Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.
Interventions
DRUGFaster-acting insulin aspart
For subcutaneous (s.c., under the skin) injection once daily.
DRUGinsulin aspart
For subcutaneous (s.c., under the skin) injection once daily.
DRUGinsulin degludec
For subcutaneous (s.c., under the skin) injection once daily.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
- Male or female, 1 year above or equal to age below 18 years at the time of signing informed consent and below 18 years at the time of randomisation - Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) - Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or Neutral Protamine Hagedorn (NPH) insulin for at least 90 days prior to the screening visit - HbA1c (glycosylated haemoglobin) below or equal 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit
Exclusion criteria
- More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit - 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Percentage of HbA1c | Week 0, Week 26 | Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related participant-site contact and included data collected after a subject discontinued trial product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 1,5-anhydroglucitol | Week 0, Week 26 | Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value. |
| Change in 8-point SMPG Profile: PPG Increment Over All Three Meals | Week 0, Week 26 | Change from baseline (week 0) in mean PPG increment over all three meals was evaluated after 26 weeks of randomisation. Postprandial glucose (PPG) increment for each meal (breakfast, lunch and main evening meal) was derived from the 8-point profile as the difference between PPG (1 hour after the meal) values and the plasma glucose (PG) value before meal. The mean of the derived increments was then calculated separately for each meal. Mean PPG increment over all three meals was derived as the mean of all corresponding mean meal increments. The results are based on the last in-trial value. |
| Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Week 0, Week 26 | Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG was evaluated after 26 weeks of randomisation. PPG for each meal was recorded by the participant as part of the 8-point SMPG profile. The results are based on the last in-trial value. |
| Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Week 0, Week 26 | Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG increment was evaluated after 26 weeks of randomisation. PPG increment for each meal was derived from the 8-point profile as the difference between PPG values (1 hour after the meal) and the PG value before meal. The results are based on the last in-trial value. |
| Change in 8-point SMPG Profile: Mean of the 8-point Profile | Week 0, Week 26 | Change from baseline (week 0) in mean of the 8-point SMPG profile was evaluated after 26 weeks of randomisation. SMPG values were recorded at 8 time-points on two consecutive days: before and after (60 minute after the start of the meal) breakfast, lunch and main evening meal, before bedtime, and before breakfast on the next day. Mean of the 8-point profile was derived as the mean of all corresponding mean SMPG recorded at 8 different time points. The results are based on the last in-trial value. |
| Fluctuation in the 8-point SMPG Profile | Week 26 | Fluctuation in the 8-point SMPG profile was evaluated after 26 weeks of randomisation. Fluctuation in 8-point SMPG profile was the average absolute difference from the mean of the SMPG profile. The results are based on the last in-trial value. |
| Change in FPG | Week 0, Week 26 | Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value. |
| Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines | Week 26 | Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value. |
| Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia | Week 26 | Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to ISPAD guidelines, without severe hypoglycaemia was evaluated after 26 weeks of randomisation. Severe hypoglycaemia according to ISPAD guidelines: hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose). The results are based on the last in-trial value. |
| Insulin Dose (Units/Day): Total Basal | Week 26 | Total basal insulin dose (Units/day) was evaluated after 26 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 NovoRapid®/NovoLog® / faster aspart and no later than 7 days after the day of last dose of NovoRapid®/NovoLog® / faster aspart. The on-treatment observation period includes data collected up to and including 7 days after treatment discontinuation. Number of participants analysed = number of participants contributed to the analysis. Analysis population description: Safety analysis set (SAS) included all participants receiving at least one dose of the investigational product (faster aspart) or its comparator (NovoRapid®/NovoLog®). |
| Insulin Dose (Units/Day): Total Bolus | Week 26 | Total bolus insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Insulin Dose (Units/Day): Individual Meal Insulin Dose | Week 26 | Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. |
| Insulin Dose (Units/kg/Day): Total Basal | Week 26 | Total basal insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Insulin Dose (Units/kg/Day): Total Bolus | Week 26 | Total bolus insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Week 26 | Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL]) | Week 0, Week 26 | Change from baseline (week 0) in the time spent in low IG (\<=3.9 mmol/L \[70 mg/dL\]) based on continuous glucose monitoring (CGM) was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. |
| Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Week 26 | Incidence of episodes (number of episodes per 24 hours) with IG \<=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG \>10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was calculated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. |
| Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Week 26 | Percentage of time spent with IG \<=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG \>10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. |
| Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included | Week 26 | Percentage of time spent within IG target 4.0-10.0 mmol/L (71-180 mg/dL), both included based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. |
| Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | Week 0, Week 26 | Change from baseline (week 0) in mean IG increment (0-1 hours and 0-2 hours after start of the meal) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value. |
| Change in Mean IG Peak After Start of Meal | Week 0, Week 26 | Change from baseline (week 0) in mean IG peak after start of meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value. |
| Change in Mean Time to the IG Peak After Meal | Week 0, Week 26 | Change from baseline (week 0) in mean time to the IG peak after meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of subjects wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value. |
| Change in 30-minute PPG | Week 0, Week 26 | Change from baseline (week 0) in 30-minute PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 30-minute after the meal intake at the visit. The results are based on the last in-trial value. |
| Change in 30-minute PPG Increment | Week 0, Week 26 | Change from baseline (week 0) in 30-minute PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 30-minute (after the meal) at the visit. PPG increment was derived as 30-minute PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value. |
| Change in 1-hour PPG | Week 0, Week 26 | Change from baseline (week 0) in 1-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 1-hour after the meal intake at the visit. The results are based on the last in-trial value. |
| Change in 1-hour PPG Increment | Week 0, Week 26 | Change from baseline (week 0) in 1-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 1-hour (after the meal) at the visit. PPG increment was derived as 1-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value. |
| Change in 2-hour PPG | Week 0, Week 26 | Change from baseline (week 0) in 2-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 2-hour after the meal intake at the visit. The results are based on the last in-trial value. |
| Change in 2-hour PPG Increment | Week 0, Week 26 | Change from baseline (week 0) in 2-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 2-hour (after the meal) at the visit. PPG increment was derived as 2-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value. |
| Change in AUCIG,0-15min | Week 0, Week 26 | Change in area under the IG curve 0-15 minutes post meal (AUCIG,0-15min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. Interstitial glucose (IG) was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. |
| Change in AUCIG,0-30min | Week 0, Week 26 | Change in area under the IG curve 0-30 minutes post meal (AUCIG,0-30min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. |
| Change in AUCIG,0-1h | Week 0, Week 26 | Change in area under the IG curve 0-1 hour post meal (AUCIG,0-1h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. |
| Change in AUCIG,0-2h | Week 0, Week 26 | Change in area under the IG curve 0-2 hours post meal (AUCIG,0-2h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. |
| Change in AUCIG,0-4h | Week 0, Week 26 | Change in area under the IG curve 0-4 hours post meal (AUCIG,0-4h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value. |
| Change in Time to the IG Peak After Start of Meal | Week 0, Week 26 | Change in time to the IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value. |
| Change in IG Peak After Start of Meal | Week 0, Week 26 | Change in IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Week 0-26 | Treatment emergent: if the onset of the episode occurred on or after the first day of treatment with investigational medicinal product (IMP) after randomisation, and no later than 1 day after the last day on IMP. Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic: episode during which typical symptoms of hypoglycaemia are accompanied by a PG level ≤3.9 mmol/L. 3) Asymptomatic: episode not accompanied by typical symptoms of hypoglycaemia, but with a PG level ≤3.9 mmol/L. 4) Probable symptomatic: an episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG level ≤3.9 mmol/L. 5) Pseudo-hypoglycaemia: episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a PG level \>3.9mmol/L, but approaching that level. The results are based on the on-treatment period. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) Symptomatic blood glucose (BG) confirmed: episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3) Asymptomatic BG confirmed: episode that is BG confirmed by PG value \<3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG confirmed symptomatic: an episode that is severe according to the ISPAD classification or BG confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG confirmed: an episode that is BG confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG confirmed: an episode that is severe according to the ISPAD Classification or BG confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. The results are based on the on-treatment period. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period. |
| Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period. |
| Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period. |
| Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period. |
| Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period. |
| Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period. |
| Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period. |
| Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period. |
| Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period. |
| Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Week 0-26 | Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period. |
| Number of Treatment Emergent Adverse Events (AEs) | Week 0-26 | Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP (faster aspart or NovoRapid®/NovoLog®) and excluding the events occurring in the run-in period. The results are based on the on-treatment period. |
| Number of Treatment Emergent Injection Site Reactions | Week 0-26 | Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP and excluding the events occurring in the run-in period. The results are based on the on-treatment period. |
| Change in Physical Examination | Week 0, Week 26 | The following physical examinations were done: 1) Cardiovascular system. 2) Central and peripheral nervous system. 3) Gastrointestinal system including the mouth. 4) General appearance. 5) Head, ears, eyes, nose, throat and neck. 6) Musculoskeletal system. 7) Respiratory system. 8) Skin. Presented results are number of participants with the following outcomes: normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS). Presented results are baseline (week 0) and last on-treatment values. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Vital Sign: Blood Pressure | Week 0, Week 26 | Change from baseline (week 0) in blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. |
| Change in Vital Sign: Pulse | Week 0, Week 26 | Change from baseline (week 0) in pulse was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. |
| Change in Body Weight | Week 0, Week 26 | Change from baseline (week 0) in body weight was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Height | Week 0, Week 26 | Change from baseline (week 0) in height was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Body Mass Index | Week 0, Week 26 | Change from baseline (week 0) in body mass index (BMI) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in SD Score of Body Weight | Week 0, Week 26 | Change from baseline (week 0) in standard deviation (SD) score of body weight was evaluated after 26 weeks of randomisation. SD-scores are defined to be able to normalise the body weight in the various age groups. To estimate the growth of children, standardised weight is calculated for each year of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2. The SD scores are derived from the age and sex of the subjects and the body weight together with growth curves defined for a reference population. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in SD Score of Body Mass Index | Week 0, Week 26 | Change from baseline (week 0) in SD score of BMI was evaluated after 26 weeks of randomisation. SD scores for BMI were determined in a similar way as SD scores for weight by use of a suitable reference population based on age and sex. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Haematology: Haemoglobin | Week 0, Week 26 | Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Haematology: Haematocrit | Week 0, Week 26 | Change from baseline (week 0) in haematocrit was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Haematology: Erythrocytes | Week 0, Week 26 | Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Haematology: Thrombocytes | Week 0, Week 26 | Change from baseline (week 0) in thrombocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Haematology: Leukocytes | Week 0, Week 26 | Change from baseline (week 0) in leukocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Biochemistry: Creatinine | Week 0, Week 26 | Change from baseline (week 0) in creatinine was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Biochemistry: Alanine Aminotransferase (ALT) | Week 0, Week 26 | Change from baseline (week 0) in ALT was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Biochemistry: Aspartate Aminotransferase (AST) | Week 0, Week 26 | Change from baseline (week 0) in AST was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Biochemistry: Alkaline Phosphatase (AP) | Week 0, Week 26 | Change from baseline (week 0) in AP was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in 8-point SMPG Profile: Mean PPG Over All Three Meals | Week 0, Week 26 | Change from baseline (week 0) in mean post prandial glucose (PPG) over all three meals was evaluated after 26 weeks of randomisation. PPG for each meal (breakfast, lunch and main evening meal) was recorded by the participant as part of the 8-point self-measured plasma glucose (SMPG) profile. Mean PPG over all three meals was derived as the mean of all corresponding mean meal. The results are based on the last in-trial value. |
| Change in Biochemistry: Potassium | Week 0, Week 26 | Change from baseline (week 0) in potassium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Biochemistry: Albumin | Week 0, Week 26 | Change from baseline (week 0) in albumin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Biochemistry: Total Bilirubin | Week 0, Week 26 | Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
| Change in Lipid Profile: Total Cholesterol | Week 0, Week 26 | Change from baseline (week 0) in total cholesterol after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value. |
| Change in Lipid Profile: High Density Lipoproteins (HDL) | Week 0, Week 26 | Change from baseline (week 0) in HDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value. |
| Change in Lipid Profile: Low Density Lipoproteins (LDL) | Week 0, Week 26 | Change from baseline (week 0) in LDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value. |
| Change in Anti-insulin Aspart Antibody Development: Specific | Week 0, Week 26 | Change from baseline (week 0) in 'antibodies specific for insulin aspart' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value. |
| Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin | Week 0, Week 26 | Change from baseline (week 0) in 'antibodies for insulin aspart, those cross-reacting with human insulin' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value. |
| Change in Anti-insulin Aspart Antibody Development: Total | Week 0, Week 26 | Change from baseline (week 0) in 'total anti-insulin aspart antibodies (specific for insulin aspart and those cross-reacting with human insulin)' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value. |
| Change in Biochemistry: Sodium | Week 0, Week 26 | Change from baseline (week 0) in sodium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis. |
Countries
Bulgaria, Czechia, Estonia, Finland, Germany, India, Israel, Italy, Japan, Latvia, Lithuania, Poland, Puerto Rico, Russia, Serbia, Turkey (Türkiye), Ukraine, United States
Participant flow
Recruitment details
The trial was conducted at 150 sites in 17 countries(number of sites with screened/randomised subjects)-Bulgaria: 4/4; Czech Republic: 6/6; Estonia: 2/2; Finland: 3/3; Germany: 6/6; India: 7/7; Israel: 6/6; Italy: 5/5; Japan: 34/34; Latvia: 1/1; Lithuania: 1/1; Poland: 4/4; Russia: 11/11; Serbia: 4/4; Turkey: 7/7; Ukraine: 9/9; United States: 40/39
Pre-assignment details
12-week run-in period: Participants were switched from previous insulin treatment to insulin degludec once daily, and mealtime NovoRapid®/NovoLog®. Insulin degludec treatment was optimised on a weekly basis to the pre-breakfast glycaemic target of 4.0-8.0 mmol/L. Out of 834 participants, who started the run-in period, 57 were run-in failures.
