Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.
Interventions
DRUGFaster-acting insulin aspart
Injected s.c. /subcutaneously (under the skin)
DRUGinsulin aspart
Injected s.c. /subcutaneously (under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age at least 18 years at the time of signing the informed consent * Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening * Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.) * HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening * Body mass index (BMI) below or equal to 35.0 kg/m\^2 at screening * Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial
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 * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening * Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | Week 0, week 16 | Change from baseline (week 0) in HbA1c 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 period: the observation period from date of randomisation until last trial-related subject-site contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM | Week 0, week 16 | Change from baseline (week 0) in low interstitial glucose (IG) (≤3.9 mmol/L \[70 mg/dL\]) during continuous glucose monitoring (CGM) 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. |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Week 0, week 16 | Change from baseline (week 0) in FPG 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. |
| Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) | Week 16 | Percentage of subjects reaching HbA1c \<7.0% (53 mmol/mol) was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period. |
| Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes | Week 16 | Percentage of subjects reaching HbA1c \<7.0% (53 mmol/mol) without treatment emergent severe hypoglycaemic episodes was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of IMP administration after randomisation (in week 0) and no later than one day after the last day on IMP (i.e., maximum week 16 + 1 day). The results are based on the in-trial period. |
| Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour 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. 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 in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | Week 0, week 16 | Change from baseline (week 0) in 30-min, 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. 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 PPG was evaluated after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal. |
| Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile | Week 0, week 16 | Change from baseline (week 0) in mean of the 7-7-9 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. 7-7-9 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 7-7-9 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 7-7-9 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. |
| Change From Baseline of the 7-7-9 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 7-7-9 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. |
| Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Week 0, week 16 | Change from baseline (week 0) in pre-prandial PG (pre-breakfast, pre-lunch, pre-main evening meal and mean over all meals) of the 7-7-9 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. |
| Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 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 7-7-9 point SMPG profile at baseline (week 0) and after 16 weeks of randomisation (i.e., week 16). The results are based on the last in-trial value, which included the last available measurement in the in-trial period. |
| Change From Baseline of the 7-7-9 Point SMPG Profile: in 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 7-7-9 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. |
| Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] | Week 16 | Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L \[140 mg/dL\] was evaluated after 16 weeks of randomisation. Subjects 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 in-trial period. |
| Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia | Week 16 | Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L \[140 mg/dL\] without treatment emergent severe hypoglycaemia was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. The results are based on the in-trial period. |
| Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | Week 0, week 16 | Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values at baseline (week 0) and 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. |
| Insulin Dose in Units/Day: Total Basal | Week 16 | 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: the observation period from date of first dose of randomised trial products (faster aspart and NovoRapid®) to no later than 7 days after the day of last dose of randomised trial products. |
| Insulin Dose in Units/Day: Total Bolus | Week 16 | 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. |
| Insulin Dose in Units/Day: Total Daily Insulin Dose | Week 16 | Total 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. |
| Insulin Dose in Units/Day: Individual Meal Insulin Dose | Week 16 | No data was collected for individual meal insulin dose. |
| Insulin Dose in Units/kg/Day: Total Basal | Week 16 | 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. |
| Insulin Dose in Units/kg/Day: Total Bolus | Week 16 | 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. |
| Insulin Dose in Units/kg/Day: Total Daily Insulin Dose | Week 16 | Total 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. |
| Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose | Week 16 | No data was collected for individual meal insulin dose. |
| Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio | Week 16 | Insulin carbohydrate ratio 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. |
| Insulin Delivery Pump Parameter: Glucose Sensitivity Factor | Week 16 | Glucose sensitivity factor 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. |
| Insulin Delivery Pump Parameter: Active Insulin Time | Week 16 | Active insulin time 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. |
| Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Week 0, week 16 | Change from baseline (week 0) in mean interstitial glucose (IG) increment (0-30 minutes (min), 0-1 hour (h) and 0-2 h after start of meal) (breakfast, lunch, main evening meal and mean across all meals) 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. |
| Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Week 0, week 16 | Change from baseline (week 0) in mean time to the IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) 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. |
| Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Week 0, week 16 | Change from baseline (week 0) in mean IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) 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. |
| Number of Treatment Emergent Infusion Site Reactions | Weeks 0-16 | Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period. |
| Number of Treatment Emergent Adverse Events (AEs) | Weeks 0-16 | Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 16. A TEAE was defined as an event that has an onset date on or after the first day of exposure to randomised treatment (in week 0), and no later than seven days after the last day of randomised treatment (i.e., maximum week 16 + 7 days). The results are based on the on-treatment period. |
| Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | Week 16 | Percentage of time spent with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L \[45, 54, 63, 70 mg/dL\]) and IG \>10.0, 12.0, 13.9 mmol/L \[180, 216, 250 mg/dL\]) 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. |
| Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | Week 16 | Incidence of episodes with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L \[45, 54, 63, 70 mg/dL\]) and IG \>10.0, 12.0, 13.9 mmol/L \[180, 216, 250 mg/dL\]) 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. |
| Change From Baseline in Mean of the IG Profile | Week 0, week 16 | Change from baseline (week 0) in mean of the IG profile was evaluated after 16 weeks of randomisation. The mean of an IG profile is defined as the time integral of the profile over the profile's length, divided by the profile's length. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. |
| Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) | Week 16 | Percentage of time spent within IG target range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) 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. |
| Variation in the IG Profile | Week 16 | Variation in IG profile was the average absolute difference from the mean of the IG profile. Variation in the IG 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. |
| Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL] | Week 16 | Area under the curve (AUC3.9-IG) for IG ≤3.9 mmol/L \[70 mg/dL\] 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. |
| Change From Baseline in AUCIG,0-15min | Week 0, week 16 | Change from baseline (week 0) in area under the curve for interstitial glucose (AUCIG),0-15 minutes during 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. |
| Change From Baseline in AUCIG,0-30min | Week 0, week 16 | Change from baseline (week 0) in AUCIG,0-30 minutes during 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. |
| Change From Baseline in AUCIG,0-1h | Week 0, week 16 | Change from baseline (week 0) in AUCIG,0-1 hour during 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. |
| Change From Baseline in AUCIG,0-2h | Week 0, week 16 | Change from baseline (week 0) in AUCIG,0-2 hours during 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. |
| Change From Baseline in AUCIG,0-4h | Week 0, week 16 | Change from baseline (week 0) in AUCIG,0-24hours during 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. |
| Change From Baseline in Time to the IG Peak After Start of Meal | Week 0, week 16 | Change from baseline (week 0) in time to the IG peak after start of meal-test meal 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. |
| Change From Baseline in IG Peak After Start of Meal | Week 0, week 16 | Change from baseline (week 0) in IG peak after start of meal-test meal 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. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | Weeks 0-16 | ADA classification of hypo: 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 hypo: 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 hypo. |
| 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. |
| 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. |
| 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. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN 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. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN 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. |
| 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. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 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 between 1 hour to 2 hours after start of the meal. The results are based on the on-treatment period. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 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 3 hours after start of the meal. The results are based on the on-treatment period. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 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 3 to 4 hours after start of the meal. The results are based on the on-treatment period. |
| Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG) | Weeks 0-16 | Unexplained hyperglycaemia was defined as a confirmed PG value ≥16.7 mmol/L (300 mg/dL) and was unexplained (i.e. no apparent medical, dietary, insulin dosage or pump failure reason). The results are based on the on-treatment period. |
| Change From Baseline in Physical Examination: Respiratory System | Week 0, week 16 | Reported results are respiratory system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Baseline in Physical Examination: Cardiovascular System | Week 0, week 16 | Reported results are cardiovascular system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Week 0, week 16 | Reported results are central and peripheral nervous system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Week 0, week 16 | Reported results are gastrointestinal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Baseline in Physical Examination: Musculoskeletal System | Week 0, week 16 | Reported results are musculoskeletal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Baseline in Physical Examination: Skin | Week 0, week 16 | Reported results are skin-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Baseline in Haematology: Thrombocytes | Week 0, week 16 | Change from baseline (week 0) in thrombocytes 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. |
| Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Week 0, week 16 | Reported results are head, ears, eyes, nose, throat and neck-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Baseline in Vital Sign: Blood Pressure | Week 0, week 16 | Change from baseline (week 0) in blood pressure (both systolic and diastolic) 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. |
| Change From Baseline in Vital Sign: Pulse | Week 0, week 16 | Change from baseline (week 0) in pulse 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. |
| Change From Screening in Electrocardiogram (ECG) | Week 0, week 16 | Reported results are ECG findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Screening in Fundus Photography/Fundoscopy | Week 0, week 16 | Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) AAbnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Baseline in Haematology: Haemoglobin | Week 0, week 16 | Change from baseline (week 0) in haemoglobin 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. |
| Change From Baseline in Haematology: Haematocrit | Week 0, week 16 | Change from baseline (week 0) in haematocrit 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. |
| Change From Baseline in Haematology: Erythrocytes | Week 0, week 16 | Change from baseline (week 0) in erythrocytes 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. |
| Change From Baseline in Haematology: Leucocytes | Week 0, week 16 | Change from baseline (week 0) in leucocytes 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. |
| Change From Baseline in Biochemistry: Total Protein | Week 0, week 16 | Change from baseline (week 0) in total protein 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. |
| Change From Baseline in Biochemistry: Creatinine | Week 0, week 16 | Change from baseline (week 0) in creatinine 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. |
| Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT) | Week 0, week 16 | Change from baseline (week 0) in ALT 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. |
| Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST) | Week 0, week 16 | Change from baseline (week 0) in AST 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. |
| Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP) | Week 0, week 16 | Change from baseline (week 0) in ALP 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. |
| Change From Baseline in Biochemistry: Sodium | Week 0, week 16 | Change from baseline (week 0) in sodium 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. |
| Change From Baseline in Biochemistry: Potassium | Week 0, week 16 | Change from baseline (week 0) in potassium 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. |
| Change From Baseline in Biochemistry: Albumin | Week 0, week 16 | Change from baseline (week 0) in albumin 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. |
| Change From Baseline in Biochemistry: Total Bilirubin | Week 0, week 16 | Change from baseline (week 0) in bilirubin 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. |
| Change From Baseline in Urinalysis: Albumin/Creatine Ratio | Week 0, week 16 | Change from baseline (week 0) in albumin/creatine ratio 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. |
| Change From Baseline in Urinalysis: Erythrocytes | Week 0, week 16 | Reported results are urine erythrocytes-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ and e) 3+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Baseline in Urinalysis: Protein | Week 0, week 16 | Reported results are urine protein-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Baseline in Urinalysis: Ketones | Week 0, week 16 | Reported results are urine ketone-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Change From Baseline in Body Weight | Week 0, week 16 | Change from baseline (week 0) in body weight 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. |
| Change From Baseline in Body Mass Index (BMI) | Week 0, week 16 | Change from baseline (week 0) in BMI 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. |
| Number of Change-of-infusion-sets Per Week | Week 0-16 | Number of change-of-infusion-sets per week was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. |
| Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Week 0-16 | Number of subjects with at least one non-routine change-of-infusion-sets categorised by reasons for change-of-infusion-sets was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. Reasons for change-of-infusion-sets are categorised as follows: Category-1: A perceived occlusion by the subject Category-2: Any problems related to the infusion set Category-3: Any technical issues with the pump Category-4: Changes in the insulin solution in the infusion set or reservoir Category-5: High BG with no other explanation which made the subject change the infusion set Category-6: Infusion site reaction Category-7: Missing |
Countries
Belgium, Canada, France, Germany, Netherlands, Russia, Slovenia, United Kingdom, United States
Participant flow
Recruitment details
The trial was conducted at 92 sites in 9 countries.as follows: Belgium (7), Canada (8), France (10), Germany (9), Netherlands (9), Russian Federation (11), Slovenia (2), United Kingdom (6), and United States (30). One (1) site in the Netherlands screened, but didn't randomise any subject.
