 3.25 |
| Faster Aspart | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 4-hour | 0.04 mmol/L | Standard Deviation 3 |
| Faster Aspart | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 30-min | -0.13 mmol/L | Standard Deviation 1.85 |
| NovoRapid | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 4-hour | 0.15 mmol/L | Standard Deviation 3.45 |
| NovoRapid | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 30-min | -0.05 mmol/L | Standard Deviation 1.95 |
| NovoRapid | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 1-hour | 0.08 mmol/L | Standard Deviation 2.65 |
| NovoRapid | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 2-hour | 0.001 mmol/L | Standard Deviation 3.13 |
| NovoRapid | Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 3-hour | 0.28 mmol/L | Standard Deviation 3.54 |
Secondary
Individual Meal Insulin Dose: in Units
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
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Individual Meal Insulin Dose: in Units | Breakfast | 16.27 Units | Standard Deviation 12.04 |
| Faster Aspart | Individual Meal Insulin Dose: in Units | Lunch | 18.51 Units | Standard Deviation 12.09 |
| Faster Aspart | Individual Meal Insulin Dose: in Units | Daily main evening meal | 19.88 Units | Standard Deviation 13.46 |
| NovoRapid | Individual Meal Insulin Dose: in Units | Breakfast | 15.52 Units | Standard Deviation 11.38 |
| NovoRapid | Individual Meal Insulin Dose: in Units | Lunch | 17.96 Units | Standard Deviation 11.73 |
| NovoRapid | Individual Meal Insulin Dose: in Units | Daily main evening meal | 19.85 Units | Standard Deviation 14.47 |
Secondary
Individual Meal Insulin Dose: in Units/kg
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
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Individual Meal Insulin Dose: in Units/kg | Breakfast | 0.17 Units/kg | Standard Deviation 0.12 |
| Faster Aspart | Individual Meal Insulin Dose: in Units/kg | Lunch | 0.19 Units/kg | Standard Deviation 0.11 |
| Faster Aspart | Individual Meal Insulin Dose: in Units/kg | Daily main evening meal | 0.21 Units/kg | Standard Deviation 0.13 |
| NovoRapid | Individual Meal Insulin Dose: in Units/kg | Breakfast | 0.16 Units/kg | Standard Deviation 0.11 |
| NovoRapid | Individual Meal Insulin Dose: in Units/kg | Lunch | 0.19 Units/kg | Standard Deviation 0.12 |
| NovoRapid | Individual Meal Insulin Dose: in Units/kg | Daily main evening meal | 0.20 Units/kg | Standard Deviation 0.14 |
Secondary
Number of Treatment Emergent Adverse Events
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart | Number of Treatment Emergent Adverse Events | 667 Events |
| NovoRapid | Number of Treatment Emergent Adverse Events | 643 Events |
Secondary
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
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
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | 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 | ADA: Severe | 4 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Documented symptomatic | 1162 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Asymptomatic | 651 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Probable symptomatic | 21 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Pseudo | 45 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: BG confirmed | 529 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Severe or BG confirmed symptomatic | 376 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Unclassifiable | 1350 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Severe or BG confirmed | 533 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Severe | 8 Number of hypoglycaemic episodes |
| NovoRapid | 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 | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Documented symptomatic | 1436 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: BG confirmed | 719 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Asymptomatic | 585 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Unclassifiable | 1337 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Probable symptomatic | 16 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed symptomatic | 608 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Pseudo | 19 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed | 727 Number of hypoglycaemic episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)
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
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Probable symptomatic | 62 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | NN: BG confirmed | 2016 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Asymptomatic | 3617 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | NN: Severe or BG confirmed symptomatic | 1333 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Pseudo | 141 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | NN: Severe or BG confirmed | 2032 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Documented symptomatic | 4703 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | NN: Unclassifiable | 6510 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Unclassifiable | 3 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Severe | 16 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Severe | 12 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Documented symptomatic | 5700 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Asymptomatic | 3484 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Probable symptomatic | 64 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Pseudo | 66 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | ADA: Unclassifiable | 3 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | NN: BG confirmed | 2442 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | NN: Severe or BG confirmed symptomatic | 1814 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | NN: Severe or BG confirmed | 2454 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) | NN: Unclassifiable | 6875 Number of hypoglycaemic episodes |
Secondary
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
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
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | 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 | ADA: Probable symptomatic | 11 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: BG confirmed | 72 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Asymptomatic | 87 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Severe or BG confirmed symptomatic | 48 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Pseudo | 2 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Severe or BG confirmed | 74 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Documented symptomatic | 149 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Unclassifiable | 177 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Severe | 2 Number of hypoglycaemic episodes |
| NovoRapid | 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 | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Severe | 0 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Documented symptomatic | 148 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Asymptomatic | 80 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Probable symptomatic | 8 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Pseudo | 4 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: BG confirmed | 65 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed symptomatic | 50 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed | 65 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Unclassifiable | 175 Number of hypoglycaemic episodes |
Secondary
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
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
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | 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 | ADA: Probable symptomatic | 16 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: BG confirmed | 233 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Asymptomatic | 201 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Severe or BG confirmed symptomatic | 181 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Pseudo | 10 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Severe or BG confirmed | 235 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Documented symptomatic | 465 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Unclassifiable | 459 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Severe | 2 Number of hypoglycaemic episodes |
| NovoRapid | 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 | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Severe | 1 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Documented symptomatic | 446 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Asymptomatic | 159 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Probable symptomatic | 11 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Pseudo | 7 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: BG confirmed | 246 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed symptomatic | 212 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed | 247 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Unclassifiable | 377 Number of hypoglycaemic episodes |
Secondary
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
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