Participants by arm
| Arm | Count |
|---|---|
| Faster Aspart (Meal) Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed. | 260 |
| Faster Aspart (Post) Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (20 minutes after the start of the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the premeal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed. | 259 |
| NovoRapid (Meal) Bolus insulin: After 12-week run-in period, participants continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during the 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the pre-meal target of 4.0-8.0 mmol/L, and the bed-time target of 6.7-10 mmol/L in a treat-to-target fashion. Basal insulin: Participants continued insulin degludec once daily s.c. injections from the dose optimization process during the 12-week run-in period till 26-week treatment period. Dose adjustment during the treatment period at the discretion of the investigator was allowed if needed. | 258 |
| Total | 777 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Unclassified | 0 | 3 | 0 |
| Overall Study | Withdrawal by parent/guardian | 4 | 4 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 4 |
Baseline characteristics
| Characteristic | Faster Aspart (Meal) | Faster Aspart (Post) | NovoRapid (Meal) | Total |
|---|---|---|---|---|
| Age, Continuous | 11.72 Years STANDARD_DEVIATION 3.74 | 11.62 Years STANDARD_DEVIATION 3.65 | 11.70 Years STANDARD_DEVIATION 3.44 | 11.68 Years STANDARD_DEVIATION 3.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 17 Participants | 12 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 244 Participants | 242 Participants | 246 Participants | 732 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 46 Participants | 37 Participants | 43 Participants | 126 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 5 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 206 Participants | 217 Participants | 209 Participants | 632 Participants |
| Sex: Female, Male Female | 126 Participants | 122 Participants | 110 Participants | 358 Participants |
| Sex: Female, Male Male | 134 Participants | 137 Participants | 148 Participants | 419 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 261 | 0 / 258 | 0 / 258 |
| other Total, other adverse events | 137 / 261 | 149 / 258 | 136 / 258 |
| serious Total, serious adverse events | 5 / 261 | 13 / 258 | 9 / 258 |
Outcome results
Primary
Change in the Percentage of HbA1c
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related participant-site contact and included data collected after a subject discontinued trial product.
Time frame: Week 0, Week 26
Population: Full analysis set (FAS), which included all randomised participants. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in the Percentage of HbA1c | Change from baseline | 0.06 Percentage of HbA1c | Standard Deviation 0.8 |
| Faster Aspart (Meal) | Change in the Percentage of HbA1c | Baseline | 7.57 Percentage of HbA1c | Standard Deviation 0.8 |
| Faster Aspart (Post) | Change in the Percentage of HbA1c | Change from baseline | 0.33 Percentage of HbA1c | Standard Deviation 0.83 |
| Faster Aspart (Post) | Change in the Percentage of HbA1c | Baseline | 7.58 Percentage of HbA1c | Standard Deviation 0.84 |
| NovoRapid (Meal) | Change in the Percentage of HbA1c | Baseline | 7.53 Percentage of HbA1c | Standard Deviation 0.83 |
| NovoRapid (Meal) | Change in the Percentage of HbA1c | Change from baseline | 0.23 Percentage of HbA1c | Standard Deviation 0.82 |
Comparison: The primary analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value (s) imputed from the available information from the treatment the participant had been randomised to.p-value: <0.00195% CI: [-0.3, -0.03]Multiple imputation
Comparison: The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.p-value: <0.00195% CI: [-0.01, 0.26]Multiple imputation
Comparison: The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.p-value: =0.00795% CI: [-0.3, -0.03]multiple imputation
Secondary
Change in 1,5-anhydroglucitol
Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 1,5-anhydroglucitol | Baseline | 4.95 ug/mL | Standard Deviation 3.62 |
| Faster Aspart (Meal) | Change in 1,5-anhydroglucitol | Change from baseline | -0.06 ug/mL | Standard Deviation 3.13 |
| Faster Aspart (Post) | Change in 1,5-anhydroglucitol | Change from baseline | -0.85 ug/mL | Standard Deviation 2.8 |
| Faster Aspart (Post) | Change in 1,5-anhydroglucitol | Baseline | 5.07 ug/mL | Standard Deviation 3.97 |
| NovoRapid (Meal) | Change in 1,5-anhydroglucitol | Baseline | 5.13 ug/mL | Standard Deviation 3.76 |
| NovoRapid (Meal) | Change in 1,5-anhydroglucitol | Change from baseline | -0.63 ug/mL | Standard Deviation 2.42 |
Secondary
Change in 1-hour PPG
Change from baseline (week 0) in 1-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 1-hour after the meal intake at the visit. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 1-hour PPG | Baseline | 12.77 mmol/L | Standard Deviation 3.92 |
| Faster Aspart (Meal) | Change in 1-hour PPG | Change from baseline | -0.15 mmol/L | Standard Deviation 4.39 |
| Faster Aspart (Post) | Change in 1-hour PPG | Baseline | 12.56 mmol/L | Standard Deviation 5.08 |
| Faster Aspart (Post) | Change in 1-hour PPG | Change from baseline | 2.54 mmol/L | Standard Deviation 4.43 |
| NovoRapid (Meal) | Change in 1-hour PPG | Baseline | 13.06 mmol/L | Standard Deviation 3.86 |
| NovoRapid (Meal) | Change in 1-hour PPG | Change from baseline | -0.63 mmol/L | Standard Deviation 4.73 |
Secondary
Change in 1-hour PPG Increment
Change from baseline (week 0) in 1-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 1-hour (after the meal) at the visit. PPG increment was derived as 1-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 1-hour PPG Increment | Baseline | 4.93 mmol/L | Standard Deviation 3.34 |
| Faster Aspart (Meal) | Change in 1-hour PPG Increment | Change from baseline | 0.42 mmol/L | Standard Deviation 4.93 |
| Faster Aspart (Post) | Change in 1-hour PPG Increment | Baseline | 5.08 mmol/L | Standard Deviation 4.21 |
| Faster Aspart (Post) | Change in 1-hour PPG Increment | Change from baseline | 2.63 mmol/L | Standard Deviation 4.03 |
| NovoRapid (Meal) | Change in 1-hour PPG Increment | Baseline | 5.36 mmol/L | Standard Deviation 2.77 |
| NovoRapid (Meal) | Change in 1-hour PPG Increment | Change from baseline | -0.52 mmol/L | Standard Deviation 3.17 |
Secondary
Change in 2-hour PPG
Change from baseline (week 0) in 2-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 2-hour after the meal intake at the visit. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 2-hour PPG | Baseline | 12.50 mmol/L | Standard Deviation 4.63 |
| Faster Aspart (Meal) | Change in 2-hour PPG | Change from baseline | 0.69 mmol/L | Standard Deviation 5.88 |
| Faster Aspart (Post) | Change in 2-hour PPG | Baseline | 12.54 mmol/L | Standard Deviation 5.74 |
| Faster Aspart (Post) | Change in 2-hour PPG | Change from baseline | 1.80 mmol/L | Standard Deviation 5.08 |
| NovoRapid (Meal) | Change in 2-hour PPG | Baseline | 12.37 mmol/L | Standard Deviation 4.74 |
| NovoRapid (Meal) | Change in 2-hour PPG | Change from baseline | -0.75 mmol/L | Standard Deviation 5.64 |
Secondary
Change in 2-hour PPG Increment
Change from baseline (week 0) in 2-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 2-hour (after the meal) at the visit. PPG increment was derived as 2-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 2-hour PPG Increment | Baseline | 4.66 mmol/L | Standard Deviation 4.22 |
| Faster Aspart (Meal) | Change in 2-hour PPG Increment | Change from baseline | 1.26 mmol/L | Standard Deviation 6.81 |
| Faster Aspart (Post) | Change in 2-hour PPG Increment | Baseline | 5.06 mmol/L | Standard Deviation 5.04 |
| Faster Aspart (Post) | Change in 2-hour PPG Increment | Change from baseline | 1.62 mmol/L | Standard Deviation 5.03 |
| NovoRapid (Meal) | Change in 2-hour PPG Increment | Baseline | 4.67 mmol/L | Standard Deviation 3.83 |
| NovoRapid (Meal) | Change in 2-hour PPG Increment | Change from baseline | -0.64 mmol/L | Standard Deviation 4.43 |
Secondary
Change in 30-minute PPG
Change from baseline (week 0) in 30-minute PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 30-minute after the meal intake at the visit. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 30-minute PPG | Baseline | 11.28 mmol/L | Standard Deviation 3.26 |
| Faster Aspart (Meal) | Change in 30-minute PPG | Change from baseline | -0.21 mmol/L | Standard Deviation 3.49 |
| Faster Aspart (Post) | Change in 30-minute PPG | Baseline | 10.96 mmol/L | Standard Deviation 3.78 |
| Faster Aspart (Post) | Change in 30-minute PPG | Change from baseline | 1.84 mmol/L | Standard Deviation 3.41 |
| NovoRapid (Meal) | Change in 30-minute PPG | Baseline | 11.71 mmol/L | Standard Deviation 3.13 |
| NovoRapid (Meal) | Change in 30-minute PPG | Change from baseline | -0.45 mmol/L | Standard Deviation 3.42 |
Secondary
Change in 30-minute PPG Increment
Change from baseline (week 0) in 30-minute PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 30-minute (after the meal) at the visit. PPG increment was derived as 30-minute PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 30-minute PPG Increment | Baseline | 3.44 mmol/L | Standard Deviation 2.16 |
| Faster Aspart (Meal) | Change in 30-minute PPG Increment | Change from baseline | 0.36 mmol/L | Standard Deviation 2.92 |
| Faster Aspart (Post) | Change in 30-minute PPG Increment | Baseline | 3.48 mmol/L | Standard Deviation 2.5 |
| Faster Aspart (Post) | Change in 30-minute PPG Increment | Change from baseline | 1.92 mmol/L | Standard Deviation 2.79 |
| NovoRapid (Meal) | Change in 30-minute PPG Increment | Baseline | 4.02 mmol/L | Standard Deviation 2.18 |
| NovoRapid (Meal) | Change in 30-minute PPG Increment | Change from baseline | -0.34 mmol/L | Standard Deviation 2.18 |
Secondary
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG
Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG was evaluated after 26 weeks of randomisation. PPG for each meal was recorded by the participant as part of the 8-point SMPG profile. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Breakfast: Baseline | 10.51 mmol/L | Standard Deviation 3.59 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Breakfast: Change from baseline | -1.11 mmol/L | Standard Deviation 3.91 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Lunch: Baseline | 9.69 mmol/L | Standard Deviation 3.32 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Lunch: Change from baseline | -0.80 mmol/L | Standard Deviation 3.74 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Main evening meal: Baseline | 10.24 mmol/L | Standard Deviation 3.64 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Main evening meal: Change from baseline | -0.74 mmol/L | Standard Deviation 3.96 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Main evening meal: Change from baseline | 0.61 mmol/L | Standard Deviation 4.4 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Breakfast: Baseline | 10.51 mmol/L | Standard Deviation 3.77 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Lunch: Change from baseline | 0.18 mmol/L | Standard Deviation 4.4 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Main evening meal: Baseline | 9.90 mmol/L | Standard Deviation 3.59 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Breakfast: Change from baseline | 0.16 mmol/L | Standard Deviation 3.95 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Lunch: Baseline | 9.99 mmol/L | Standard Deviation 3.82 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Breakfast: Change from baseline | 0.04 mmol/L | Standard Deviation 3.89 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Lunch: Baseline | 9.62 mmol/L | Standard Deviation 3.3 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Main evening meal: Change from baseline | -0.05 mmol/L | Standard Deviation 4.14 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Lunch: Change from baseline | -0.24 mmol/L | Standard Deviation 4.22 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Breakfast: Baseline | 10.49 mmol/L | Standard Deviation 3.59 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG | Main evening meal: Baseline | 9.87 mmol/L | Standard Deviation 3.46 |