Pre-assignment details
There was a 4-week run-in period primarily for reinforcement of subject training in trial procedures, diabetes education and collecting baseline assessments. Subjects remained on their pre-trial insulin treatment during the run-in period.
Participants by arm
| Arm | Count |
|---|---|
| Faster Aspart The subjects received faster aspart (basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal. | 236 |
| NovoRapid The subjects received insulin aspart (NovoRapid®/NovoLog®: basal-bolus regimen) by CSII for 16 weeks. Doses of basal and bolus insulin and timing of bolus dose were individually adjusted and thus no maximum dose of insulin was specified. Basal rate insulin adjustment: The purpose of adjusting the basal rates was to ensure that BG was kept between 4.0-6.0 mmol/L \[71-108 mg/dL\] while in a fasting state and during the night. Bolus insulin titration: It was recommended that meal-time bolus insulin was titrated based on carbohydrate-counting using the Bolus Wizard® according to their usual practice and according to instructions from the investigator. Meal-time dosing was defined as bolus infusion initiated 0-2 minutes before a meal. | 236 |
| Total | 472 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Unclassified | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | NovoRapid | Total | Faster Aspart |
|---|---|---|---|
| Age, Continuous | 43.6 Years STANDARD_DEVIATION 14.7 | 43.5 Years STANDARD_DEVIATION 14.7 | 43.3 Years STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 13 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 215 Participants | 425 Participants | 210 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 34 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 38 Participants | 22 Participants |
| Race (NIH/OMB) White | 210 Participants | 419 Participants | 209 Participants |
| Sex: Female, Male Female | 136 Participants | 269 Participants | 133 Participants |
| Sex: Female, Male Male | 100 Participants | 203 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 236 | 0 / 236 |
| other Total, other adverse events | 84 / 236 | 72 / 236 |
| serious Total, serious adverse events | 5 / 236 | 8 / 236 |
Outcome results
Primary
Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline (week 0) in HbA1c 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 period: the observation period from date of randomisation until last trial-related subject-site contact.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change in Glycosylated Haemoglobin (HbA1c) | Baseline | 7.49 Percentage (%) of HbA1c | Standard Deviation 0.55 |
| Faster Aspart | Change in Glycosylated Haemoglobin (HbA1c) | Change from baseline | -0.06 Percentage (%) of HbA1c | Standard Deviation 0.5 |
| NovoRapid | Change in Glycosylated Haemoglobin (HbA1c) | Baseline | 7.49 Percentage (%) of HbA1c | Standard Deviation 0.53 |
| NovoRapid | Change in Glycosylated Haemoglobin (HbA1c) | Change from baseline | -0.14 Percentage (%) of HbA1c | Standard Deviation 0.44 |
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, strata (use of own continuous glucose monitoring), previous insulin use, and region as factors, and baseline HbA1c as a covariate.95% CI: [0.01, 0.17]ANOVA
Secondary
Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]
Area under the curve (AUC3.9-IG) for IG ≤3.9 mmol/L \[70 mg/dL\] 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.
Time frame: Week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL] | 3.19 mmol/L | Standard Deviation 0.22 |
| NovoRapid | Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL] | 3.21 mmol/L | Standard Deviation 0.2 |
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.
Time frame: Week 0, Week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in 1,5-anhydroglucitol | Baseline | 4.20 ug/mL | Standard Deviation 2.34 |
| Faster Aspart | Change From Baseline in 1,5-anhydroglucitol | Change from baseline | 0.14 ug/mL | Standard Deviation 1.48 |
| NovoRapid | Change From Baseline in 1,5-anhydroglucitol | Baseline | 4.13 ug/mL | Standard Deviation 2.14 |
| NovoRapid | Change From Baseline in 1,5-anhydroglucitol | Change from baseline | 0.25 ug/mL | Standard Deviation 1.42 |
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.
Time frame: Week 0, Week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in 1-hour PPG Increment | Baseline | 4.67 mmol/L | Standard Deviation 3.09 |
| Faster Aspart | Change From Baseline in 1-hour PPG Increment | Change from baseline | -0.89 mmol/L | Standard Deviation 3.44 |
| NovoRapid | Change From Baseline in 1-hour PPG Increment | Baseline | 4.62 mmol/L | Standard Deviation 3 |
| NovoRapid | Change From Baseline in 1-hour PPG Increment | Change from baseline | 0.05 mmol/L | Standard Deviation 3.37 |
Secondary
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour 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. 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: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 30-min (Baseline) | 10.54 mmol/L | Standard Deviation 3.33 |
| Faster Aspart | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 1-hour (Baseline) | 12.18 mmol/L | Standard Deviation 3.96 |
| Faster Aspart | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 2-hour (Baseline) | 13.17 mmol/L | Standard Deviation 4.77 |
| Faster Aspart | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 3-hour (Baseline) | 11.38 mmol/L | Standard Deviation 4.65 |
| Faster Aspart | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 4-hour (Baseline) | 9.07 mmol/L | Standard Deviation 4.31 |
| Faster Aspart | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 30-min (Change from baseline) | -0.50 mmol/L | Standard Deviation 4.05 |
| Faster Aspart | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 1-hour (Change from baseline) | -0.85 mmol/L | Standard Deviation 4.65 |
| Faster Aspart | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 2-hour (Change from baseline) | -0.80 mmol/L | Standard Deviation 5.33 |
| Faster Aspart | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 3-hour (Change from baseline) | -0.33 mmol/L | Standard Deviation 5.12 |
| Faster Aspart | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 4-hour (Change from baseline) | 0.00 mmol/L | Standard Deviation 4.76 |
| NovoRapid | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 2-hour (Change from baseline) | 0.42 mmol/L | Standard Deviation 5.01 |
| NovoRapid | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 30-min (Baseline) | 10.30 mmol/L | Standard Deviation 2.96 |
| NovoRapid | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 30-min (Change from baseline) | 0.42 mmol/L | Standard Deviation 3.75 |
| NovoRapid | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 1-hour (Baseline) | 11.96 mmol/L | Standard Deviation 3.81 |
| NovoRapid | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 4-hour (Change from baseline) | 0.21 mmol/L | Standard Deviation 4.1 |
| NovoRapid | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 2-hour (Baseline) | 13.04 mmol/L | Standard Deviation 4.35 |
| NovoRapid | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 1-hour (Change from baseline) | 0.36 mmol/L | Standard Deviation 4.58 |
| NovoRapid | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 3-hour (Baseline) | 11.48 mmol/L | Standard Deviation 4.28 |
| NovoRapid | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 3-hour (Change from baseline) | 0.20 mmol/L | Standard Deviation 4.75 |
| NovoRapid | Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test) | 4-hour (Baseline) | 9.18 mmol/L | Standard Deviation 3.83 |
Secondary
Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)
Change from baseline (week 0) in 30-min, 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. 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 PPG was evaluated after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 30-min (Baseline) | 3.02 mmol/L | Standard Deviation 2.16 |
| Faster Aspart | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 2-hour (Baseline) | 5.65 mmol/L | Standard Deviation 4.12 |
| Faster Aspart | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 3-hour (Baseline) | 3.85 mmol/L | Standard Deviation 4.32 |
| Faster Aspart | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 4-hour (Baseline) | 1.57 mmol/L | Standard Deviation 4.23 |
| Faster Aspart | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 30-min (Change from baseline) | -0.53 mmol/L | Standard Deviation 2.47 |
| Faster Aspart | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 2-hour (Change from baseline) | -0.82 mmol/L | Standard Deviation 4.39 |
| Faster Aspart | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 3-hour (Change from baseline) | -0.35 mmol/L | Standard Deviation 4.53 |
| Faster Aspart | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 4-hour (Change from baseline) | 0.01 mmol/L | Standard Deviation 4.5 |
| NovoRapid | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 4-hour (Change from baseline) | -0.11 mmol/L | Standard Deviation 3.76 |
| NovoRapid | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 30-min (Baseline) | 2.95 mmol/L | Standard Deviation 2.03 |
| NovoRapid | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 30-min (Change from baseline) | 0.11 mmol/L | Standard Deviation 2.25 |
| NovoRapid | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 2-hour (Baseline) | 5.70 mmol/L | Standard Deviation 3.66 |
| NovoRapid | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 3-hour (Change from baseline) | -0.14 mmol/L | Standard Deviation 4.07 |
| NovoRapid | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 3-hour (Baseline) | 4.13 mmol/L | Standard Deviation 3.72 |
| NovoRapid | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 2-hour (Change from baseline) | 0.09 mmol/L | Standard Deviation 4.13 |
| NovoRapid | Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) | 4-hour (Baseline) | 1.83 mmol/L | Standard Deviation 3.52 |
Secondary
Change From Baseline in AUCIG,0-15min
Change from baseline (week 0) in area under the curve for interstitial glucose (AUCIG),0-15 minutes during 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in AUCIG,0-15min | Baseline | 7.55 mmol/L | Standard Deviation 2.63 |
| Faster Aspart | Change From Baseline in AUCIG,0-15min | Change from baseline | 0.16 mmol/L | Standard Deviation 3.06 |
| NovoRapid | Change From Baseline in AUCIG,0-15min | Baseline | 7.37 mmol/L | Standard Deviation 2.2 |
| NovoRapid | Change From Baseline in AUCIG,0-15min | Change from baseline | 0.21 mmol/L | Standard Deviation 2.96 |
Secondary
Change From Baseline in AUCIG,0-1h
Change from baseline (week 0) in AUCIG,0-1 hour during 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in AUCIG,0-1h | Baseline | 9.47 mmol/L | Standard Deviation 2.76 |
| Faster Aspart | Change From Baseline in AUCIG,0-1h | Change from baseline | -0.07 mmol/L | Standard Deviation 3.33 |
| NovoRapid | Change From Baseline in AUCIG,0-1h | Baseline | 9.35 mmol/L | Standard Deviation 2.38 |
| NovoRapid | Change From Baseline in AUCIG,0-1h | Change from baseline | 0.32 mmol/L | Standard Deviation 3.26 |
Secondary
Change From Baseline in AUCIG,0-2h
Change from baseline (week 0) in AUCIG,0-2 hours during 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in AUCIG,0-2h | Change from baseline | -0.38 mmol/L | Standard Deviation 3.76 |
| Faster Aspart | Change From Baseline in AUCIG,0-2h | Baseline | 11.27 mmol/L | Standard Deviation 3.1 |
| NovoRapid | Change From Baseline in AUCIG,0-2h | Baseline | 11.18 mmol/L | Standard Deviation 2.82 |
| NovoRapid | Change From Baseline in AUCIG,0-2h | Change from baseline | 0.37 mmol/L | Standard Deviation 3.9 |
Secondary
Change From Baseline in AUCIG,0-30min
Change from baseline (week 0) in AUCIG,0-30 minutes during 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in AUCIG,0-30min | Baseline | 7.98 mmol/L | Standard Deviation 2.65 |
| Faster Aspart | Change From Baseline in AUCIG,0-30min | Change from baseline | 0.12 mmol/L | Standard Deviation 3.12 |
| NovoRapid | Change From Baseline in AUCIG,0-30min | Baseline | 7.86 mmol/L | Standard Deviation 2.25 |
| NovoRapid | Change From Baseline in AUCIG,0-30min | Change from baseline | 0.22 mmol/L | Standard Deviation 3.02 |
Secondary
Change From Baseline in AUCIG,0-4h
Change from baseline (week 0) in AUCIG,0-24hours during 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in AUCIG,0-4h | Baseline | 11.31 mmol/L | Standard Deviation 3.33 |
| Faster Aspart | Change From Baseline in AUCIG,0-4h | Change from baseline | -0.32 mmol/L | Standard Deviation 4.07 |
| NovoRapid | Change From Baseline in AUCIG,0-4h | Baseline | 11.40 mmol/L | Standard Deviation 3.03 |
| NovoRapid | Change From Baseline in AUCIG,0-4h | Change from baseline | 0.29 mmol/L | Standard Deviation 4.1 |
Secondary
Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT)
Change from baseline (week 0) in ALT 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT) | Baseline | 20.0 U/L | Standard Deviation 11.6 |
| Faster Aspart | Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT) | Change from baseline | 0.1 U/L | Standard Deviation 13.8 |
| NovoRapid | Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT) | Baseline | 19.1 U/L | Standard Deviation 11.5 |
| NovoRapid | Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT) | Change from baseline | 0 U/L | Standard Deviation 9.4 |
Secondary
Change From Baseline in Biochemistry: Albumin
Change from baseline (week 0) in albumin 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry: Albumin | Baseline | 4.32 g/dL | Standard Deviation 0.27 |
| Faster Aspart | Change From Baseline in Biochemistry: Albumin | Change from baseline | -0.01 g/dL | Standard Deviation 0.22 |
| NovoRapid | Change From Baseline in Biochemistry: Albumin | Baseline | 4.31 g/dL | Standard Deviation 0.28 |