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | 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 | ADA: Probable symptomatic | 37 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: BG confirmed | 762 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Asymptomatic | 852 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Severe or BG confirmed symptomatic | 557 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Pseudo | 55 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Severe or BG confirmed | 768 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Documented symptomatic | 1627 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | NN: Unclassifiable | 1809 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | 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 | ADA: Severe | 6 Number of hypoglycaemic episodes |
| NovoRapid | 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 | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Severe | 9 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Documented symptomatic | 1882 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Asymptomatic | 744 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Probable symptomatic | 27 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Pseudo | 26 Number of hypoglycaemic episodes |
| NovoRapid | 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 | ADA: Unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: BG confirmed | 965 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed symptomatic | 820 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed | 974 Number of hypoglycaemic episodes |
| NovoRapid | 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 | NN: Unclassifiable | 1714 Number of hypoglycaemic episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)
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
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Probable symptomatic | 6 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | NN: BG confirmed | 193 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Asymptomatic | 144 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | NN: Severe or BG confirmed symptomatic | 157 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Pseudo | 4 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | NN: Severe or BG confirmed | 195 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Documented symptomatic | 335 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | NN: Unclassifiable | 296 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Severe | 2 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Severe | 2 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Documented symptomatic | 465 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Asymptomatic | 197 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Probable symptomatic | 4 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Pseudo | 9 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | ADA: Unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | NN: BG confirmed | 293 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | NN: Severe or BG confirmed symptomatic | 241 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | NN: Severe or BG confirmed | 295 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | NN: Unclassifiable | 382 Number of hypoglycaemic episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall
ADA classification of hypos: 1. Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2. Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3. Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4. Probable symptomatic: No measurement with symptoms. 5. Pseudo: PG \>3.9 mmol/L with symptoms. 6. Unclassifiable. NN classification of hypos: 1. BG confirmed: PG \<3.1 mmol/L with/without symptoms. 2. Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG \<3.1 mmol/L with symptoms. 3. Severe or BG confirmed: Severe as per ADA and BG confirmed by PG \<3.1 mmol/L with/without symptoms. 4. Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia.
Time frame: Weeks 0-16
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Severe | 18 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Documented symptomatic | 5038 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Asymptomatic | 3761 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Probable symptomatic | 68 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Pseudo | 145 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Unclassifiable | 3 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: BG confirmed | 2209 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed symptomatic | 1490 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Unclassifiable | 6806 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed | 2227 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Unclassifiable | 3 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Severe | 14 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | Not able to selftreat - unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Documented symptomatic | 6165 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: BG confirmed | 2735 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Asymptomatic | 3681 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Unclassifiable | 7257 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Probable symptomatic | 68 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed symptomatic | 2055 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Pseudo | 75 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed | 2749 Number of hypoglycaemic episodes |
Secondary
Number of Treatment Emergent Injection Site Reactions
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart | Number of Treatment Emergent Injection Site Reactions | 3 Number of injection site reactions |
| NovoRapid | Number of Treatment Emergent Injection Site Reactions | 1 Number of injection site reactions |
Secondary
Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)
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
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Faster Aspart | Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No) | Yes | 265 Participants |
| Faster Aspart | Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No) | No | 281 Participants |
| NovoRapid | Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No) | No | 267 Participants |
| NovoRapid | Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No) | Yes | 278 Participants |
Secondary
Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No)
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
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Faster Aspart | Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No) | Yes | 271 Participants |
| Faster Aspart | Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No) | No | 275 Participants |
| NovoRapid | Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No) | Yes | 282 Participants |
| NovoRapid | Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No) | No | 263 Participants |
Secondary
Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No)
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
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Faster Aspart | Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No) | Yes | 186 Participants |
| Faster Aspart | Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No) | No | 360 Participants |
| NovoRapid | Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No) | Yes | 192 Participants |
| NovoRapid | Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No) | No | 353 Participants |
Secondary
Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No)
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
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Faster Aspart | Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No) | Yes | 182 Participants |
| Faster Aspart | Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No) | No | 364 Participants |
| NovoRapid | Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No) | Yes | 190 Participants |
| NovoRapid | Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No) | No | 355 Participants |
Secondary
Total Basal Insulin Dose: in Units/Day
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Total Basal Insulin Dose: in Units/Day | 63.76 Units/day | Standard Deviation 35.21 |
| NovoRapid | Total Basal Insulin Dose: in Units/Day | 62.25 Units/day | Standard Deviation 36.03 |
Secondary
Total Basal Insulin Dose: in Units/kg/Day
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Total Basal Insulin Dose: in Units/kg/Day | 0.66 Units/kg/day | Standard Deviation 0.32 |
| NovoRapid | Total Basal Insulin Dose: in Units/kg/Day | 0.64 Units/kg/day | Standard Deviation 0.32 |
Secondary
Total Bolus Insulin Dose: in Units/Day
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Total Bolus Insulin Dose: in Units/Day | 54.72 Units/day | Standard Deviation 35.82 |
| NovoRapid | Total Bolus Insulin Dose: in Units/Day | 53.38 Units/day | Standard Deviation 35.35 |
Secondary
Total Bolus Insulin Dose: in Units/kg/Day
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
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Total Bolus Insulin Dose: in Units/kg/Day | 0.57 Units/kg/day | Standard Deviation 0.33 |
| NovoRapid | Total Bolus Insulin Dose: in Units/kg/Day | 0.55 Units/kg/day | Standard Deviation 0.34 |