Secondary
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment
Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG increment was evaluated after 26 weeks of randomisation. PPG increment for each meal was derived from the 8-point profile as the difference between PPG values (1 hour after the meal) and the PG value before meal. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Breakfast: Baseline | 1.90 mmol/L | Standard Deviation 3.64 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Breakfast: Change from baseline | -0.82 mmol/L | Standard Deviation 4.44 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Lunch: Baseline | 1.02 mmol/L | Standard Deviation 3.82 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Lunch: Change from baseline | -0.58 mmol/L | Standard Deviation 4.92 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Main evening meal: Baseline | 0.53 mmol/L | Standard Deviation 4.28 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Main evening meal: Change from baseline | -0.92 mmol/L | Standard Deviation 5.07 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Main evening meal: Change from baseline | 1.03 mmol/L | Standard Deviation 4.68 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Breakfast: Baseline | 2.10 mmol/L | Standard Deviation 3.59 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Lunch: Change from baseline | 0.12 mmol/L | Standard Deviation 4.41 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Main evening meal: Baseline | -0.26 mmol/L | Standard Deviation 3.53 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Breakfast: Change from baseline | 0.46 mmol/L | Standard Deviation 4.21 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Lunch: Baseline | 1.12 mmol/L | Standard Deviation 3.79 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Breakfast: Change from baseline | 0.10 mmol/L | Standard Deviation 4.66 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Lunch: Baseline | 0.74 mmol/L | Standard Deviation 3.88 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Main evening meal: Change from baseline | 0.45 mmol/L | Standard Deviation 4.31 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Lunch: Change from baseline | -0.11 mmol/L | Standard Deviation 4.54 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Breakfast: Baseline | 2.12 mmol/L | Standard Deviation 4.08 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment | Main evening meal: Baseline | -0.06 mmol/L | Standard Deviation 3.78 |
Secondary
Change in 8-point SMPG Profile: Mean of the 8-point Profile
Change from baseline (week 0) in mean of the 8-point SMPG profile was evaluated after 26 weeks of randomisation. SMPG values were recorded at 8 time-points on two consecutive days: before and after (60 minute after the start of the meal) breakfast, lunch and main evening meal, before bedtime, and before breakfast on the next day. Mean of the 8-point profile was derived as the mean of all corresponding mean SMPG recorded at 8 different time points. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Mean of the 8-point Profile | Baseline | 9.41 mmol/L | Standard Deviation 1.98 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Mean of the 8-point Profile | Change from baseline | -0.27 mmol/L | Standard Deviation 2.04 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Mean of the 8-point Profile | Baseline | 9.47 mmol/L | Standard Deviation 1.89 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Mean of the 8-point Profile | Change from baseline | 0.17 mmol/L | Standard Deviation 2.12 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Mean of the 8-point Profile | Baseline | 9.39 mmol/L | Standard Deviation 1.97 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Mean of the 8-point Profile | Change from baseline | -0.05 mmol/L | Standard Deviation 2.29 |
Secondary
Change in 8-point SMPG Profile: Mean PPG Over All Three Meals
Change from baseline (week 0) in mean post prandial glucose (PPG) over all three meals was evaluated after 26 weeks of randomisation. PPG for each meal (breakfast, lunch and main evening meal) was recorded by the participant as part of the 8-point self-measured plasma glucose (SMPG) profile. Mean PPG over all three meals was derived as the mean of all corresponding mean meal. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Mean PPG Over All Three Meals | Baseline | 10.19 mmol/L | Standard Deviation 2.64 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: Mean PPG Over All Three Meals | Change from baseline | -0.94 mmol/L | Standard Deviation 2.55 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Mean PPG Over All Three Meals | Baseline | 10.12 mmol/L | Standard Deviation 2.79 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: Mean PPG Over All Three Meals | Change from baseline | 0.36 mmol/L | Standard Deviation 3.17 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Mean PPG Over All Three Meals | Baseline | 10.03 mmol/L | Standard Deviation 2.52 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: Mean PPG Over All Three Meals | Change from baseline | -0.21 mmol/L | Standard Deviation 2.79 |
Secondary
Change in 8-point SMPG Profile: PPG Increment Over All Three Meals
Change from baseline (week 0) in mean PPG increment over all three meals was evaluated after 26 weeks of randomisation. Postprandial glucose (PPG) increment for each meal (breakfast, lunch and main evening meal) was derived from the 8-point profile as the difference between PPG (1 hour after the meal) values and the plasma glucose (PG) value before meal. The mean of the derived increments was then calculated separately for each meal. Mean PPG increment over all three meals was derived as the mean of all corresponding mean meal increments. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis. .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: PPG Increment Over All Three Meals | Baseline | 1.20 mmol/L | Standard Deviation 2.7 |
| Faster Aspart (Meal) | Change in 8-point SMPG Profile: PPG Increment Over All Three Meals | Change from baseline | -0.92 mmol/L | Standard Deviation 2.92 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: PPG Increment Over All Three Meals | Baseline | 1.01 mmol/L | Standard Deviation 2.48 |
| Faster Aspart (Post) | Change in 8-point SMPG Profile: PPG Increment Over All Three Meals | Change from baseline | 0.56 mmol/L | Standard Deviation 2.88 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: PPG Increment Over All Three Meals | Baseline | 0.97 mmol/L | Standard Deviation 2.55 |
| NovoRapid (Meal) | Change in 8-point SMPG Profile: PPG Increment Over All Three Meals | Change from baseline | 0.14 mmol/L | Standard Deviation 2.75 |
Secondary
Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin
Change from baseline (week 0) in 'antibodies for insulin aspart, those cross-reacting with human insulin' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin | Baseline | 18.794 Percentage of B/T | Standard Deviation 17.189 |
| Faster Aspart (Meal) | Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin | Change from baseline | -3.202 Percentage of B/T | Standard Deviation 6.989 |
| Faster Aspart (Post) | Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin | Baseline | 21.576 Percentage of B/T | Standard Deviation 17.721 |
| Faster Aspart (Post) | Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin | Change from baseline | -4.845 Percentage of B/T | Standard Deviation 7.034 |
| NovoRapid (Meal) | Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin | Baseline | 20.156 Percentage of B/T | Standard Deviation 17.315 |
| NovoRapid (Meal) | Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin | Change from baseline | -3.802 Percentage of B/T | Standard Deviation 7.587 |
Secondary
Change in Anti-insulin Aspart Antibody Development: Specific
Change from baseline (week 0) in 'antibodies specific for insulin aspart' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Anti-insulin Aspart Antibody Development: Specific | Baseline | 1.436 Percentage of B/T | Standard Deviation 3.159 |
| Faster Aspart (Meal) | Change in Anti-insulin Aspart Antibody Development: Specific | Change from baseline | -0.099 Percentage of B/T | Standard Deviation 1.015 |
| Faster Aspart (Post) | Change in Anti-insulin Aspart Antibody Development: Specific | Baseline | 1.459 Percentage of B/T | Standard Deviation 5.313 |
| Faster Aspart (Post) | Change in Anti-insulin Aspart Antibody Development: Specific | Change from baseline | -0.213 Percentage of B/T | Standard Deviation 1.661 |
| NovoRapid (Meal) | Change in Anti-insulin Aspart Antibody Development: Specific | Baseline | 1.183 Percentage of B/T | Standard Deviation 2.134 |
| NovoRapid (Meal) | Change in Anti-insulin Aspart Antibody Development: Specific | Change from baseline | -0.201 Percentage of B/T | Standard Deviation 1.238 |
Secondary
Change in Anti-insulin Aspart Antibody Development: Total
Change from baseline (week 0) in 'total anti-insulin aspart antibodies (specific for insulin aspart and those cross-reacting with human insulin)' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Anti-insulin Aspart Antibody Development: Total | Baseline | 20.230 Percentage of B/T | Standard Deviation 17.795 |
| Faster Aspart (Meal) | Change in Anti-insulin Aspart Antibody Development: Total | Change from baseline | -3.271 Percentage of B/T | Standard Deviation 7.158 |
| Faster Aspart (Post) | Change in Anti-insulin Aspart Antibody Development: Total | Baseline | 23.044 Percentage of B/T | Standard Deviation 18.07 |
| Faster Aspart (Post) | Change in Anti-insulin Aspart Antibody Development: Total | Change from baseline | -5.061 Percentage of B/T | Standard Deviation 7.193 |
| NovoRapid (Meal) | Change in Anti-insulin Aspart Antibody Development: Total | Baseline | 21.344 Percentage of B/T | Standard Deviation 17.825 |
| NovoRapid (Meal) | Change in Anti-insulin Aspart Antibody Development: Total | Change from baseline | -4.004 Percentage of B/T | Standard Deviation 7.7 |
Secondary
Change in AUCIG,0-15min
Change in area under the IG curve 0-15 minutes post meal (AUCIG,0-15min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. Interstitial glucose (IG) was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in AUCIG,0-15min | Baseline | 8.01 mmol/L | Standard Deviation 2.72 |
| Faster Aspart (Meal) | Change in AUCIG,0-15min | Change from baseline | -1.27 mmol/L | Standard Deviation 3.68 |
| Faster Aspart (Post) | Change in AUCIG,0-15min | Baseline | 7.49 mmol/L | Standard Deviation 2.07 |
| Faster Aspart (Post) | Change in AUCIG,0-15min | Change from baseline | 0.08 mmol/L | Standard Deviation 2.48 |
| NovoRapid (Meal) | Change in AUCIG,0-15min | Baseline | 7.66 mmol/L | Standard Deviation 1.96 |
| NovoRapid (Meal) | Change in AUCIG,0-15min | Change from baseline | -0.53 mmol/L | Standard Deviation 2.85 |
Secondary
Change in AUCIG,0-1h
Change in area under the IG curve 0-1 hour post meal (AUCIG,0-1h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in AUCIG,0-1h | Baseline | 9.63 mmol/L | Standard Deviation 2.9 |
| Faster Aspart (Meal) | Change in AUCIG,0-1h | Change from baseline | -0.87 mmol/L | Standard Deviation 3.71 |
| Faster Aspart (Post) | Change in AUCIG,0-1h | Baseline | 9.43 mmol/L | Standard Deviation 2.71 |
| Faster Aspart (Post) | Change in AUCIG,0-1h | Change from baseline | 0.54 mmol/L | Standard Deviation 3 |
| NovoRapid (Meal) | Change in AUCIG,0-1h | Baseline | 10.02 mmol/L | Standard Deviation 2.19 |
| NovoRapid (Meal) | Change in AUCIG,0-1h | Change from baseline | -0.65 mmol/L | Standard Deviation 2.91 |
Secondary
Change in AUCIG,0-2h
Change in area under the IG curve 0-2 hours post meal (AUCIG,0-2h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in AUCIG,0-2h | Baseline | 11.40 mmol/L | Standard Deviation 3.2 |
| Faster Aspart (Meal) | Change in AUCIG,0-2h | Change from baseline | -0.84 mmol/L | Standard Deviation 3.93 |
| Faster Aspart (Post) | Change in AUCIG,0-2h | Baseline | 11.48 mmol/L | Standard Deviation 3.43 |
| Faster Aspart (Post) | Change in AUCIG,0-2h | Change from baseline | 0.75 mmol/L | Standard Deviation 3.74 |