| NovoRapid | Change From Baseline in Biochemistry: Albumin | Change from baseline | -0.05 g/dL | Standard Deviation 0.26 |
Secondary
Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP)
Change from baseline (week 0) in ALP 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP) | Baseline | 68.8 U/L | Standard Deviation 20.8 |
| Faster Aspart | Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP) | Change from baseline | 1.2 U/L | Standard Deviation 9.6 |
| NovoRapid | Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP) | Baseline | 69.7 U/L | Standard Deviation 23.9 |
| NovoRapid | Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP) | Change from baseline | 0.8 U/L | Standard Deviation 10 |
Secondary
Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST)
Change from baseline (week 0) in AST 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST) | Baseline | 22.2 U/L | Standard Deviation 9.1 |
| Faster Aspart | Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST) | Change from baseline | -0.1 U/L | Standard Deviation 18.6 |
| NovoRapid | Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST) | Baseline | 20.6 U/L | Standard Deviation 7.8 |
| NovoRapid | Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST) | Change from baseline | -0.4 U/L | Standard Deviation 8.7 |
Secondary
Change From Baseline in Biochemistry: Creatinine
Change from baseline (week 0) in creatinine 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry: Creatinine | Baseline | 73.8 umol/L | Standard Deviation 12.3 |
| Faster Aspart | Change From Baseline in Biochemistry: Creatinine | Change from baseline | 0.9 umol/L | Standard Deviation 7.9 |
| NovoRapid | Change From Baseline in Biochemistry: Creatinine | Baseline | 74.5 umol/L | Standard Deviation 13.3 |
| NovoRapid | Change From Baseline in Biochemistry: Creatinine | Change from baseline | -0.1 umol/L | Standard Deviation 8.2 |
Secondary
Change From Baseline in Biochemistry: Potassium
Change from baseline (week 0) in potassium 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry: Potassium | Baseline | 4.34 mmol/L | Standard Deviation 0.42 |
| Faster Aspart | Change From Baseline in Biochemistry: Potassium | Change from baseline | -0.02 mmol/L | Standard Deviation 0.42 |
| NovoRapid | Change From Baseline in Biochemistry: Potassium | Baseline | 4.30 mmol/L | Standard Deviation 0.39 |
| NovoRapid | Change From Baseline in Biochemistry: Potassium | Change from baseline | -0.01 mmol/L | Standard Deviation 0.41 |
Secondary
Change From Baseline in Biochemistry: Sodium
Change from baseline (week 0) in sodium 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry: Sodium | Baseline | 140.3 mmol/L | Standard Deviation 2.7 |
| Faster Aspart | Change From Baseline in Biochemistry: Sodium | Change from baseline | -0.2 mmol/L | Standard Deviation 2.9 |
| NovoRapid | Change From Baseline in Biochemistry: Sodium | Baseline | 140.3 mmol/L | Standard Deviation 2.7 |
| NovoRapid | Change From Baseline in Biochemistry: Sodium | Change from baseline | -0.2 mmol/L | Standard Deviation 2.5 |
Secondary
Change From Baseline in Biochemistry: Total Bilirubin
Change from baseline (week 0) in bilirubin 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry: Total Bilirubin | Baseline | 8.2 umol/L | Standard Deviation 5.1 |
| Faster Aspart | Change From Baseline in Biochemistry: Total Bilirubin | Change from baseline | -0.3 umol/L | Standard Deviation 3.8 |
| NovoRapid | Change From Baseline in Biochemistry: Total Bilirubin | Change from baseline | -1.0 umol/L | Standard Deviation 3.7 |
| NovoRapid | Change From Baseline in Biochemistry: Total Bilirubin | Baseline | 8.8 umol/L | Standard Deviation 6.4 |
Secondary
Change From Baseline in Biochemistry: Total Protein
Change from baseline (week 0) in total protein 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Biochemistry: Total Protein | Baseline | 6.73 g/dL | Standard Deviation 0.44 |
| Faster Aspart | Change From Baseline in Biochemistry: Total Protein | Change from baseline | 0.03 g/dL | Standard Deviation 0.36 |
| NovoRapid | Change From Baseline in Biochemistry: Total Protein | Baseline | 6.74 g/dL | Standard Deviation 0.47 |
| NovoRapid | Change From Baseline in Biochemistry: Total Protein | Change from baseline | -0.05 g/dL | Standard Deviation 0.4 |
Secondary
Change From Baseline in Body Mass Index (BMI)
Change from baseline (week 0) in BMI 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Body Mass Index (BMI) | Baseline | 26.16 kg/m^2 | Standard Deviation 4.06 |
| Faster Aspart | Change From Baseline in Body Mass Index (BMI) | Change from baseline | 0.12 kg/m^2 | Standard Deviation 0.65 |
| NovoRapid | Change From Baseline in Body Mass Index (BMI) | Baseline | 26.51 kg/m^2 | Standard Deviation 3.89 |
| NovoRapid | Change From Baseline in Body Mass Index (BMI) | Change from baseline | 0.28 kg/m^2 | Standard Deviation 0.74 |
Secondary
Change From Baseline in Body Weight
Change from baseline (week 0) in body weight 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Body Weight | Baseline | 76.86 Kg | Standard Deviation 15.2 |
| Faster Aspart | Change From Baseline in Body Weight | Change from baseline | 0.34 Kg | Standard Deviation 1.9 |
| NovoRapid | Change From Baseline in Body Weight | Baseline | 78.21 Kg | Standard Deviation 14.47 |
| NovoRapid | Change From Baseline in Body Weight | Change from baseline | 0.80 Kg | Standard Deviation 2.14 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline | 7.60 mmol/L | Standard Deviation 2.64 |
| Faster Aspart | Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline | -0.03 mmol/L | Standard Deviation 3.19 |
| NovoRapid | Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline | 7.40 mmol/L | Standard Deviation 2.31 |
| NovoRapid | Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline | 0.25 mmol/L | Standard Deviation 3.05 |
Secondary
Change From Baseline in Haematology: Erythrocytes
Change from baseline (week 0) in erythrocytes 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Haematology: Erythrocytes | Baseline | 4.66 10^12/L | Standard Deviation 0.45 |
| Faster Aspart | Change From Baseline in Haematology: Erythrocytes | Change from baseline | 0.01 10^12/L | Standard Deviation 0.27 |
| NovoRapid | Change From Baseline in Haematology: Erythrocytes | Baseline | 4.72 10^12/L | Standard Deviation 0.42 |
| NovoRapid | Change From Baseline in Haematology: Erythrocytes | Change from baseline | -0.03 10^12/L | Standard Deviation 0.22 |
Secondary
Change From Baseline in Haematology: Haematocrit
Change from baseline (week 0) in haematocrit 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Haematology: Haematocrit | Baseline | 42.23 % of haematocrit | Standard Deviation 3.98 |
| Faster Aspart | Change From Baseline in Haematology: Haematocrit | Change from baseline | 0.09 % of haematocrit | Standard Deviation 2.47 |
| NovoRapid | Change From Baseline in Haematology: Haematocrit | Baseline | 42.37 % of haematocrit | Standard Deviation 3.77 |
| NovoRapid | Change From Baseline in Haematology: Haematocrit | Change from baseline | -0.30 % of haematocrit | Standard Deviation 2.01 |
Secondary
Change From Baseline in Haematology: Haemoglobin
Change from baseline (week 0) in haemoglobin 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Haematology: Haemoglobin | Baseline | 8.62 mmol/L | Standard Deviation 0.82 |
| Faster Aspart | Change From Baseline in Haematology: Haemoglobin | Change from baseline | -0.01 mmol/L | Standard Deviation 0.48 |
| NovoRapid | Change From Baseline in Haematology: Haemoglobin | Baseline | 8.62 mmol/L | Standard Deviation 0.8 |
| NovoRapid | Change From Baseline in Haematology: Haemoglobin | Change from baseline | -0.06 mmol/L | Standard Deviation 0.4 |
Secondary
Change From Baseline in Haematology: Leucocytes
Change from baseline (week 0) in leucocytes 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Haematology: Leucocytes | Baseline | 6.41 10^9/L | Standard Deviation 1.78 |
| Faster Aspart | Change From Baseline in Haematology: Leucocytes | Change from baseline | -0.09 10^9/L | Standard Deviation 1.49 |
| NovoRapid | Change From Baseline in Haematology: Leucocytes | Baseline | 6.32 10^9/L | Standard Deviation 1.7 |
| NovoRapid | Change From Baseline in Haematology: Leucocytes | Change from baseline | -0.03 10^9/L | Standard Deviation 1.22 |
Secondary
Change From Baseline in Haematology: Thrombocytes
Change from baseline (week 0) in thrombocytes 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Haematology: Thrombocytes | Baseline | 246.4 10^9/L | Standard Deviation 58.9 |
| Faster Aspart | Change From Baseline in Haematology: Thrombocytes | Change from baseline | 2.2 10^9/L | Standard Deviation 33.5 |
| NovoRapid | Change From Baseline in Haematology: Thrombocytes | Baseline | 243.6 10^9/L | Standard Deviation 55.3 |
| NovoRapid | Change From Baseline in Haematology: Thrombocytes | Change from baseline | 0.2 10^9/L | Standard Deviation 35.8 |
Secondary
Change From Baseline in IG Peak After Start of Meal
Change from baseline (week 0) in IG peak after start of meal-test meal 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in IG Peak After Start of Meal | Baseline | 14.71 mmol/L | Standard Deviation 3.94 |
| Faster Aspart | Change From Baseline in IG Peak After Start of Meal | Change from baseline | -0.57 mmol/L | Standard Deviation 4.69 |
| NovoRapid | Change From Baseline in IG Peak After Start of Meal | Baseline | 14.69 mmol/L | Standard Deviation 3.65 |
| NovoRapid | Change From Baseline in IG Peak After Start of Meal | Change from baseline | 0.36 mmol/L | Standard Deviation 4.78 |
Secondary
Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)
Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values at baseline (week 0) and 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | Total cholesterol (Baseline) | 4.48 mmol/L |
| Faster Aspart | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | High density lipoproteins (Baseline) | 1.70 mmol/L |
| Faster Aspart | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | Low density lipoproteins (Baseline) | 2.46 mmol/L |
| Faster Aspart | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | Total cholesterol (Last in-trial value) | 4.61 mmol/L |
| Faster Aspart | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | High density lipoproteins (Last in-trial value) | 1.74 mmol/L |
| Faster Aspart | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | Low density lipoproteins (Last in-trial value) | 2.56 mmol/L |
| NovoRapid | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | High density lipoproteins (Last in-trial value) | 1.74 mmol/L |
| NovoRapid | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | Total cholesterol (Baseline) | 4.68 mmol/L |
| NovoRapid | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | Total cholesterol (Last in-trial value) | 4.57 mmol/L |
| NovoRapid | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | High density lipoproteins (Baseline) | 1.71 mmol/L |
| NovoRapid | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | Low density lipoproteins (Last in-trial value) | 2.59 mmol/L |
| NovoRapid | Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) | Low density lipoproteins (Baseline) | 2.63 mmol/L |
Secondary
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)
Change from baseline (week 0) in mean interstitial glucose (IG) increment (0-30 minutes (min), 0-1 hour (h) and 0-2 h after start of meal) (breakfast, lunch, main evening meal and mean across all meals) 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-1 h (Baseline) | 0.39 mmol/L | Standard Deviation 0.75 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-30 min (Baseline) | 0.02 mmol/L | Standard Deviation 0.54 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-30 min (Baseline) | 0.15 mmol/L | Standard Deviation 0.52 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-30 min (Baseline) | 0.13 mmol/L | Standard Deviation 0.37 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-1 h (Baseline) | 0.78 mmol/L | Standard Deviation 0.97 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-1 h (Baseline) | 0.42 mmol/L | Standard Deviation 0.77 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-30 min (Baseline) | 0.23 mmol/L | Standard Deviation 0.61 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-1 h (Baseline) | 0.52 mmol/L | Standard Deviation 0.57 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-2 h (Baseline) | 1.32 mmol/L | Standard Deviation 1.52 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-2 h (Baseline) | 0.99 mmol/L | Standard Deviation 1.19 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-2 h (Baseline) | 0.54 mmol/L | Standard Deviation 1.15 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-2 h (Baseline) | 0.93 mmol/L | Standard Deviation 0.94 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-30 min (Change from baseline) | -0.03 mmol/L | Standard Deviation 0.8 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-30 min (Change from baseline) | 0.05 mmol/L | Standard Deviation 0.61 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-30 min (Change from baseline) | -0.07 mmol/L | Standard Deviation 0.73 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-30min:Change from baseline | -0.01 mmol/L | Standard Deviation 0.46 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-1 h (Change from baseline) | -0.13 mmol/L | Standard Deviation 1.13 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-1 h (Change from baseline) | -0.02 mmol/L | Standard Deviation 0.88 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-1 h (Change from baseline) | -0.16 mmol/L | Standard Deviation 0.95 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-1 h (Change from baseline) | -0.10 mmol/L | Standard Deviation 0.61 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-2 h (Change from baseline) | -0.28 mmol/L | Standard Deviation 1.6 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-2 h (Change from baseline) | -0.24 mmol/L | Standard Deviation 1.32 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-2 h (Change from baseline) | -0.29 mmol/L | Standard Deviation 1.29 |