| NovoRapid (Meal) | Change in AUCIG,0-2h | Baseline | 11.76 mmol/L | Standard Deviation 2.8 |
| NovoRapid (Meal) | Change in AUCIG,0-2h | Change from baseline | -0.86 mmol/L | Standard Deviation 3.61 |
Secondary
Change in AUCIG,0-30min
Change in area under the IG curve 0-30 minutes post meal (AUCIG,0-30min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in AUCIG,0-30min | Baseline | 8.28 mmol/L | Standard Deviation 2.75 |
| Faster Aspart (Meal) | Change in AUCIG,0-30min | Change from baseline | -1.15 mmol/L | Standard Deviation 3.62 |
| Faster Aspart (Post) | Change in AUCIG,0-30min | Baseline | 7.80 mmol/L | Standard Deviation 2.13 |
| Faster Aspart (Post) | Change in AUCIG,0-30min | Change from baseline | 0.22 mmol/L | Standard Deviation 2.52 |
| NovoRapid (Meal) | Change in AUCIG,0-30min | Baseline | 8.13 mmol/L | Standard Deviation 1.87 |
| NovoRapid (Meal) | Change in AUCIG,0-30min | Change from baseline | -0.47 mmol/L | Standard Deviation 2.81 |
Secondary
Change in AUCIG,0-4h
Change in area under the IG curve 0-4 hours post meal (AUCIG,0-4h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in AUCIG,0-4h | Baseline | 11.21 mmol/L | Standard Deviation 3.25 |
| Faster Aspart (Meal) | Change in AUCIG,0-4h | Change from baseline | -0.38 mmol/L | Standard Deviation 3.96 |
| Faster Aspart (Post) | Change in AUCIG,0-4h | Baseline | 11.19 mmol/L | Standard Deviation 3.47 |
| Faster Aspart (Post) | Change in AUCIG,0-4h | Change from baseline | 0.62 mmol/L | Standard Deviation 3.97 |
| NovoRapid (Meal) | Change in AUCIG,0-4h | Baseline | 11.46 mmol/L | Standard Deviation 3.21 |
| NovoRapid (Meal) | Change in AUCIG,0-4h | Change from baseline | -1.30 mmol/L | Standard Deviation 4.13 |
Secondary
Change in Biochemistry: Alanine Aminotransferase (ALT)
Change from baseline (week 0) in ALT was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Biochemistry: Alanine Aminotransferase (ALT) | Baseline | 14.4 U/L | Standard Deviation 6.4 |
| Faster Aspart (Meal) | Change in Biochemistry: Alanine Aminotransferase (ALT) | Change from baseline | 0.1 U/L | Standard Deviation 6.9 |
| Faster Aspart (Post) | Change in Biochemistry: Alanine Aminotransferase (ALT) | Baseline | 14.7 U/L | Standard Deviation 7.4 |
| Faster Aspart (Post) | Change in Biochemistry: Alanine Aminotransferase (ALT) | Change from baseline | 1.3 U/L | Standard Deviation 14.9 |
| NovoRapid (Meal) | Change in Biochemistry: Alanine Aminotransferase (ALT) | Baseline | 14.8 U/L | Standard Deviation 5.6 |
| NovoRapid (Meal) | Change in Biochemistry: Alanine Aminotransferase (ALT) | Change from baseline | 0.5 U/L | Standard Deviation 5.9 |
Secondary
Change in Biochemistry: Albumin
Change from baseline (week 0) in albumin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Biochemistry: Albumin | Baseline | 4.47 g/dL | Standard Deviation 0.24 |
| Faster Aspart (Meal) | Change in Biochemistry: Albumin | Change from baseline | 0.01 g/dL | Standard Deviation 0.24 |
| Faster Aspart (Post) | Change in Biochemistry: Albumin | Baseline | 4.51 g/dL | Standard Deviation 0.24 |
| Faster Aspart (Post) | Change in Biochemistry: Albumin | Change from baseline | 0.01 g/dL | Standard Deviation 0.25 |
| NovoRapid (Meal) | Change in Biochemistry: Albumin | Baseline | 4.50 g/dL | Standard Deviation 0.25 |
| NovoRapid (Meal) | Change in Biochemistry: Albumin | Change from baseline | 0.005 g/dL | Standard Deviation 0.24 |
Secondary
Change in Biochemistry: Alkaline Phosphatase (AP)
Change from baseline (week 0) in AP was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Biochemistry: Alkaline Phosphatase (AP) | Baseline | 212.7 U/L | Standard Deviation 135.8 |
| Faster Aspart (Meal) | Change in Biochemistry: Alkaline Phosphatase (AP) | Change from baseline | -3.0 U/L | Standard Deviation 119 |
| Faster Aspart (Post) | Change in Biochemistry: Alkaline Phosphatase (AP) | Baseline | 209.8 U/L | Standard Deviation 94.9 |
| Faster Aspart (Post) | Change in Biochemistry: Alkaline Phosphatase (AP) | Change from baseline | -1.7 U/L | Standard Deviation 50.8 |
| NovoRapid (Meal) | Change in Biochemistry: Alkaline Phosphatase (AP) | Baseline | 226.2 U/L | Standard Deviation 93.6 |
| NovoRapid (Meal) | Change in Biochemistry: Alkaline Phosphatase (AP) | Change from baseline | -2.8 U/L | Standard Deviation 80.4 |
Secondary
Change in Biochemistry: Aspartate Aminotransferase (AST)
Change from baseline (week 0) in AST was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Biochemistry: Aspartate Aminotransferase (AST) | Baseline | 19.9 U/L | Standard Deviation 6.8 |
| Faster Aspart (Meal) | Change in Biochemistry: Aspartate Aminotransferase (AST) | Change from baseline | 0.1 U/L | Standard Deviation 6.2 |
| Faster Aspart (Post) | Change in Biochemistry: Aspartate Aminotransferase (AST) | Baseline | 20.0 U/L | Standard Deviation 5.6 |
| Faster Aspart (Post) | Change in Biochemistry: Aspartate Aminotransferase (AST) | Change from baseline | 1.1 U/L | Standard Deviation 11.7 |
| NovoRapid (Meal) | Change in Biochemistry: Aspartate Aminotransferase (AST) | Baseline | 20.5 U/L | Standard Deviation 5.9 |
| NovoRapid (Meal) | Change in Biochemistry: Aspartate Aminotransferase (AST) | Change from baseline | -0.4 U/L | Standard Deviation 5 |
Secondary
Change in Biochemistry: Creatinine
Change from baseline (week 0) in creatinine was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Biochemistry: Creatinine | Baseline | 51.8 umol/L | Standard Deviation 14.2 |
| Faster Aspart (Meal) | Change in Biochemistry: Creatinine | Change from baseline | 1.1 umol/L | Standard Deviation 7.8 |
| Faster Aspart (Post) | Change in Biochemistry: Creatinine | Baseline | 52.6 umol/L | Standard Deviation 13.3 |
| Faster Aspart (Post) | Change in Biochemistry: Creatinine | Change from baseline | 1.5 umol/L | Standard Deviation 6.9 |
| NovoRapid (Meal) | Change in Biochemistry: Creatinine | Baseline | 52.1 umol/L | Standard Deviation 12.3 |
| NovoRapid (Meal) | Change in Biochemistry: Creatinine | Change from baseline | 1.7 umol/L | Standard Deviation 6.8 |
Secondary
Change in Biochemistry: Potassium
Change from baseline (week 0) in potassium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Biochemistry: Potassium | Baseline | 4.48 mmol/L | Standard Deviation 0.34 |
| Faster Aspart (Meal) | Change in Biochemistry: Potassium | Change from baseline | 0.02 mmol/L | Standard Deviation 0.41 |
| Faster Aspart (Post) | Change in Biochemistry: Potassium | Baseline | 4.52 mmol/L | Standard Deviation 0.34 |
| Faster Aspart (Post) | Change in Biochemistry: Potassium | Change from baseline | -0.06 mmol/L | Standard Deviation 0.34 |
| NovoRapid (Meal) | Change in Biochemistry: Potassium | Baseline | 4.52 mmol/L | Standard Deviation 0.4 |
| NovoRapid (Meal) | Change in Biochemistry: Potassium | Change from baseline | 0.01 mmol/L | Standard Deviation 0.5 |
Secondary
Change in Biochemistry: Sodium
Change from baseline (week 0) in sodium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Biochemistry: Sodium | Baseline | 139.5 mmol/L | Standard Deviation 2.5 |
| Faster Aspart (Meal) | Change in Biochemistry: Sodium | Change from baseline | 0.5 mmol/L | Standard Deviation 2.8 |
| Faster Aspart (Post) | Change in Biochemistry: Sodium | Baseline | 139.6 mmol/L | Standard Deviation 2.4 |
| Faster Aspart (Post) | Change in Biochemistry: Sodium | Change from baseline | 0.3 mmol/L | Standard Deviation 2.7 |
| NovoRapid (Meal) | Change in Biochemistry: Sodium | Baseline | 139.7 mmol/L | Standard Deviation 2.5 |
| NovoRapid (Meal) | Change in Biochemistry: Sodium | Change from baseline | 0.04 mmol/L | Standard Deviation 2.8 |
Secondary
Change in Biochemistry: Total Bilirubin
Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Biochemistry: Total Bilirubin | Baseline | 7.9 umol/L | Standard Deviation 6 |
| Faster Aspart (Meal) | Change in Biochemistry: Total Bilirubin | Change from baseline | 0.2 umol/L | Standard Deviation 4.9 |
| Faster Aspart (Post) | Change in Biochemistry: Total Bilirubin | Baseline | 7.9 umol/L | Standard Deviation 5.3 |
| Faster Aspart (Post) | Change in Biochemistry: Total Bilirubin | Change from baseline | 0.2 umol/L | Standard Deviation 3.4 |
| NovoRapid (Meal) | Change in Biochemistry: Total Bilirubin | Baseline | 8.0 umol/L | Standard Deviation 6.2 |
| NovoRapid (Meal) | Change in Biochemistry: Total Bilirubin | Change from baseline | 0.3 umol/L | Standard Deviation 4.1 |
Secondary
Change in Body Mass Index
Change from baseline (week 0) in body mass index (BMI) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Body Mass Index | Baseline | 19.68 kg/m^2 | Standard Deviation 3.75 |
| Faster Aspart (Meal) | Change in Body Mass Index | Change from baseline | 0.37 kg/m^2 | Standard Deviation 0.92 |
| Faster Aspart (Post) | Change in Body Mass Index | Baseline | 19.67 kg/m^2 | Standard Deviation 4.02 |
| Faster Aspart (Post) | Change in Body Mass Index | Change from baseline | 0.28 kg/m^2 | Standard Deviation 0.92 |
| NovoRapid (Meal) | Change in Body Mass Index | Baseline | 19.64 kg/m^2 | Standard Deviation 3.78 |
| NovoRapid (Meal) | Change in Body Mass Index | Change from baseline | 0.34 kg/m^2 | Standard Deviation 1.1 |
Secondary
Change in Body Weight
Change from baseline (week 0) in body weight was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Body Weight | Baseline | 46.69 kg | Standard Deviation 18.15 |
| Faster Aspart (Meal) | Change in Body Weight | Change from baseline | 2.21 kg | Standard Deviation 2.57 |
| Faster Aspart (Post) | Change in Body Weight | Baseline | 46.48 kg | Standard Deviation 18.98 |
| Faster Aspart (Post) | Change in Body Weight | Change from baseline | 1.90 kg | Standard Deviation 2.32 |
| NovoRapid (Meal) | Change in Body Weight | Baseline | 46.28 kg | Standard Deviation 17.18 |
| NovoRapid (Meal) | Change in Body Weight | Change from baseline | 2.15 kg | Standard Deviation 2.8 |
Secondary
Change in FPG
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in FPG | Baseline | 7.58 mmol/L | Standard Deviation 3.56 |
| Faster Aspart (Meal) | Change in FPG | Change from baseline | 0.41 mmol/L | Standard Deviation 5.04 |
| Faster Aspart (Post) | Change in FPG | Baseline | 8.03 mmol/L | Standard Deviation 3.35 |
| Faster Aspart (Post) | Change in FPG | Change from baseline | -0.08 mmol/L | Standard Deviation 4.49 |
| NovoRapid (Meal) | Change in FPG | Baseline | 7.79 mmol/L | Standard Deviation 3.48 |
| NovoRapid (Meal) | Change in FPG | Change from baseline | -0.13 mmol/L | Standard Deviation 4.16 |
Secondary
Change in Haematology: Erythrocytes
Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Haematology: Erythrocytes | Baseline | 4.81 10^12 cells/L | Standard Deviation 0.39 |
| Faster Aspart (Meal) | Change in Haematology: Erythrocytes | Change from baseline | 0.02 10^12 cells/L | Standard Deviation 0.27 |
| Faster Aspart (Post) | Change in Haematology: Erythrocytes | Baseline | 4.87 10^12 cells/L | Standard Deviation 0.39 |
| Faster Aspart (Post) | Change in Haematology: Erythrocytes | Change from baseline | 0.04 10^12 cells/L | Standard Deviation 0.31 |
| NovoRapid (Meal) | Change in Haematology: Erythrocytes | Baseline | 4.88 10^12 cells/L | Standard Deviation 0.4 |
| NovoRapid (Meal) | Change in Haematology: Erythrocytes | Change from baseline | 0.02 10^12 cells/L | Standard Deviation 0.26 |
Secondary
Change in Haematology: Haematocrit
Change from baseline (week 0) in haematocrit was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Haematology: Haematocrit | Baseline | 40.87 % of red blood cells | Standard Deviation 3.39 |
| Faster Aspart (Meal) | Change in Haematology: Haematocrit | Change from baseline | 0.45 % of red blood cells | Standard Deviation 2.86 |
| Faster Aspart (Post) | Change in Haematology: Haematocrit | Baseline | 41.51 % of red blood cells | Standard Deviation 3.5 |
| Faster Aspart (Post) | Change in Haematology: Haematocrit | Change from baseline | 0.40 % of red blood cells | Standard Deviation 3.09 |
| NovoRapid (Meal) | Change in Haematology: Haematocrit | Baseline | 41.34 % of red blood cells | Standard Deviation 3.75 |
| NovoRapid (Meal) | Change in Haematology: Haematocrit | Change from baseline | 0.32 % of red blood cells | Standard Deviation 2.75 |
Secondary
Change in Haematology: Haemoglobin
Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Haematology: Haemoglobin | Baseline | 8.33 mmol/L | Standard Deviation 0.72 |
| Faster Aspart (Meal) | Change in Haematology: Haemoglobin | Change from baseline | 0.08 mmol/L | Standard Deviation 0.51 |
| Faster Aspart (Post) | Change in Haematology: Haemoglobin | Baseline | 8.47 mmol/L | Standard Deviation 0.74 |
| Faster Aspart (Post) | Change in Haematology: Haemoglobin | Change from baseline | 0.09 mmol/L | Standard Deviation 0.62 |
| NovoRapid (Meal) | Change in Haematology: Haemoglobin | Baseline | 8.41 mmol/L | Standard Deviation 0.77 |
| NovoRapid (Meal) | Change in Haematology: Haemoglobin | Change from baseline | 0.09 mmol/L | Standard Deviation 0.52 |
Secondary
Change in Haematology: Leukocytes
Change from baseline (week 0) in leukocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Haematology: Leukocytes | Baseline | 6.10 10^9 cells/L | Standard Deviation 1.65 |
| Faster Aspart (Meal) | Change in Haematology: Leukocytes | Change from baseline | 0.08 10^9 cells/L | Standard Deviation 1.66 |
| Faster Aspart (Post) | Change in Haematology: Leukocytes | Baseline | 6.10 10^9 cells/L | Standard Deviation 1.63 |
| Faster Aspart (Post) | Change in Haematology: Leukocytes | Change from baseline | 0.14 10^9 cells/L | Standard Deviation 1.74 |
| NovoRapid (Meal) | Change in Haematology: Leukocytes | Baseline | 6.11 10^9 cells/L | Standard Deviation 1.81 |
| NovoRapid (Meal) | Change in Haematology: Leukocytes | Change from baseline | 0.10 10^9 cells/L | Standard Deviation 1.67 |
Secondary
Change in Haematology: Thrombocytes
Change from baseline (week 0) in thrombocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Haematology: Thrombocytes | Baseline | 268.1 10^9 cells/L | Standard Deviation 64.5 |
| Faster Aspart (Meal) | Change in Haematology: Thrombocytes | Change from baseline | 1.2 10^9 cells/L | Standard Deviation 47.3 |
| Faster Aspart (Post) | Change in Haematology: Thrombocytes | Baseline | 270.0 10^9 cells/L | Standard Deviation 60.2 |
| Faster Aspart (Post) | Change in Haematology: Thrombocytes | Change from baseline | 1.6 10^9 cells/L | Standard Deviation 45.4 |
| NovoRapid (Meal) | Change in Haematology: Thrombocytes | Baseline | 262.5 10^9 cells/L | Standard Deviation 57.9 |
| NovoRapid (Meal) | Change in Haematology: Thrombocytes | Change from baseline | 6.0 10^9 cells/L | Standard Deviation 44.9 |
Secondary
Change in Height
Change from baseline (week 0) in height was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Height | Baseline | 1.50 Meter | Standard Deviation 0.21 |
| Faster Aspart (Meal) | Change in Height | Change from baseline | 0.02 Meter | Standard Deviation 0.02 |
| Faster Aspart (Post) | Change in Height | Baseline | 1.50 Meter | Standard Deviation 0.21 |
| Faster Aspart (Post) | Change in Height | Change from baseline | 0.02 Meter | Standard Deviation 0.02 |
| NovoRapid (Meal) | Change in Height | Baseline | 1.50 Meter | Standard Deviation 0.19 |
| NovoRapid (Meal) | Change in Height | Change from baseline | 0.02 Meter | Standard Deviation 0.02 |
Secondary
Change in IG Peak After Start of Meal
Change in IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in IG Peak After Start of Meal | Baseline | 14.87 mmol/L | Standard Deviation 3.55 |
| Faster Aspart (Meal) | Change in IG Peak After Start of Meal | Change from baseline | -0.55 mmol/L | Standard Deviation 3.77 |
| Faster Aspart (Post) | Change in IG Peak After Start of Meal | Baseline | 15.15 mmol/L | Standard Deviation 4.52 |
| Faster Aspart (Post) | Change in IG Peak After Start of Meal | Change from baseline | 1.11 mmol/L | Standard Deviation 4.88 |
| NovoRapid (Meal) | Change in IG Peak After Start of Meal | Baseline | 15.11 mmol/L | Standard Deviation 3.62 |
| NovoRapid (Meal) | Change in IG Peak After Start of Meal | Change from baseline | -1.36 mmol/L | Standard Deviation 4.36 |
Secondary
Change in Lipid Profile: High Density Lipoproteins (HDL)
Change from baseline (week 0) in HDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change in Lipid Profile: High Density Lipoproteins (HDL) | 1.004 Ratio | Geometric Coefficient of Variation 17.865 |
| Faster Aspart (Post) | Change in Lipid Profile: High Density Lipoproteins (HDL) | 1.030 Ratio | Geometric Coefficient of Variation 20.18 |
| NovoRapid (Meal) | Change in Lipid Profile: High Density Lipoproteins (HDL) | 1.023 Ratio | Geometric Coefficient of Variation 17.852 |
Secondary
Change in Lipid Profile: Low Density Lipoproteins (LDL)
Change from baseline (week 0) in LDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change in Lipid Profile: Low Density Lipoproteins (LDL) | 1.014 Ratio | Geometric Coefficient of Variation 19.533 |
| Faster Aspart (Post) | Change in Lipid Profile: Low Density Lipoproteins (LDL) | 1.040 Ratio | Geometric Coefficient of Variation 19.685 |
| NovoRapid (Meal) | Change in Lipid Profile: Low Density Lipoproteins (LDL) | 1.041 Ratio | Geometric Coefficient of Variation 19.864 |
Secondary
Change in Lipid Profile: Total Cholesterol
Change from baseline (week 0) in total cholesterol after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change in Lipid Profile: Total Cholesterol | 0.989 Ratio | Geometric Coefficient of Variation 13.869 |
| Faster Aspart (Post) | Change in Lipid Profile: Total Cholesterol | 1.023 Ratio | Geometric Coefficient of Variation 13.742 |
| NovoRapid (Meal) | Change in Lipid Profile: Total Cholesterol | 1.016 Ratio | Geometric Coefficient of Variation 13.187 |
Secondary
Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal)
Change from baseline (week 0) in mean IG increment (0-1 hours and 0-2 hours after start of the meal) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-1 hour: Baseline | 0.56 mmol/L | Standard Deviation 0.58 |
| Faster Aspart (Meal) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-1 hour: Change from baseline | -0.19 mmol/L | Standard Deviation 0.55 |
| Faster Aspart (Meal) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-2 hour: Baseline | 0.76 mmol/L | Standard Deviation 0.75 |
| Faster Aspart (Meal) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-2 hour: Change from baseline | -0.35 mmol/L | Standard Deviation 0.87 |
| Faster Aspart (Post) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-2 hour: Change from baseline | 0.55 mmol/L | Standard Deviation 1.14 |
| Faster Aspart (Post) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-1 hour: Baseline | 0.73 mmol/L | Standard Deviation 0.54 |
| Faster Aspart (Post) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-2 hour: Baseline | 1.10 mmol/L | Standard Deviation 1.03 |
| Faster Aspart (Post) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-1 hour: Change from baseline | 0.26 mmol/L | Standard Deviation 0.83 |
| NovoRapid (Meal) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-2 hour: Change from baseline | 0.09 mmol/L | Standard Deviation 0.59 |
| NovoRapid (Meal) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-1 hour: Change from baseline | 0.07 mmol/L | Standard Deviation 0.5 |
| NovoRapid (Meal) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-2 hour: Baseline | 0.86 mmol/L | Standard Deviation 0.69 |
| NovoRapid (Meal) | Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal) | 0-1 hour: Baseline | 0.61 mmol/L | Standard Deviation 0.49 |
Secondary
Change in Mean IG Peak After Start of Meal
Change from baseline (week 0) in mean IG peak after start of meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Mean IG Peak After Start of Meal | Baseline | 12.90 mmol/L | Standard Deviation 1.88 |
| Faster Aspart (Meal) | Change in Mean IG Peak After Start of Meal | Change from baseline | -0.28 mmol/L | Standard Deviation 1.91 |
| Faster Aspart (Post) | Change in Mean IG Peak After Start of Meal | Baseline | 12.92 mmol/L | Standard Deviation 1.97 |
| Faster Aspart (Post) | Change in Mean IG Peak After Start of Meal | Change from baseline | 0.80 mmol/L | Standard Deviation 1.84 |
| NovoRapid (Meal) | Change in Mean IG Peak After Start of Meal | Baseline | 12.90 mmol/L | Standard Deviation 2.25 |
| NovoRapid (Meal) | Change in Mean IG Peak After Start of Meal | Change from baseline | 0.38 mmol/L | Standard Deviation 2 |
Secondary
Change in Mean Time to the IG Peak After Meal
Change from baseline (week 0) in mean time to the IG peak after meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of subjects wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Mean Time to the IG Peak After Meal | Baseline | 103.16 Minutes | Standard Deviation 16.87 |
| Faster Aspart (Meal) | Change in Mean Time to the IG Peak After Meal | Change from baseline | 4.70 Minutes | Standard Deviation 25.85 |
| Faster Aspart (Post) | Change in Mean Time to the IG Peak After Meal | Baseline | 106.21 Minutes | Standard Deviation 20.68 |
| Faster Aspart (Post) | Change in Mean Time to the IG Peak After Meal | Change from baseline | -8.56 Minutes | Standard Deviation 22.62 |
| NovoRapid (Meal) | Change in Mean Time to the IG Peak After Meal | Baseline | 102.20 Minutes | Standard Deviation 17.09 |
| NovoRapid (Meal) | Change in Mean Time to the IG Peak After Meal | Change from baseline | 2.29 Minutes | Standard Deviation 19.8 |
Secondary
Change in Physical Examination
The following physical examinations were done: 1) Cardiovascular system. 2) Central and peripheral nervous system. 3) Gastrointestinal system including the mouth. 4) General appearance. 5) Head, ears, eyes, nose, throat and neck. 6) Musculoskeletal system. 7) Respiratory system. 8) Skin. Presented results are number of participants with the following outcomes: normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS). Presented results are baseline (week 0) and last on-treatment values. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Change in Physical Examination | 7) Baseline: Abnormal, NCS | 1 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 4) Baseline: Abnormal, CS | 1 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 8) Last on-treatment: Abnormal, CS | 9 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 7) Baseline: Normal | 259 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 4) Last on-treatment: Normal | 257 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 2) Last on-treatment: Abnormal, NCS | 2 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 6) Last on-treatment: Abnormal, CS | 2 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 4) Last on-treatment: Abnormal, NCS | 0 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 1) Last on-treatment: Abnormal, NCS | 0 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 6) Last on-treatment: Abnormal, NCS | 1 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 4) Last on-treatment: Abnormal, CS | 0 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 8) Last on-treatment: Abnormal, NCS | 19 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 6) Last on-treatment: Normal | 254 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 5) Baseline: Normal | 251 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 2) Last on-treatment: Abnormal, CS | 0 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 6) Baseline: Abnormal, CS | 0 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 5) Baseline: Abnormal, NCS | 9 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 1) Baseline: Abnormal, CS | 0 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 6) Baseline: Abnormal, NCS | 2 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 8) Last on-treatment: Normal | 229 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 5) Baseline: Abnormal, CS | 1 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 3) Baseline: Normal | 258 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 6) Baseline: Normal | 259 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 5) Last on-treatment: Normal | 247 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 5) Last on-treatment: Abnormal, CS | 3 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 5) Last on-treatment: Abnormal, NCS | 7 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 2) Baseline: Abnormal, NCS | 3 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 8) Baseline: Abnormal, CS | 4 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 3) Baseline: Abnormal, NCS | 3 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 1) Last on-treatment: Abnormal, CS | 0 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 8) Baseline: Abnormal, NCS | 18 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 3) Baseline: Abnormal, CS | 0 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 1) Baseline: Abnormal, NCS | 1 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 8) Baseline: Normal | 239 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 3) Last on-treatment: Normal | 253 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 2) Baseline: Abnormal, CS | 1 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 7) Last on-treatment: Abnormal, CS | 0 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 3) Last on-treatment: Abnormal, NCS | 4 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 1) Last on-treatment: Normal | 257 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 7) Last on-treatment: Abnormal, NCS | 0 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 3) Last on-treatment: Abnormal, CS | 0 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 1) Baseline: Normal | 260 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 7) Last on-treatment: Normal | 257 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 4) Baseline: Normal | 258 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 2) Last on-treatment: Normal | 255 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 7) Baseline: Abnormal, CS | 1 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 4) Baseline: Abnormal, NCS | 2 Participants |