| Faster Aspart | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-2 h (Change from baseline) | -0.25 mmol/L | Standard Deviation 0.81 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-2 h (Change from baseline) | -0.03 mmol/L | Standard Deviation 1.27 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-30 min (Baseline) | 0.21 mmol/L | Standard Deviation 0.6 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-30 min (Change from baseline) | 0.08 mmol/L | Standard Deviation 0.67 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-30 min (Baseline) | 0.03 mmol/L | Standard Deviation 0.6 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-1 h (Change from baseline) | 0.04 mmol/L | Standard Deviation 0.97 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-30 min (Baseline) | 0.09 mmol/L | Standard Deviation 0.57 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-30 min (Change from baseline) | 0.10 mmol/L | Standard Deviation 0.68 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-30 min (Baseline) | 0.11 mmol/L | Standard Deviation 0.39 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-2 h (Change from baseline) | 0.22 mmol/L | Standard Deviation 1.37 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-1 h (Baseline) | 0.73 mmol/L | Standard Deviation 0.94 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-30 min (Change from baseline) | -0.01 mmol/L | Standard Deviation 0.7 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-1 h (Baseline) | 0.44 mmol/L | Standard Deviation 0.84 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-1 h (Change from baseline) | 0.11 mmol/L | Standard Deviation 0.66 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-1 h (Baseline) | 0.32 mmol/L | Standard Deviation 0.82 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-30min:Change from baseline | 0.06 mmol/L | Standard Deviation 0.46 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-1 h (Baseline) | 0.50 mmol/L | Standard Deviation 0.6 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-2 h (Change from baseline) | 0.12 mmol/L | Standard Deviation 0.86 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-2 h (Baseline) | 1.27 mmol/L | Standard Deviation 1.46 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-1 h (Change from baseline) | 0.14 mmol/L | Standard Deviation 0.99 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-2 h (Baseline) | 0.92 mmol/L | Standard Deviation 1.07 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast 0-2 h (Change from baseline) | 0.16 mmol/L | Standard Deviation 1.45 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal 0-2 h (Baseline) | 0.50 mmol/L | Standard Deviation 1.19 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch 0-1 h (Change from baseline) | 0.15 mmol/L | Standard Deviation 0.99 |
| NovoRapid | Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals 0-2 h (Baseline) | 0.89 mmol/L | Standard Deviation 0.84 |
Secondary
Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)
Change from baseline (week 0) in mean IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Baseline) | 12.43 mmol/L | Standard Deviation 1.97 |
| Faster Aspart | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Baseline) | 12.42 mmol/L | Standard Deviation 2.07 |
| Faster Aspart | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Baseline) | 12.65 mmol/L | Standard Deviation 2.1 |
| Faster Aspart | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals (Baseline) | 12.49 mmol/L | Standard Deviation 1.67 |
| Faster Aspart | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Change from baseline) | 0.10 mmol/L | Standard Deviation 2.24 |
| Faster Aspart | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Change from baseline) | 0.10 mmol/L | Standard Deviation 2.19 |
| Faster Aspart | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Change from baseline) | 0.22 mmol/L | Standard Deviation 2.09 |
| Faster Aspart | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals (Change from baseline) | 0.16 mmol/L | Standard Deviation 1.63 |
| NovoRapid | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals (Change from baseline) | 0.03 mmol/L | Standard Deviation 1.59 |
| NovoRapid | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Baseline) | 12.25 mmol/L | Standard Deviation 2.09 |
| NovoRapid | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Change from baseline) | 0.11 mmol/L | Standard Deviation 2.11 |
| NovoRapid | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Baseline) | 12.56 mmol/L | Standard Deviation 1.84 |
| NovoRapid | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Change from baseline) | -0.13 mmol/L | Standard Deviation 2.14 |
| NovoRapid | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Baseline) | 12.70 mmol/L | Standard Deviation 2.06 |
| NovoRapid | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Change from baseline) | 0.19 mmol/L | Standard Deviation 1.92 |
| NovoRapid | Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals (Baseline) | 12.51 mmol/L | Standard Deviation 1.6 |
Secondary
Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile
Change from baseline (week 0) in mean of the 7-7-9 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. 7-7-9 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: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile | Baseline | 9.24 mmol/L | Standard Deviation 1.71 |
| Faster Aspart | Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile | Change from baseline | 0.19 mmol/L | Standard Deviation 1.91 |
| NovoRapid | Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile | Baseline | 9.10 mmol/L | Standard Deviation 1.4 |
| NovoRapid | Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile | Change from baseline | 0.10 mmol/L | Standard Deviation 1.58 |
Secondary
Change From Baseline in Mean of the IG Profile
Change from baseline (week 0) in mean of the IG profile was evaluated after 16 weeks of randomisation. The mean of an IG profile is defined as the time integral of the profile over the profile's length, divided by the profile's length. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Mean of the IG Profile | Baseline | 9.38 mmol/L | Standard Deviation 1.18 |
| Faster Aspart | Change From Baseline in Mean of the IG Profile | Change from baseline | 0.28 mmol/L | Standard Deviation 1.27 |
| NovoRapid | Change From Baseline in Mean of the IG Profile | Baseline | 9.39 mmol/L | Standard Deviation 1.2 |
| NovoRapid | Change From Baseline in Mean of the IG Profile | Change from baseline | 0.04 mmol/L | Standard Deviation 1.18 |
Secondary
Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)
Change from baseline (week 0) in mean time to the IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Baseline) | 88.95 Minutes | Standard Deviation 25.66 |
| Faster Aspart | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Baseline) | 109.47 Minutes | Standard Deviation 31.78 |
| Faster Aspart | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Baseline) | 110.11 Minutes | Standard Deviation 32.35 |
| Faster Aspart | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals (Baseline) | 103.24 Minutes | Standard Deviation 18.5 |
| Faster Aspart | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Change from baseline) | 0.25 Minutes | Standard Deviation 33.69 |
| Faster Aspart | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Change from baseline) | -2.00 Minutes | Standard Deviation 38.63 |
| Faster Aspart | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Change from baseline) | -2.04 Minutes | Standard Deviation 40.51 |
| Faster Aspart | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals (Change from baseline) | -1.30 Minutes | Standard Deviation 22.01 |
| NovoRapid | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals (Change from baseline) | -1.00 Minutes | Standard Deviation 21.9 |
| NovoRapid | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Baseline) | 97.29 Minutes | Standard Deviation 32.32 |
| NovoRapid | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Change from baseline) | -4.03 Minutes | Standard Deviation 35.49 |
| NovoRapid | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Baseline) | 106.94 Minutes | Standard Deviation 29.67 |
| NovoRapid | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Change from baseline) | -1.43 Minutes | Standard Deviation 38.94 |
| NovoRapid | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Baseline) | 106.91 Minutes | Standard Deviation 29.61 |
| NovoRapid | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Change from baseline) | 1.64 Minutes | Standard Deviation 38.02 |
| NovoRapid | Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal) | Mean across all meals (Baseline) | 103.99 Minutes | Standard Deviation 19.21 |
Secondary
Change From Baseline in Physical Examination: Cardiovascular System
Reported results are cardiovascular system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Physical Examination: Cardiovascular System | Normal, baseline | 233 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Cardiovascular System | Abnormal (NCS), baseline | 1 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Cardiovascular System | Abnormal (CS), baseline | 2 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Cardiovascular System | Normal, last on-treatment value | 231 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Cardiovascular System | Abnormal (NCS), last on-treatment value | 4 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Cardiovascular System | Abnormal (CS), last on-treatment value | 1 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Cardiovascular System | Abnormal (NCS), last on-treatment value | 7 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Cardiovascular System | Normal, baseline | 229 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Cardiovascular System | Normal, last on-treatment value | 228 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Cardiovascular System | Abnormal (NCS), baseline | 7 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Cardiovascular System | Abnormal (CS), last on-treatment value | 1 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Cardiovascular System | Abnormal (CS), baseline | 0 Number of subjects |
Secondary
Change From Baseline in Physical Examination: Central and Peripheral Nervous System
Reported results are central and peripheral nervous system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Normal, baseline | 210 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Abnormal (NCS), baseline | 22 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Abnormal (CS), baseline | 4 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Normal, last on-treatment value | 209 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Abnormal (NCS), last on-treatment value | 23 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Abnormal (CS), last on-treatment value | 4 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Abnormal (NCS), last on-treatment value | 17 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Normal, baseline | 215 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Normal, last on-treatment value | 216 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Abnormal (NCS), baseline | 18 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Abnormal (CS), last on-treatment value | 3 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Central and Peripheral Nervous System | Abnormal (CS), baseline | 3 Number of subjects |
Secondary
Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth
Reported results are gastrointestinal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Normal, baseline | 231 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Abnormal (NCS), baseline | 3 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Abnormal (CS), baseline | 2 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Normal, last on-treatment value | 231 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Abnormal (NCS), last on-treatment value | 4 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Abnormal (CS), last on-treatment value | 1 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Abnormal (NCS), last on-treatment value | 3 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Normal, baseline | 231 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Normal, last on-treatment value | 231 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Abnormal (NCS), baseline | 5 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Abnormal (CS), last on-treatment value | 2 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth | Abnormal (CS), baseline | 0 Number of subjects |
Secondary
Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck
Reported results are head, ears, eyes, nose, throat and neck-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Normal, baseline | 219 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Abnormal (NCS), baseline | 15 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Abnormal (CS), baseline | 2 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Normal, last on-treatment value | 217 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Abnormal (NCS), last on-treatment value | 15 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Abnormal (CS), last on-treatment value | 4 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Abnormal (NCS), last on-treatment value | 16 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Normal, baseline | 221 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Normal, last on-treatment value | 218 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Abnormal (NCS), baseline | 14 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Abnormal (CS), last on-treatment value | 2 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck | Abnormal (CS), baseline | 1 Number of subjects |