| Faster Aspart (Meal) | Change in Physical Examination | 2) Baseline: Normal | 257 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 5) Last on-treatment: Normal | 244 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 1) Last on-treatment: Abnormal, NCS | 5 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 1) Last on-treatment: Abnormal, CS | 0 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 6) Last on-treatment: Abnormal, CS | 2 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 2) Baseline: Normal | 253 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 2) Baseline: Abnormal, NCS | 4 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 2) Baseline: Abnormal, CS | 1 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 2) Last on-treatment: Normal | 253 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 2) Last on-treatment: Abnormal, NCS | 4 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 2) Last on-treatment: Abnormal, CS | 1 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 3) Baseline: Normal | 257 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 3) Baseline: Abnormal, NCS | 1 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 3) Baseline: Abnormal, CS | 0 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 3) Last on-treatment: Normal | 257 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 3) Last on-treatment: Abnormal, NCS | 1 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 3) Last on-treatment: Abnormal, CS | 0 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 4) Baseline: Normal | 253 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 4) Baseline: Abnormal, NCS | 3 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 4) Baseline: Abnormal, CS | 2 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 4) Last on-treatment: Normal | 253 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 4) Last on-treatment: Abnormal, NCS | 4 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 4) Last on-treatment: Abnormal, CS | 1 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 5) Baseline: Normal | 238 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 5) Baseline: Abnormal, NCS | 13 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 6) Baseline: Normal | 252 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 5) Baseline: Abnormal, CS | 7 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 5) Last on-treatment: Abnormal, NCS | 11 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 5) Last on-treatment: Abnormal, CS | 3 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 6) Baseline: Abnormal, NCS | 4 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 6) Baseline: Abnormal, CS | 2 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 6) Last on-treatment: Normal | 253 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 6) Last on-treatment: Abnormal, NCS | 3 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 7) Baseline: Normal | 256 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 7) Baseline: Abnormal, NCS | 2 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 7) Baseline: Abnormal, CS | 0 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 7) Last on-treatment: Normal | 258 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 7) Last on-treatment: Abnormal, NCS | 0 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 7) Last on-treatment: Abnormal, CS | 0 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 8) Baseline: Normal | 237 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 8) Baseline: Abnormal, NCS | 21 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 8) Baseline: Abnormal, CS | 0 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 8) Last on-treatment: Normal | 233 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 8) Last on-treatment: Abnormal, NCS | 22 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 8) Last on-treatment: Abnormal, CS | 3 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 1) Baseline: Normal | 254 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 1) Baseline: Abnormal, NCS | 4 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 1) Baseline: Abnormal, CS | 0 Participants |
| Faster Aspart (Post) | Change in Physical Examination | 1) Last on-treatment: Normal | 253 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 2) Last on-treatment: Normal | 257 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 7) Baseline: Normal | 256 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 4) Baseline: Abnormal, NCS | 4 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 1) Baseline: Abnormal, CS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 7) Baseline: Abnormal, NCS | 1 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 4) Baseline: Normal | 254 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 8) Last on-treatment: Abnormal, CS | 5 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 7) Baseline: Abnormal, CS | 1 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 3) Last on-treatment: Abnormal, CS | 1 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 2) Baseline: Abnormal, CS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 7) Last on-treatment: Normal | 257 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 3) Last on-treatment: Abnormal, NCS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 1) Last on-treatment: Abnormal, CS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 7) Last on-treatment: Abnormal, NCS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 3) Last on-treatment: Normal | 256 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 1) Baseline: Normal | 258 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 7) Last on-treatment: Abnormal, CS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 3) Baseline: Abnormal, CS | 1 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 2) Baseline: Abnormal, NCS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 8) Baseline: Normal | 238 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 3) Baseline: Abnormal, NCS | 3 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 1) Last on-treatment: Abnormal, NCS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 8) Baseline: Abnormal, NCS | 16 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 3) Baseline: Normal | 254 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 1) Baseline: Abnormal, NCS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 8) Baseline: Abnormal, CS | 4 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 5) Last on-treatment: Normal | 242 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 2) Last on-treatment: Abnormal, CS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 5) Last on-treatment: Abnormal, NCS | 14 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 6) Baseline: Normal | 254 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 2) Baseline: Normal | 258 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 5) Last on-treatment: Abnormal, CS | 1 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 5) Baseline: Abnormal, CS | 2 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 5) Baseline: Abnormal, NCS | 11 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 8) Last on-treatment: Normal | 235 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 6) Baseline: Abnormal, NCS | 3 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 5) Baseline: Normal | 245 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 2) Last on-treatment: Abnormal, NCS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 6) Baseline: Abnormal, CS | 1 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 4) Last on-treatment: Abnormal, CS | 0 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 1) Last on-treatment: Normal | 257 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 6) Last on-treatment: Normal | 253 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 4) Last on-treatment: Abnormal, NCS | 3 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 8) Last on-treatment: Abnormal, NCS | 17 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 6) Last on-treatment: Abnormal, NCS | 3 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 4) Last on-treatment: Normal | 254 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 6) Last on-treatment: Abnormal, CS | 1 Participants |
| NovoRapid (Meal) | Change in Physical Examination | 4) Baseline: Abnormal, CS | 0 Participants |
Secondary
Change in SD Score of Body Mass Index
Change from baseline (week 0) in SD score of BMI was evaluated after 26 weeks of randomisation. SD scores for BMI were determined in a similar way as SD scores for weight by use of a suitable reference population based on age and sex. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in SD Score of Body Mass Index | Baseline | 0.296 Standard deviation score | Standard Deviation 0.895 |
| Faster Aspart (Meal) | Change in SD Score of Body Mass Index | Change from baseline | 0.016 Standard deviation score | Standard Deviation 0.308 |
| Faster Aspart (Post) | Change in SD Score of Body Mass Index | Baseline | 0.298 Standard deviation score | Standard Deviation 0.936 |
| Faster Aspart (Post) | Change in SD Score of Body Mass Index | Change from baseline | 0.004 Standard deviation score | Standard Deviation 0.37 |
| NovoRapid (Meal) | Change in SD Score of Body Mass Index | Baseline | 0.317 Standard deviation score | Standard Deviation 0.898 |
| NovoRapid (Meal) | Change in SD Score of Body Mass Index | Change from baseline | 0.007 Standard deviation score | Standard Deviation 0.338 |
Secondary
Change in SD Score of Body Weight
Change from baseline (week 0) in standard deviation (SD) score of body weight was evaluated after 26 weeks of randomisation. SD-scores are defined to be able to normalise the body weight in the various age groups. To estimate the growth of children, standardised weight is calculated for each year of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2. The SD scores are derived from the age and sex of the subjects and the body weight together with growth curves defined for a reference population. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in SD Score of Body Weight | Baseline | 0.349 Standard deviation score | Standard Deviation 0.945 |
| Faster Aspart (Meal) | Change in SD Score of Body Weight | Change from baseline | 0.034 Standard deviation score | Standard Deviation 0.231 |
| Faster Aspart (Post) | Change in SD Score of Body Weight | Baseline | 0.351 Standard deviation score | Standard Deviation 0.936 |
| Faster Aspart (Post) | Change in SD Score of Body Weight | Change from baseline | 0.008 Standard deviation score | Standard Deviation 0.223 |
| NovoRapid (Meal) | Change in SD Score of Body Weight | Baseline | 0.361 Standard deviation score | Standard Deviation 0.875 |
| NovoRapid (Meal) | Change in SD Score of Body Weight | Change from baseline | 0.030 Standard deviation score | Standard Deviation 0.25 |
Secondary
Change in Time to the IG Peak After Start of Meal
Change in time to the IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Time to the IG Peak After Start of Meal | Baseline | 102.85 Minute | Standard Deviation 48.93 |
| Faster Aspart (Meal) | Change in Time to the IG Peak After Start of Meal | Change from baseline | 5.29 Minute | Standard Deviation 55.42 |
| Faster Aspart (Post) | Change in Time to the IG Peak After Start of Meal | Baseline | 94.26 Minute | Standard Deviation 38.22 |
| Faster Aspart (Post) | Change in Time to the IG Peak After Start of Meal | Change from baseline | -0.04 Minute | Standard Deviation 42.05 |
| NovoRapid (Meal) | Change in Time to the IG Peak After Start of Meal | Baseline | 93.80 Minute | Standard Deviation 39.19 |
| NovoRapid (Meal) | Change in Time to the IG Peak After Start of Meal | Change from baseline | -8.76 Minute | Standard Deviation 52.17 |
Secondary
Change in Vital Sign: Blood Pressure
Change from baseline (week 0) in blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Vital Sign: Blood Pressure | SBP: Baseline | 106.4 mmHg | Standard Deviation 11.8 |
| Faster Aspart (Meal) | Change in Vital Sign: Blood Pressure | SBP: Change from baseline | 0.8 mmHg | Standard Deviation 11 |
| Faster Aspart (Meal) | Change in Vital Sign: Blood Pressure | DBP: Baseline | 65.4 mmHg | Standard Deviation 8.3 |
| Faster Aspart (Meal) | Change in Vital Sign: Blood Pressure | DBP: Change from baseline | 1.2 mmHg | Standard Deviation 9.1 |
| Faster Aspart (Post) | Change in Vital Sign: Blood Pressure | DBP: Change from baseline | 1.4 mmHg | Standard Deviation 9.3 |
| Faster Aspart (Post) | Change in Vital Sign: Blood Pressure | SBP: Baseline | 107.0 mmHg | Standard Deviation 12.6 |
| Faster Aspart (Post) | Change in Vital Sign: Blood Pressure | DBP: Baseline | 65.7 mmHg | Standard Deviation 9.4 |
| Faster Aspart (Post) | Change in Vital Sign: Blood Pressure | SBP: Change from baseline | 1.5 mmHg | Standard Deviation 10.4 |
| NovoRapid (Meal) | Change in Vital Sign: Blood Pressure | DBP: Change from baseline | 1.4 mmHg | Standard Deviation 8.3 |
| NovoRapid (Meal) | Change in Vital Sign: Blood Pressure | SBP: Change from baseline | 1.1 mmHg | Standard Deviation 10.1 |
| NovoRapid (Meal) | Change in Vital Sign: Blood Pressure | DBP: Baseline | 65.4 mmHg | Standard Deviation 7.9 |
| NovoRapid (Meal) | Change in Vital Sign: Blood Pressure | SBP: Baseline | 106.8 mmHg | Standard Deviation 11.4 |
Secondary
Change in Vital Sign: Pulse
Change from baseline (week 0) in pulse was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.
Time frame: Week 0, Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change in Vital Sign: Pulse | Baseline | 80.6 Beats/minute | Standard Deviation 11.8 |
| Faster Aspart (Meal) | Change in Vital Sign: Pulse | Change from baseline | -0.6 Beats/minute | Standard Deviation 10.3 |
| Faster Aspart (Post) | Change in Vital Sign: Pulse | Baseline | 80.5 Beats/minute | Standard Deviation 11.8 |
| Faster Aspart (Post) | Change in Vital Sign: Pulse | Change from baseline | 0.3 Beats/minute | Standard Deviation 10.8 |
| NovoRapid (Meal) | Change in Vital Sign: Pulse | Baseline | 79.4 Beats/minute | Standard Deviation 11.8 |
| NovoRapid (Meal) | Change in Vital Sign: Pulse | Change from baseline | 0.7 Beats/minute | Standard Deviation 11 |
Secondary
Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL])
Change from baseline (week 0) in the time spent in low IG (\<=3.9 mmol/L \[70 mg/dL\]) based on continuous glucose monitoring (CGM) was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time frame: Week 0, Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL]) | Baseline | 107.94 Minutes/day | Standard Deviation 77.34 |
| Faster Aspart (Meal) | Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL]) | Change from baseline | -24.11 Minutes/day | Standard Deviation 71.74 |
| Faster Aspart (Post) | Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL]) | Baseline | 100.70 Minutes/day | Standard Deviation 77.28 |
| Faster Aspart (Post) | Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL]) | Change from baseline | -13.06 Minutes/day | Standard Deviation 82.55 |
| NovoRapid (Meal) | Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL]) | Baseline | 81.52 Minutes/day | Standard Deviation 71.9 |
| NovoRapid (Meal) | Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL]) | Change from baseline | 6.92 Minutes/day | Standard Deviation 74.64 |
Secondary
Fluctuation in the 8-point SMPG Profile
Fluctuation in the 8-point SMPG profile was evaluated after 26 weeks of randomisation. Fluctuation in 8-point SMPG profile was the average absolute difference from the mean of the SMPG profile. The results are based on the last in-trial value.
Time frame: Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Fluctuation in the 8-point SMPG Profile | 1.88 mmol/L | Geometric Coefficient of Variation 44.49 |
| Faster Aspart (Post) | Fluctuation in the 8-point SMPG Profile | 1.94 mmol/L | Geometric Coefficient of Variation 42.51 |
| NovoRapid (Meal) | Fluctuation in the 8-point SMPG Profile | 1.83 mmol/L | Geometric Coefficient of Variation 45.98 |
Secondary
Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)
Incidence of episodes (number of episodes per 24 hours) with IG \<=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG \>10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was calculated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time frame: Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG >10 mmol/L | 11.52 Episodes per 24 hours |
| Faster Aspart (Meal) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG <=3.9 mmol/L | 2.29 Episodes per 24 hours |
| Faster Aspart (Meal) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG <=2.5 mmol/L | 0.55 Episodes per 24 hours |
| Faster Aspart (Meal) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG <=3.0 mmol/L | 1.01 Episodes per 24 hours |
| Faster Aspart (Meal) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG >12 mmol/L | 7.64 Episodes per 24 hours |
| Faster Aspart (Post) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG <=3.9 mmol/L | 2.30 Episodes per 24 hours |
| Faster Aspart (Post) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG <=2.5 mmol/L | 0.68 Episodes per 24 hours |
| Faster Aspart (Post) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG <=3.0 mmol/L | 1.10 Episodes per 24 hours |
| Faster Aspart (Post) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG >10 mmol/L | 11.61 Episodes per 24 hours |
| Faster Aspart (Post) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG >12 mmol/L | 7.77 Episodes per 24 hours |
| NovoRapid (Meal) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG >12 mmol/L | 8.05 Episodes per 24 hours |
| NovoRapid (Meal) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG >10 mmol/L | 11.65 Episodes per 24 hours |
| NovoRapid (Meal) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG <=2.5 mmol/L | 0.57 Episodes per 24 hours |
| NovoRapid (Meal) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG <=3.9 mmol/L | 2.24 Episodes per 24 hours |
| NovoRapid (Meal) | Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Episodes with IG <=3.0 mmol/L | 1.03 Episodes per 24 hours |
Secondary
Insulin Dose (Units/Day): Individual Meal Insulin Dose
Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.
Time frame: Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Lunch | 8.1 Units (U) | Standard Deviation 5.1 |
| Faster Aspart (Meal) | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Breakfast | 7.3 Units (U) | Standard Deviation 5.1 |
| Faster Aspart (Meal) | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Main evening meal | 8.1 Units (U) | Standard Deviation 6 |
| Faster Aspart (Post) | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Lunch | 8.4 Units (U) | Standard Deviation 6.2 |
| Faster Aspart (Post) | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Breakfast | 7.1 Units (U) | Standard Deviation 4.9 |
| Faster Aspart (Post) | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Main evening meal | 8.0 Units (U) | Standard Deviation 5.4 |
| NovoRapid (Meal) | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Breakfast | 6.8 Units (U) | Standard Deviation 4.4 |
| NovoRapid (Meal) | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Main evening meal | 7.7 Units (U) | Standard Deviation 5.1 |
| NovoRapid (Meal) | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Lunch | 7.9 Units (U) | Standard Deviation 5.2 |
Secondary
Insulin Dose (Units/Day): Total Basal
Total basal insulin dose (Units/day) was evaluated after 26 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 NovoRapid®/NovoLog® / faster aspart and no later than 7 days after the day of last dose of NovoRapid®/NovoLog® / faster aspart. The on-treatment observation period includes data collected up to and including 7 days after treatment discontinuation. Number of participants analysed = number of participants contributed to the analysis. Analysis population description: Safety analysis set (SAS) included all participants receiving at least one dose of the investigational product (faster aspart) or its comparator (NovoRapid®/NovoLog®).
Time frame: Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Insulin Dose (Units/Day): Total Basal | 21.6 Units (U) | Standard Deviation 12.9 |
| Faster Aspart (Post) | Insulin Dose (Units/Day): Total Basal | 21.5 Units (U) | Standard Deviation 14.5 |
| NovoRapid (Meal) | Insulin Dose (Units/Day): Total Basal | 20.7 Units (U) | Standard Deviation 12.8 |
Secondary
Insulin Dose (Units/Day): Total Bolus
Total bolus insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Insulin Dose (Units/Day): Total Bolus | 23.3 Units (U) | Standard Deviation 14.5 |
| Faster Aspart (Post) | Insulin Dose (Units/Day): Total Bolus | 23.5 Units (U) | Standard Deviation 15.1 |
| NovoRapid (Meal) | Insulin Dose (Units/Day): Total Bolus | 22.5 Units (U) | Standard Deviation 13 |
Secondary
Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose
Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Lunch | 0.170 Units (U)/kg | Standard Deviation 0.103 |
| Faster Aspart (Meal) | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Breakfast | 0.151 Units (U)/kg | Standard Deviation 0.091 |
| Faster Aspart (Meal) | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Main evening meal | 0.164 Units (U)/kg | Standard Deviation 0.099 |
| Faster Aspart (Post) | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Lunch | 0.174 Units (U)/kg | Standard Deviation 0.104 |
| Faster Aspart (Post) | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Breakfast | 0.150 Units (U)/kg | Standard Deviation 0.079 |
| Faster Aspart (Post) | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Main evening meal | 0.165 Units (U)/kg | Standard Deviation 0.092 |
| NovoRapid (Meal) | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Breakfast | 0.144 Units (U)/kg | Standard Deviation 0.081 |
| NovoRapid (Meal) | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Main evening meal | 0.158 Units (U)/kg | Standard Deviation 0.086 |
| NovoRapid (Meal) | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Lunch | 0.166 Units (U)/kg | Standard Deviation 0.095 |
Secondary
Insulin Dose (Units/kg/Day): Total Basal
Total basal insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Insulin Dose (Units/kg/Day): Total Basal | 0.433 Units (U)/kg | Standard Deviation 0.228 |
| Faster Aspart (Post) | Insulin Dose (Units/kg/Day): Total Basal | 0.425 Units (U)/kg | Standard Deviation 0.196 |
| NovoRapid (Meal) | Insulin Dose (Units/kg/Day): Total Basal | 0.409 Units (U)/kg | Standard Deviation 0.176 |
Secondary
Insulin Dose (Units/kg/Day): Total Bolus
Total bolus insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.