Secondary
Change From Baseline in Physical Examination: Musculoskeletal System
Reported results are musculoskeletal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Physical Examination: Musculoskeletal System | Normal, baseline | 222 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Musculoskeletal System | Abnormal (NCS), baseline | 13 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Musculoskeletal System | Abnormal (CS), baseline | 1 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Musculoskeletal System | Normal, last on-treatment value | 223 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Musculoskeletal System | Abnormal (NCS), last on-treatment value | 12 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Musculoskeletal System | Abnormal (CS), last on-treatment value | 1 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Musculoskeletal System | Abnormal (NCS), last on-treatment value | 8 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Musculoskeletal System | Normal, baseline | 227 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Musculoskeletal System | Normal, last on-treatment value | 228 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Musculoskeletal System | Abnormal (NCS), baseline | 9 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Musculoskeletal System | Abnormal (CS), last on-treatment value | 0 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Musculoskeletal System | Abnormal (CS), baseline | 0 Number of subjects |
Secondary
Change From Baseline in Physical Examination: Respiratory System
Reported results are respiratory system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Physical Examination: Respiratory System | Normal, last on-treatment value | 235 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Respiratory System | Abnormal (CS), baseline | 1 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Respiratory System | Abnormal (NCS), last on-treatment value | 0 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Respiratory System | Normal, baseline | 234 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Respiratory System | Abnormal (CS), last on-treatment value | 1 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Respiratory System | Abnormal (NCS), baseline | 1 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Respiratory System | Abnormal (CS), last on-treatment value | 0 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Respiratory System | Abnormal (NCS), baseline | 1 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Respiratory System | Abnormal (CS), baseline | 0 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Respiratory System | Normal, last on-treatment value | 234 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Respiratory System | Abnormal (NCS), last on-treatment value | 2 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Respiratory System | Normal, baseline | 235 Number of subjects |
Secondary
Change From Baseline in Physical Examination: Skin
Reported results are skin-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Physical Examination: Skin | Normal, baseline | 212 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Skin | Abnormal (NCS), baseline | 18 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Skin | Abnormal (CS), baseline | 6 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Skin | Normal, last on-treatment value | 204 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Skin | Abnormal (NCS), last on-treatment value | 21 Number of subjects |
| Faster Aspart | Change From Baseline in Physical Examination: Skin | Abnormal (CS), last on-treatment value | 11 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Skin | Abnormal (NCS), last on-treatment value | 29 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Skin | Normal, baseline | 211 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Skin | Normal, last on-treatment value | 203 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Skin | Abnormal (NCS), baseline | 22 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Skin | Abnormal (CS), last on-treatment value | 4 Number of subjects |
| NovoRapid | Change From Baseline in Physical Examination: Skin | Abnormal (CS), baseline | 3 Number of subjects |
Secondary
Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM
Change from baseline (week 0) in low interstitial glucose (IG) (≤3.9 mmol/L \[70 mg/dL\]) during continuous glucose monitoring (CGM) 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM | Baseline | 85.42 min/day | Standard Deviation 65.2 |
| Faster Aspart | Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM | Change from baseline | -6.96 min/day | Standard Deviation 55.29 |
| NovoRapid | Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM | Baseline | 79.88 min/day | Standard Deviation 60.46 |
| NovoRapid | Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM | Change from baseline | 2.85 min/day | Standard Deviation 58.56 |
Secondary
Change From Baseline in Time to the IG Peak After Start of Meal
Change from baseline (week 0) in time to the IG peak after start of meal-test meal 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Time to the IG Peak After Start of Meal | Baseline | 111.2 Minute | Standard Deviation 45.3 |
| Faster Aspart | Change From Baseline in Time to the IG Peak After Start of Meal | Change from baseline | 1.2 Minute | Standard Deviation 50.5 |
| NovoRapid | Change From Baseline in Time to the IG Peak After Start of Meal | Baseline | 117.0 Minute | Standard Deviation 43 |
| NovoRapid | Change From Baseline in Time to the IG Peak After Start of Meal | Change from baseline | -1.4 Minute | Standard Deviation 51.6 |
Secondary
Change From Baseline in Urinalysis: Albumin/Creatine Ratio
Change from baseline (week 0) in albumin/creatine ratio 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Urinalysis: Albumin/Creatine Ratio | Baseline | 2.67 mg/mmol | Standard Deviation 13.88 |
| Faster Aspart | Change From Baseline in Urinalysis: Albumin/Creatine Ratio | Change from baseline | 0.01 mg/mmol | Standard Deviation 4.76 |
| NovoRapid | Change From Baseline in Urinalysis: Albumin/Creatine Ratio | Baseline | 2.00 mg/mmol | Standard Deviation 7.6 |
| NovoRapid | Change From Baseline in Urinalysis: Albumin/Creatine Ratio | Change from baseline | -0.04 mg/mmol | Standard Deviation 3.11 |
Secondary
Change From Baseline in Urinalysis: Erythrocytes
Reported results are urine erythrocytes-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ and e) 3+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Urinalysis: Erythrocytes | Negative (baseline) | 217 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Erythrocytes | Trace (baseline) | 8 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Erythrocytes | 1+ (baseline) | 5 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Erythrocytes | 2+ (baseline) | 5 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Erythrocytes | 3+ (baseline) | 1 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Erythrocytes | Negative (last on-treatment value) | 217 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Erythrocytes | Trace (last on-treatment value) | 6 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Erythrocytes | 1+ (last on-treatment value) | 3 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Erythrocytes | 2+ (last on-treatment value) | 2 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Erythrocytes | 3+ (last on-treatment value) | 8 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Erythrocytes | 1+ (last on-treatment value) | 3 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Erythrocytes | Negative (baseline) | 215 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Erythrocytes | Negative (last on-treatment value) | 215 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Erythrocytes | Trace (baseline) | 10 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Erythrocytes | 3+ (last on-treatment value) | 4 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Erythrocytes | 1+ (baseline) | 5 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Erythrocytes | Trace (last on-treatment value) | 10 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Erythrocytes | 2+ (baseline) | 1 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Erythrocytes | 2+ (last on-treatment value) | 4 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Erythrocytes | 3+ (baseline) | 5 Number of subjects |
Secondary
Change From Baseline in Urinalysis: Ketones
Reported results are urine ketone-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | Negative (baseline) | 192 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | Trace (baseline) | 31 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | 1+ (baseline) | 11 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | 2+ (baseline) | 2 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | 3+ (baseline) | 0 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | 4+ (baseline) | 0 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | Negative (last on-treatment value) | 194 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | Trace (last on-treatment value) | 25 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | 1+ (last on-treatment value) | 15 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | 2+ (last on-treatment value) | 2 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | 3+ (last on-treatment value) | 0 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Ketones | 4+ (last on-treatment value) | 0 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | 3+ (last on-treatment value) | 0 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | Negative (baseline) | 205 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | Negative (last on-treatment value) | 203 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | Trace (baseline) | 23 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | 2+ (last on-treatment value) | 1 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | 1+ (baseline) | 8 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | Trace (last on-treatment value) | 27 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | 2+ (baseline) | 0 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | 4+ (last on-treatment value) | 0 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | 3+ (baseline) | 0 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | 1+ (last on-treatment value) | 5 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Ketones | 4+ (baseline) | 0 Number of subjects |
Secondary
Change From Baseline in Urinalysis: Protein
Reported results are urine protein-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Baseline in Urinalysis: Protein | Negative (baseline) | 193 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Protein | Trace (baseline) | 31 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Protein | 1+ (baseline) | 8 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Protein | 2+ (baseline) | 4 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Protein | 3+ (baseline) | 0 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Protein | 4+ (baseline) | 0 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Protein | Negative (last on-treatment value) | 196 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Protein | Trace (last on-treatment value) | 27 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Protein | 1+ (last on-treatment value) | 10 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Protein | 2+ (last on-treatment value) | 2 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Protein | 3+ (last on-treatment value) | 1 Number of subjects |
| Faster Aspart | Change From Baseline in Urinalysis: Protein | 4+ (last on-treatment value) | 0 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | 3+ (last on-treatment value) | 0 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | Negative (baseline) | 195 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | Negative (last on-treatment value) | 196 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | Trace (baseline) | 27 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | 2+ (last on-treatment value) | 4 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | 1+ (baseline) | 10 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | Trace (last on-treatment value) | 27 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | 2+ (baseline) | 4 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | 4+ (last on-treatment value) | 0 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | 3+ (baseline) | 0 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | 1+ (last on-treatment value) | 9 Number of subjects |
| NovoRapid | Change From Baseline in Urinalysis: Protein | 4+ (baseline) | 0 Number of subjects |
Secondary
Change From Baseline in Vital Sign: Blood Pressure
Change from baseline (week 0) in blood pressure (both systolic and diastolic) 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Vital Sign: Blood Pressure | Systolic blood pressure (baseline) | 123.6 mmHg | Standard Deviation 14.7 |
| Faster Aspart | Change From Baseline in Vital Sign: Blood Pressure | Diastolic blood pressure (baseline) | 74.8 mmHg | Standard Deviation 9.4 |
| Faster Aspart | Change From Baseline in Vital Sign: Blood Pressure | Systolic blood pressure (change from baseline) | -0.8 mmHg | Standard Deviation 12.3 |
| Faster Aspart | Change From Baseline in Vital Sign: Blood Pressure | Diastolic blood pressure (change from baseline) | -0.7 mmHg | Standard Deviation 8.4 |
| NovoRapid | Change From Baseline in Vital Sign: Blood Pressure | Diastolic blood pressure (change from baseline) | -0.4 mmHg | Standard Deviation 7.7 |
| NovoRapid | Change From Baseline in Vital Sign: Blood Pressure | Systolic blood pressure (baseline) | 122.0 mmHg | Standard Deviation 14.3 |
| NovoRapid | Change From Baseline in Vital Sign: Blood Pressure | Systolic blood pressure (change from baseline) | -0.7 mmHg | Standard Deviation 11.5 |
| NovoRapid | Change From Baseline in Vital Sign: Blood Pressure | Diastolic blood pressure (baseline) | 74.6 mmHg | Standard Deviation 8.7 |
Secondary
Change From Baseline in Vital Sign: Pulse
Change from baseline (week 0) in pulse 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.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline in Vital Sign: Pulse | Baseline | 73.7 Beats/minute | Standard Deviation 11 |
| Faster Aspart | Change From Baseline in Vital Sign: Pulse | Change from baseline | -0.5 Beats/minute | Standard Deviation 9 |
| NovoRapid | Change From Baseline in Vital Sign: Pulse | Baseline | 74.5 Beats/minute | Standard Deviation 11.1 |
| NovoRapid | Change From Baseline in Vital Sign: Pulse | Change from baseline | -0.8 Beats/minute | Standard Deviation 9.6 |
Secondary
Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 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 7-7-9 point SMPG profile at baseline (week 0) and after 16 weeks of randomisation (i.e., week 16). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile | Baseline | 2.14 mmol/L |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile | Last in-trial value | 2.06 mmol/L |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile | Baseline | 2.05 mmol/L |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile | Last in-trial value | 2.06 mmol/L |
Secondary
Change From Baseline of the 7-7-9 Point SMPG Profile: in 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 7-7-9 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | 04:00 to breakfast (Baseline) | -1.29 mmol/L | Standard Deviation 3.61 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | Bedtime to 04:00 (Baseline) | -0.97 mmol/L | Standard Deviation 5.16 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | Bedtime to breakfast (Baseline) | -1.73 mmol/L | Standard Deviation 4.81 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | 04:00 to breakfast (Change from baseline) | -0.50 mmol/L | Standard Deviation 4.83 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | Bedtime to 04:00 (Change from baseline) | 0.81 mmol/L | Standard Deviation 6.59 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | Bedtime to breakfast (Change from baseline) | 0.13 mmol/L | Standard Deviation 6.67 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | Bedtime to 04:00 (Change from baseline) | 0.18 mmol/L | Standard Deviation 5.14 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | 04:00 to breakfast (Baseline) | -1.06 mmol/L | Standard Deviation 3.35 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | 04:00 to breakfast (Change from baseline) | -0.08 mmol/L | Standard Deviation 4.45 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | Bedtime to 04:00 (Baseline) | -0.56 mmol/L | Standard Deviation 3.84 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | Bedtime to breakfast (Change from baseline) | -0.20 mmol/L | Standard Deviation 5.84 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements | Bedtime to breakfast (Baseline) | -1.56 mmol/L | Standard Deviation 3.83 |
Secondary
Change From Baseline of the 7-7-9 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 7-7-9 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (baseline) | 2.62 mmol/L | Standard Deviation 3.16 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (baseline) | 1.80 mmol/L | Standard Deviation 2.77 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (baseline) | 1.04 mmol/L | Standard Deviation 3.07 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Mean over all meals (baseline) | 1.93 mmol/L | Standard Deviation 1.94 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Change from baseline) | -0.75 mmol/L | Standard Deviation 3.9 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Change from baseline) | -0.43 mmol/L | Standard Deviation 3.25 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Change from baseline) | -0.47 mmol/L | Standard Deviation 3.51 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Mean over all meals (Change from baseline) | -0.53 mmol/L | Standard Deviation 1.99 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Mean over all meals (Change from baseline) | 0.12 mmol/L | Standard Deviation 1.92 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (baseline) | 1.93 mmol/L | Standard Deviation 3.28 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Change from baseline) | 0.03 mmol/L | Standard Deviation 3.67 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (baseline) | 1.77 mmol/L | Standard Deviation 2.47 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Change from baseline) | 0.35 mmol/L | Standard Deviation 3.79 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (baseline) | 0.52 mmol/L | Standard Deviation 2.69 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Change from baseline) | -0.27 mmol/L | Standard Deviation 3.13 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) | Mean over all meals (baseline) | 1.48 mmol/L | Standard Deviation 1.86 |
Secondary
Change From Baseline of the 7-7-9 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 7-7-9 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (baseline) | 10.82 mmol/L | Standard Deviation 2.99 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (baseline) | 9.65 mmol/L | Standard Deviation 3.05 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (baseline) | 9.79 mmol/L | Standard Deviation 3.01 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Mean over all meals (baseline) | 10.07 mmol/L | Standard Deviation 2.09 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Change from baseline) | -0.33 mmol/L | Standard Deviation 3.61 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Change from baseline) | 0.27 mmol/L | Standard Deviation 3.75 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Change from baseline) | -0.35 mmol/L | Standard Deviation 3.81 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Mean over all meals (Change from baseline) | 0.06 mmol/L | Standard Deviation 2.33 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Mean over all meals (Change from baseline) | 0.13 mmol/L | Standard Deviation 2.21 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (baseline) | 10.28 mmol/L | Standard Deviation 3.07 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Breakfast (Change from baseline) | 0.23 mmol/L | Standard Deviation 3.79 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (baseline) | 9.62 mmol/L | Standard Deviation 2.68 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (Change from baseline) | 0.58 mmol/L | Standard Deviation 3.61 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Main evening meal (baseline) | 9.34 mmol/L | Standard Deviation 3.06 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Lunch (Change from baseline) | 0.05 mmol/L | Standard Deviation 3.57 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) | Mean over all meals (baseline) | 9.74 mmol/L | Standard Deviation 1.99 |
Secondary
Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)
Change from baseline (week 0) in pre-prandial PG (pre-breakfast, pre-lunch, pre-main evening meal and mean over all meals) of the 7-7-9 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.
Time frame: Week 0, week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-breakfast (baseline) | 8.40 mmol/L | Standard Deviation 2.5 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-lunch (baseline) | 8.28 mmol/L | Standard Deviation 2.85 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-main evening meal (baseline) | 8.68 mmol/L | Standard Deviation 2.76 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-mean over all meals (baseline) | 8.39 mmol/L | Standard Deviation 1.73 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-breakfast (Change from baseline) | 0.36 mmol/L | Standard Deviation 3.33 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-lunch (Change from baseline) | 0.39 mmol/L | Standard Deviation 3.54 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-main evening meal (Change from baseline) | 0.15 mmol/L | Standard Deviation 3.72 |
| Faster Aspart | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-mean over all meals (Change from baseline) | 0.39 mmol/L | Standard Deviation 2 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-mean over all meals (Change from baseline) | 0.21 mmol/L | Standard Deviation 1.84 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-breakfast (baseline) | 8.31 mmol/L | Standard Deviation 2.32 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-breakfast (Change from baseline) | 0.26 mmol/L | Standard Deviation 3.05 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-lunch (baseline) | 8.21 mmol/L | Standard Deviation 2.32 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-main evening meal (Change from baseline) | 0.13 mmol/L | Standard Deviation 3.18 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-main evening meal (baseline) | 8.87 mmol/L | Standard Deviation 2.62 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-lunch (Change from baseline) | 0.21 mmol/L | Standard Deviation 3.12 |
| NovoRapid | Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal) | Pre-mean over all meals (baseline) | 8.45 mmol/L | Standard Deviation 1.54 |
Secondary
Change From Screening in Electrocardiogram (ECG)
Reported results are ECG findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Screening in Electrocardiogram (ECG) | Normal, screening | 178 Number of subjects |
| Faster Aspart | Change From Screening in Electrocardiogram (ECG) | Abnormal (NCS), screening | 58 Number of subjects |
| Faster Aspart | Change From Screening in Electrocardiogram (ECG) | Abnormal (CS), screening | 0 Number of subjects |
| Faster Aspart | Change From Screening in Electrocardiogram (ECG) | Normal, last on-treatment value | 188 Number of subjects |
| Faster Aspart | Change From Screening in Electrocardiogram (ECG) | Abnormal (NCS), last on-treatment value | 44 Number of subjects |
| Faster Aspart | Change From Screening in Electrocardiogram (ECG) | Abnormal (CS), last on-treatment value | 0 Number of subjects |
| NovoRapid | Change From Screening in Electrocardiogram (ECG) | Abnormal (NCS), last on-treatment value | 48 Number of subjects |
| NovoRapid | Change From Screening in Electrocardiogram (ECG) | Normal, screening | 181 Number of subjects |
| NovoRapid | Change From Screening in Electrocardiogram (ECG) | Normal, last on-treatment value | 180 Number of subjects |
| NovoRapid | Change From Screening in Electrocardiogram (ECG) | Abnormal (NCS), screening | 54 Number of subjects |
| NovoRapid | Change From Screening in Electrocardiogram (ECG) | Abnormal (CS), last on-treatment value | 2 Number of subjects |
| NovoRapid | Change From Screening in Electrocardiogram (ECG) | Abnormal (CS), screening | 1 Number of subjects |
Secondary
Change From Screening in Fundus Photography/Fundoscopy
Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) AAbnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Normal), screening | 135 Number of subjects |
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Abnormal [NCS]), screening | 94 Number of subjects |
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Abnormal [CS]), screening | 7 Number of subjects |
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Normal), screening | 132 Number of subjects |
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Abnormal [NCS]), screening | 98 Number of subjects |
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Abnormal [CS]), screening | 6 Number of subjects |
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Normal), last on-treatment value | 130 Number of subjects |
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Abnormal [NCS]), last on-treatment value | 77 Number of subjects |
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Abnormal [CS] last on-treatment value | 10 Number of subjects |
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Normal), last on-treatment value | 127 Number of subjects |
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Abnormal-NCS), last on-treatment value | 80 Number of subjects |
| Faster Aspart | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Abnormal [CS]), last on-treatment value | 10 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Abnormal-NCS), last on-treatment value | 87 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Normal), screening | 136 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Normal), last on-treatment value | 119 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Abnormal [NCS]), screening | 94 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Normal), last on-treatment value | 114 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Abnormal [CS]), screening | 6 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Abnormal [NCS]), last on-treatment value | 82 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Normal), screening | 132 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Abnormal [CS]), last on-treatment value | 7 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Abnormal [NCS]), screening | 98 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Left eye (Abnormal [CS] last on-treatment value | 7 Number of subjects |
| NovoRapid | Change From Screening in Fundus Photography/Fundoscopy | Right eye (Abnormal [CS]), screening | 6 Number of subjects |
Secondary
Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])
Incidence of episodes with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L \[45, 54, 63, 70 mg/dL\]) and IG \>10.0, 12.0, 13.9 mmol/L \[180, 216, 250 mg/dL\]) 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.
Time frame: Week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.5 mmol/L (63 mg/dL) | 4584 Number of Events |
| Faster Aspart | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >10.0 mmol/L (180 mg/dL) | 35194 Number of Events |
| Faster Aspart | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.0 mmol/L (54 mg/dL) | 2848 Number of Events |
| Faster Aspart | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >12.0 mmol/L (216 mg/dL) | 23070 Number of Events |
| Faster Aspart | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.9 mmol/L (70 mg/dL) | 6371 Number of Events |
| Faster Aspart | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >13.9 mmol/L (250 mg/dL) | 14352 Number of Events |
| Faster Aspart | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤2.5 mmol/L (45 mg/dL) | 1570 Number of Events |
| NovoRapid | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >13.9 mmol/L (250 mg/dL) | 12866 Number of Events |
| NovoRapid | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤2.5 mmol/L (45 mg/dL) | 1532 Number of Events |
| NovoRapid | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.0 mmol/L (54 mg/dL) | 2920 Number of Events |
| NovoRapid | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.5 mmol/L (63 mg/dL) | 4742 Number of Events |
| NovoRapid | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.9 mmol/L (70 mg/dL) | 6576 Number of Events |
| NovoRapid | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >10.0 mmol/L (180 mg/dL) | 33176 Number of Events |
| NovoRapid | Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >12.0 mmol/L (216 mg/dL) | 21276 Number of Events |
Secondary
Insulin Delivery Pump Parameter: Active Insulin Time
Active insulin time 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.
Time frame: Week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Insulin Delivery Pump Parameter: Active Insulin Time | 3.6 Hour (h) | Standard Deviation 0.7 |
| NovoRapid | Insulin Delivery Pump Parameter: Active Insulin Time | 3.6 Hour (h) | Standard Deviation 0.7 |
Secondary
Insulin Delivery Pump Parameter: Glucose Sensitivity Factor
Glucose sensitivity factor 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.
Time frame: Week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Insulin Delivery Pump Parameter: Glucose Sensitivity Factor | 2.65 mmol/L/U | Standard Deviation 1.14 |
| NovoRapid | Insulin Delivery Pump Parameter: Glucose Sensitivity Factor | 2.60 mmol/L/U | Standard Deviation 0.98 |
Secondary
Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio
Insulin carbohydrate ratio 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.
Time frame: Week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio | 9.13 Gram (g)/U | Standard Deviation 3.2 |
| NovoRapid | Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio | 9.74 Gram (g)/U | Standard Deviation 6.77 |
Secondary
Insulin Dose in Units/Day: Individual Meal Insulin Dose
No data was collected for individual meal insulin dose.
Time frame: Week 16
Population: No subjects were analysed, as no data was collected for individual meal insulin dose.
Secondary
Insulin Dose in Units/Day: Total Basal
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: the observation period from date of first dose of randomised trial products (faster aspart and NovoRapid®) to no later than 7 days after the day of last dose of randomised trial products.
Time frame: Week 16
Population: The safety analysis set included all subjects receiving at least one dose of the investigational medicinal product (IMP, faster aspart) or its comparator (NovoRapid®/NovoLog®). Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Insulin Dose in Units/Day: Total Basal | 23.82 Unit (U) | Standard Deviation 12.82 |
| NovoRapid | Insulin Dose in Units/Day: Total Basal | 23.87 Unit (U) | Standard Deviation 11.38 |
Secondary
Insulin Dose in Units/Day: Total Bolus
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.
Time frame: Week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Insulin Dose in Units/Day: Total Bolus | 25.91 U | Standard Deviation 17.46 |
| NovoRapid | Insulin Dose in Units/Day: Total Bolus | 25.27 U | Standard Deviation 15.33 |
Secondary
Insulin Dose in Units/Day: Total Daily Insulin Dose
Total 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.
Time frame: Week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Insulin Dose in Units/Day: Total Daily Insulin Dose | 49.72 U | Standard Deviation 27.08 |
| NovoRapid | Insulin Dose in Units/Day: Total Daily Insulin Dose | 49.12 U | Standard Deviation 23.75 |
Secondary
Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose
No data was collected for individual meal insulin dose.
Time frame: Week 16
Population: No subjects were analysed, as no data was collected for individual meal insulin dose.
Secondary
Insulin Dose in Units/kg/Day: Total Basal
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.
Time frame: Week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Insulin Dose in Units/kg/Day: Total Basal | 0.30 U/Kg | Standard Deviation 0.12 |
| NovoRapid | Insulin Dose in Units/kg/Day: Total Basal | 0.30 U/Kg | Standard Deviation 0.11 |
Secondary
Insulin Dose in Units/kg/Day: Total Bolus
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.
Time frame: Week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Insulin Dose in Units/kg/Day: Total Bolus | 0.33 U/Kg | Standard Deviation 0.17 |
| NovoRapid | Insulin Dose in Units/kg/Day: Total Bolus | 0.31 U/Kg | Standard Deviation 0.16 |
Secondary
Insulin Dose in Units/kg/Day: Total Daily Insulin Dose
Total 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.
Time frame: Week 16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Insulin Dose in Units/kg/Day: Total Daily Insulin Dose | 0.63 U/Kg | Standard Deviation 0.24 |
| NovoRapid | Insulin Dose in Units/kg/Day: Total Daily Insulin Dose | 0.61 U/Kg | Standard Deviation 0.23 |
Secondary
Number of Change-of-infusion-sets Per Week
Number of change-of-infusion-sets per week was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart | Number of Change-of-infusion-sets Per Week | 2.55 Number of infusion-sets | Standard Deviation 0.43 |
| NovoRapid | Number of Change-of-infusion-sets Per Week | 2.49 Number of infusion-sets | Standard Deviation 0.47 |
Secondary
Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets
Number of subjects with at least one non-routine change-of-infusion-sets categorised by reasons for change-of-infusion-sets was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. Reasons for change-of-infusion-sets are categorised as follows: Category-1: A perceived occlusion by the subject Category-2: Any problems related to the infusion set Category-3: Any technical issues with the pump Category-4: Changes in the insulin solution in the infusion set or reservoir Category-5: High BG with no other explanation which made the subject change the infusion set Category-6: Infusion site reaction Category-7: Missing
Time frame: Week 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-3 | 23 Number of subjects |
| Faster Aspart | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-5 | 66 Number of subjects |
| Faster Aspart | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-2 | 108 Number of subjects |
| Faster Aspart | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-6 | 16 Number of subjects |
| Faster Aspart | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-4 | 3 Number of subjects |
| Faster Aspart | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-7 | 3 Number of subjects |
| Faster Aspart | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-1 | 50 Number of subjects |
| NovoRapid | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-7 | 1 Number of subjects |
| NovoRapid | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-1 | 50 Number of subjects |
| NovoRapid | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-2 | 75 Number of subjects |
| NovoRapid | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-3 | 17 Number of subjects |
| NovoRapid | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-4 | 8 Number of subjects |
| NovoRapid | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-5 | 60 Number of subjects |
| NovoRapid | Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets | Category-6 | 8 Number of subjects |
Secondary
Number of Treatment Emergent Adverse Events (AEs)
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 16. A TEAE was defined as an event that has an onset date on or after the first day of exposure to randomised treatment (in week 0), and no later than seven days after the last day of randomised treatment (i.e., maximum week 16 + 7 days). The results are based on the on-treatment period.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart | Number of Treatment Emergent Adverse Events (AEs) | 440 Number of adverse events |
| NovoRapid | Number of Treatment Emergent Adverse Events (AEs) | 412 Number of adverse events |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall
ADA classification of hypo: 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 hypo: 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 hypo.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis. The results are based on the on-treatment period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Probable symptomatic | 88 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: BG confirmed | 3258 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Asymptomatic | 2530 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed symptomatic | 2751 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Pseudo | 56 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed | 3279 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Documented symptomatic | 8372 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Unclassifiable | 7789 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Unclassifiable | 1 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes 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 According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Severe | 21 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes 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 According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Severe | 7 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Documented symptomatic | 8904 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Asymptomatic | 2273 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Probable symptomatic | 32 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Pseudo | 159 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | ADA: Unclassifiable | 0 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: BG confirmed | 3240 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed symptomatic | 2779 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed | 3247 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall | NN: Unclassifiable | 8128 Number of hypoglycaemic episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN 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.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | ADA: Probable symptomatic | 9 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | NN: BG confirmed | 482 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | ADA: Asymptomatic | 176 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | NN: Severe or BG confirmed symptomatic | 441 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | ADA: Pseudo | 7 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | NN: Severe or BG confirmed | 482 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | ADA: Documented symptomatic | 1258 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | NN: Unclassifiable | 968 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN 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 NN 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 NN Definition: Hypoglycaemic Episodes During First 2 Hours 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 NN 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 NN Definition: Hypoglycaemic Episodes During First 2 Hours 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 NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | ADA: Documented symptomatic | 1077 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | ADA: Asymptomatic | 175 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | ADA: Probable symptomatic | 6 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | ADA: Pseudo | 34 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN 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 NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | NN: BG confirmed | 413 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | NN: Severe or BG confirmed symptomatic | 372 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | NN: Severe or BG confirmed | 413 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal | NN: Unclassifiable | 879 Number of hypoglycaemic episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN 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.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | ADA: Probable symptomatic | 43 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | NN: BG confirmed | 1403 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | ADA: Asymptomatic | 750 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | NN: Severe or BG confirmed symptomatic | 1246 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | ADA: Pseudo | 29 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | NN: Severe or BG confirmed | 1408 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | ADA: Documented symptomatic | 3767 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | NN: Unclassifiable | 3186 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN 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 NN 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 NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | ADA: Severe | 5 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN 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 NN Definition: Hypoglycaemic Episodes During First 4 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 NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | ADA: Documented symptomatic | 3907 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | ADA: Asymptomatic | 677 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | ADA: Probable symptomatic | 17 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | ADA: Pseudo | 98 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN 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 NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | NN: BG confirmed | 1399 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | NN: Severe or BG confirmed symptomatic | 1259 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | NN: Severe or BG confirmed | 1401 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal | NN: Unclassifiable | 3300 Number of hypoglycaemic episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 1 hour to 2 hours after start of the meal. The results are based on the on-treatment period.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| 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 1 Hour to 2 Hours After Start of the Meal | ADA: Probable symptomatic | 8 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 1 Hour to 2 Hours After Start of the Meal | NN: BG confirmed | 390 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 1 Hour to 2 Hours After Start of the Meal | ADA: Asymptomatic | 145 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 1 Hour to 2 Hours After Start of the Meal | NN: Severe or BG confirmed symptomatic | 360 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 1 Hour to 2 Hours After Start of the Meal | ADA: Pseudo | 7 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 1 Hour to 2 Hours After Start of the Meal | NN: Severe or BG confirmed | 390 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 1 Hour to 2 Hours After Start of the Meal | ADA: Documented symptomatic | 1034 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 1 Hour to 2 Hours After Start of the Meal | NN: Unclassifiable | 804 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 1 Hour to 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 NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 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 NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours 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 NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 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 NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours 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 NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal | ADA: Documented symptomatic | 887 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal | ADA: Asymptomatic | 142 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal | ADA: Probable symptomatic | 3 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal | ADA: Pseudo | 29 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 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 NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal | NN: BG confirmed | 362 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal | NN: Severe or BG confirmed symptomatic | 324 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal | NN: Severe or BG confirmed | 362 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal | NN: Unclassifiable | 699 Number of hypoglycaemic episodes |
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.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| 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: Probable symptomatic | 34 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 | 921 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 | 574 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 | 805 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 | 22 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 | 926 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 | 2509 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 | 2218 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 | 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 | ADA: Severe | 5 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: Severe | 2 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 | 2830 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 | 502 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 | 11 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 | 64 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 | NN: BG confirmed | 986 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 | 887 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 | 988 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 | 2421 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.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| 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 | 70 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 | 2799 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 | 2321 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 | 2335 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 | 52 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 | 2811 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 | 7508 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 | 7152 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 | 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) | 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 | 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) | 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 | 5 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 | 7889 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 | 2071 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 | 26 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 | 144 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 | 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) | NN: BG confirmed | 2769 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 | 2359 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 | 2774 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 | 7361 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.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| 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 | 1 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 | 92 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 | 31 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 | 81 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 | 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 | NN: Severe or BG confirmed | 92 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 | 224 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 | 164 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 | 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 | 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 | 190 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 | 33 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 | 3 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 | 5 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 | 51 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 | 48 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 | 51 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 | 180 Number of hypoglycaemic episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 3 hours after start of the meal. The results are based on the on-treatment period.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| 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 Occurring Between 2 to 3 Hours After Start of the Meal | ADA: Probable symptomatic | 19 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | NN: BG confirmed | 491 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | ADA: Asymptomatic | 277 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | NN: Severe or BG confirmed symptomatic | 429 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | ADA: Pseudo | 13 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | NN: Severe or BG confirmed | 493 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | ADA: Documented symptomatic | 1327 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | NN: Unclassifiable | 1145 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 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 Occurring Between 2 to 3 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 Occurring Between 2 to 3 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 Occurring Between 2 to 3 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 Occurring Between 2 to 3 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 Occurring Between 2 to 3 Hours After Start of the Meal | ADA: Documented symptomatic | 1518 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | ADA: Asymptomatic | 241 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | ADA: Probable symptomatic | 7 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | ADA: Pseudo | 38 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 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 Occurring Between 2 to 3 Hours After Start of the Meal | NN: BG confirmed | 555 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | NN: Severe or BG confirmed symptomatic | 508 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | NN: Severe or BG confirmed | 556 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal | NN: Unclassifiable | 1249 Number of hypoglycaemic episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 3 to 4 hours after start of the meal. The results are based on the on-treatment period.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| 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 Occurring Between 3 to 4 Hours After Start of the Meal | ADA: Probable symptomatic | 15 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | NN: BG confirmed | 430 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | ADA: Asymptomatic | 297 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 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 Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | ADA: Pseudo | 9 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | NN: Severe or BG confirmed | 433 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | ADA: Documented symptomatic | 1182 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | NN: Unclassifiable | 1073 Number of hypoglycaemic episodes |
| Faster Aspart | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 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 Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 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 Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | ADA: Severe | 3 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 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 Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 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 Occurring Between 3 to 4 Hours After Start of the Meal | ADA: Documented symptomatic | 1312 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | ADA: Asymptomatic | 261 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | 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: Hypoglycaemic Episodes Occurring Between 3 to 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 Occurring Between 3 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 Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | NN: BG confirmed | 431 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | NN: Severe or BG confirmed symptomatic | 379 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | NN: Severe or BG confirmed | 432 Number of hypoglycaemic episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal | NN: Unclassifiable | 1172 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.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| 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: Unclassifiable | 1 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 | 459 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 | 864 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 | 416 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: Probable symptomatic | 18 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 | 468 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 | 9 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 | 637 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) | 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: Asymptomatic | 209 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 | 1015 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 | 202 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 | 6 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 | 15 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 | 471 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 | 420 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 | 473 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 | 767 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 |
Secondary
Number of Treatment Emergent Infusion Site Reactions
Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart | Number of Treatment Emergent Infusion Site Reactions | 44 Number of infusion site reaction events |
| NovoRapid | Number of Treatment Emergent Infusion Site Reactions | 32 Number of infusion site reaction events |
Secondary
Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)
Unexplained hyperglycaemia was defined as a confirmed PG value ≥16.7 mmol/L (300 mg/dL) and was unexplained (i.e. no apparent medical, dietary, insulin dosage or pump failure reason). The results are based on the on-treatment period.
Time frame: Weeks 0-16
Population: The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart | Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG) | 1185 Number of hypoglycaemic episodes |
| NovoRapid | Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG) | 1058 Number of hypoglycaemic episodes |
Secondary
Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)
Percentage of subjects reaching HbA1c \<7.0% (53 mmol/mol) was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.
Time frame: Week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart | Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) | 20.3 % of subjects |
| NovoRapid | Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) | 23.3 % of subjects |
Secondary
Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes
Percentage of subjects reaching HbA1c \<7.0% (53 mmol/mol) without treatment emergent severe hypoglycaemic episodes was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of IMP administration after randomisation (in week 0) and no later than one day after the last day on IMP (i.e., maximum week 16 + 1 day). The results are based on the in-trial period.
Time frame: Week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart | Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes | 18.6 % of subjects |
| NovoRapid | Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes | 22.5 % of subjects |
Secondary
Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]
Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L \[140 mg/dL\] was evaluated after 16 weeks of randomisation. Subjects 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 in-trial period.
Time frame: Week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart | Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] | 8.1 % of subjects |
| NovoRapid | Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] | 7.6 % of subjects |
Secondary
Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia
Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L \[140 mg/dL\] without treatment emergent severe hypoglycaemia was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. The results are based on the in-trial period.
Time frame: Week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart | Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia | 7.6 % of subjects |
| NovoRapid | Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia | 6.8 % of subjects |
Secondary
Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])
Percentage of time spent with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L \[45, 54, 63, 70 mg/dL\]) and IG \>10.0, 12.0, 13.9 mmol/L \[180, 216, 250 mg/dL\]) 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.
Time frame: Week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.5 mmol/L (63 mg/dL) | 3.75 % of time | Standard Deviation 2.85 |
| Faster Aspart | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >10.0 mmol/L (180 mg/dL) | 41.57 % of time | Standard Deviation 13.09 |
| Faster Aspart | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.0 mmol/L (54 mg/dL) | 2.15 % of time | Standard Deviation 1.98 |
| Faster Aspart | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >12.0 mmol/L (216 mg/dL) | 26.34 % of time | Standard Deviation 11.66 |
| Faster Aspart | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.9 mmol/L (70.2 mg/dL) | 5.46 % of time | Standard Deviation 3.68 |
| Faster Aspart | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >13.9 mmol/L (250 mg/dL) | 15.87 % of time | Standard Deviation 9.42 |
| Faster Aspart | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤2.5 mmol/L (45 mg/dL) | 1.11 % of time | Standard Deviation 1.29 |
| NovoRapid | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >13.9 mmol/L (250 mg/dL) | 14.23 % of time | Standard Deviation 8.49 |
| NovoRapid | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤2.5 mmol/L (45 mg/dL) | 1.03 % of time | Standard Deviation 1.38 |
| NovoRapid | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.0 mmol/L (54 mg/dL) | 2.19 % of time | Standard Deviation 2.25 |
| NovoRapid | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.5 mmol/L (63 mg/dL) | 3.93 % of time | Standard Deviation 3.37 |
| NovoRapid | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG ≤3.9 mmol/L (70.2 mg/dL) | 5.76 % of time | Standard Deviation 4.25 |
| NovoRapid | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >10.0 mmol/L (180 mg/dL) | 39.24 % of time | Standard Deviation 11.86 |
| NovoRapid | Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) | IG >12.0 mmol/L (216 mg/dL) | 24.23 % of time | Standard Deviation 10.75 |
Secondary
Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL)
Percentage of time spent within IG target range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) 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.
Time frame: Week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart | Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) | IG 4.0-7.8 mmol/L (71-140 mg/dL) | 31.49 % of time | Standard Deviation 9.97 |
| Faster Aspart | Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) | IG 4.0-10.0 mmol/L (71-180 mg/dL) | 52.40 % of time | Standard Deviation 11.87 |
| NovoRapid | Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) | IG 4.0-7.8 mmol/L (71-140 mg/dL) | 33.11 % of time | Standard Deviation 8.76 |
| NovoRapid | Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) | IG 4.0-10.0 mmol/L (71-180 mg/dL) | 54.40 % of time | Standard Deviation 10.7 |
Secondary
Variation in the IG Profile
Variation in IG profile was the average absolute difference from the mean of the IG profile. Variation in the IG 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.
Time frame: Week 16
Population: The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Faster Aspart | Variation in the IG Profile | 3.09 mmol/L |
| NovoRapid | Variation in the IG Profile | 3.04 mmol/L |