Time frame: Week 26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Insulin Dose (Units/kg/Day): Total Bolus | 0.483 Units (U)/kg | Standard Deviation 0.256 |
| Faster Aspart (Post) | Insulin Dose (Units/kg/Day): Total Bolus | 0.491 Units (U)/kg | Standard Deviation 0.241 |
| NovoRapid (Meal) | Insulin Dose (Units/kg/Day): Total Bolus | 0.468 Units (U)/kg | Standard Deviation 0.224 |
Secondary
Number of Treatment Emergent Adverse Events (AEs)
Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP (faster aspart or NovoRapid®/NovoLog®) and excluding the events occurring in the run-in period. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Adverse Events (AEs) | 576 Events |
| Faster Aspart (Post) | Number of Treatment Emergent Adverse Events (AEs) | 678 Events |
| NovoRapid (Meal) | Number of Treatment Emergent Adverse Events (AEs) | 593 Events |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Severe | 3 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Documented symptomatic | 4895 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Asymptomatic | 3584 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Probable symptomatic | 10 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Pseudo-hypoglycaemia | 32 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Unclassifiable | 5 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Unclassifiable | 2 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Severe | 5 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Probable symptomatic | 10 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Pseudo-hypoglycaemia | 31 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Documented symptomatic | 5077 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Asymptomatic | 3163 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Documented symptomatic | 4779 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Asymptomatic | 3101 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Unclassifiable | 1 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Probable symptomatic | 22 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Severe | 3 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime | Pseudo-hypoglycaemia | 42 Episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Unclassifiable | 0 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Asymptomatic | 671 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Pseudo-hypoglycaemia | 3 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe | 0 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Probable symptomatic | 2 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Documented symptomatic | 496 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Probable symptomatic | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Pseudo-hypoglycaemia | 6 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Documented symptomatic | 635 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Unclassifiable | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe | 3 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Asymptomatic | 618 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Asymptomatic | 555 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe | 1 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Documented symptomatic | 391 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Unclassifiable | 0 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Probable symptomatic | 2 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Pseudo-hypoglycaemia | 5 Episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total
Treatment emergent: if the onset of the episode occurred on or after the first day of treatment with investigational medicinal product (IMP) after randomisation, and no later than 1 day after the last day on IMP. Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic: episode during which typical symptoms of hypoglycaemia are accompanied by a PG level ≤3.9 mmol/L. 3) Asymptomatic: episode not accompanied by typical symptoms of hypoglycaemia, but with a PG level ≤3.9 mmol/L. 4) Probable symptomatic: an episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG level ≤3.9 mmol/L. 5) Pseudo-hypoglycaemia: episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a PG level \>3.9mmol/L, but approaching that level. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Severe | 3 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Documented symptomatic | 5391 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Asymptomatic | 4255 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Probable symptomatic | 12 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Pseudo-hypoglycaemia | 35 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Unclassifiable | 5 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Unclassifiable | 2 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Severe | 8 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Probable symptomatic | 10 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Pseudo-hypoglycaemia | 37 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Documented symptomatic | 5712 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Asymptomatic | 3781 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Documented symptomatic | 5170 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Asymptomatic | 3656 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Unclassifiable | 1 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Probable symptomatic | 24 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Severe | 4 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total | Pseudo-hypoglycaemia | 47 Episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Severe or BG confirmed | 3187 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Severe or BG confirmed symptomatic | 2062 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Severe | 3 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | BG confirmed | 3184 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Unclassifiable | 5342 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Severe or BG confirmed symptomatic | 2167 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Severe | 5 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | BG confirmed | 3112 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Severe or BG confirmed | 3117 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Unclassifiable | 5171 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Unclassifiable | 4985 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Severe or BG confirmed | 2963 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Severe | 3 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | Severe or BG confirmed symptomatic | 2035 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime | BG confirmed | 2960 Episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe or BG confirmed | 396 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe or BG confirmed symptomatic | 180 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe | 0 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | BG confirmed | 396 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Unclassifiable | 776 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe or BG confirmed symptomatic | 260 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe | 3 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | BG confirmed | 474 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe or BG confirmed | 477 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Unclassifiable | 785 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Unclassifiable | 641 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe or BG confirmed | 313 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe | 1 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | Severe or BG confirmed symptomatic | 159 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included) | BG confirmed | 312 Episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) Symptomatic blood glucose (BG) confirmed: episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3) Asymptomatic BG confirmed: episode that is BG confirmed by PG value \<3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG confirmed symptomatic: an episode that is severe according to the ISPAD classification or BG confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG confirmed: an episode that is BG confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG confirmed: an episode that is severe according to the ISPAD Classification or BG confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Severe or BG confirmed | 3583 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Severe or BG confirmed symptomatic | 2242 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Severe | 3 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | BG confirmed | 3580 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Unclassifiable | 6118 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Severe or BG confirmed symptomatic | 2427 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Severe | 8 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | BG confirmed | 3586 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Severe or BG confirmed | 3594 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Unclassifiable | 5956 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Unclassifiable | 5626 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Severe or BG confirmed | 3276 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Severe | 4 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | Severe or BG confirmed symptomatic | 2194 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total | BG confirmed | 3272 Episodes |
Secondary
Number of Treatment Emergent Injection Site Reactions
Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP and excluding the events occurring in the run-in period. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Injection Site Reactions | 11 Events |
| Faster Aspart (Post) | Number of Treatment Emergent Injection Site Reactions | 31 Events |
| NovoRapid (Meal) | Number of Treatment Emergent Injection Site Reactions | 17 Events |
Secondary
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 1 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 1916 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 919 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 3 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 9 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 2 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 7 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 12 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 2182 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 926 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 1796 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 865 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 0 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 9 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 1 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 13 Episodes |
Secondary
Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 1060 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 793 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 1 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 1059 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 1790 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 961 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 1277 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 1277 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 1850 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 1617 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 1067 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 1 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 782 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 1066 Episodes |
Secondary
Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 0 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 178 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 77 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 0 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 1 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 2 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 113 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 51 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 157 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 55 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 0 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 1 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 0 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 1 Episodes |
Secondary
Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 119 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 94 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 0 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 119 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 137 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 49 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 66 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 66 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 100 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 109 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 105 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 0 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 85 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 105 Episodes |
Secondary
Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 2 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 1125 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 421 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 1 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 6 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 1 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 1 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 6 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 882 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 268 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 1016 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 303 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 0 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 7 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 1 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 4 Episodes |
Secondary
Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 717 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 572 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 2 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 715 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 838 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 414 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 1 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 504 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 505 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 653 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 730 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 601 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 1 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 495 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 600 Episodes |
Secondary
Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 3 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 3041 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 1340 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 4 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 15 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 2 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 0 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 1 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 8 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 18 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 3064 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 1194 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Documented symptomatic | 2812 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Asymptomatic | 1168 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Unclassifiable | 0 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Probable symptomatic | 16 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Severe | 2 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification | Pseudo-hypoglycaemia | 17 Episodes |
Secondary
Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification
Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.
Time frame: Week 0-26
Population: SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 1777 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 1365 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 3 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 1774 Episodes |
| Faster Aspart (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 2628 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 1375 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 1 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 1781 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 1782 Episodes |
| Faster Aspart (Post) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 2503 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Unclassifiable | 2347 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed | 1668 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe | 2 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | Severe or BG confirmed symptomatic | 1277 Episodes |
| NovoRapid (Meal) | Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification | BG confirmed | 1666 Episodes |
Secondary
Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines
Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.
Time frame: Week 26
Population: FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines | Yes | 42.3 Percentage of participants |
| Faster Aspart (Meal) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines | No | 57.7 Percentage of participants |
| Faster Aspart (Post) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines | Yes | 31.7 Percentage of participants |
| Faster Aspart (Post) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines | No | 68.3 Percentage of participants |
| NovoRapid (Meal) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines | Yes | 39.5 Percentage of participants |
| NovoRapid (Meal) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines | No | 60.5 Percentage of participants |
Secondary
Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia
Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to ISPAD guidelines, without severe hypoglycaemia was evaluated after 26 weeks of randomisation. Severe hypoglycaemia according to ISPAD guidelines: hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose). The results are based on the last in-trial value.
Time frame: Week 26
Population: FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia | Yes | 41.9 Percentage of participants |
| Faster Aspart (Meal) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia | No | 58.1 Percentage of participants |
| Faster Aspart (Post) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia | Yes | 30.9 Percentage of participants |
| Faster Aspart (Post) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia | No | 69.1 Percentage of participants |
| NovoRapid (Meal) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia | Yes | 38.4 Percentage of participants |
| NovoRapid (Meal) | Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia | No | 61.6 Percentage of participants |
Secondary
Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)
Percentage of time spent with IG \<=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG \>10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time frame: Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG >10 mmol/L | 40.40 Percentage of time | Standard Deviation 14.8 |
| Faster Aspart (Meal) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG <=3.9 mmol/L | 5.97 Percentage of time | Standard Deviation 4.59 |
| Faster Aspart (Meal) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG <=2.5 mmol/L | 1.09 Percentage of time | Standard Deviation 1.5 |
| Faster Aspart (Meal) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG <=3.0 mmol/L | 2.19 Percentage of time | Standard Deviation 2.35 |
| Faster Aspart (Meal) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG >12 mmol/L | 26.09 Percentage of time | Standard Deviation 12.82 |
| Faster Aspart (Post) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG <=3.9 mmol/L | 6.25 Percentage of time | Standard Deviation 5.68 |
| Faster Aspart (Post) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG <=2.5 mmol/L | 1.80 Percentage of time | Standard Deviation 3.21 |
| Faster Aspart (Post) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG <=3.0 mmol/L | 2.90 Percentage of time | Standard Deviation 4.06 |
| Faster Aspart (Post) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG >10 mmol/L | 40.60 Percentage of time | Standard Deviation 14.38 |
| Faster Aspart (Post) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG >12 mmol/L | 25.67 Percentage of time | Standard Deviation 13.6 |
| NovoRapid (Meal) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG >12 mmol/L | 28.62 Percentage of time | Standard Deviation 16.83 |
| NovoRapid (Meal) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG >10 mmol/L | 42.47 Percentage of time | Standard Deviation 17.51 |
| NovoRapid (Meal) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG <=2.5 mmol/L | 1.34 Percentage of time | Standard Deviation 1.9 |
| NovoRapid (Meal) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG <=3.9 mmol/L | 5.97 Percentage of time | Standard Deviation 5.38 |
| NovoRapid (Meal) | Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) | Time spent with IG <=3.0 mmol/L | 2.48 Percentage of time | Standard Deviation 2.92 |
Secondary
Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included
Percentage of time spent within IG target 4.0-10.0 mmol/L (71-180 mg/dL), both included based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.
Time frame: Week 26
Population: FAS. Number of participants analysed = number of participants contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included | 53.00 Percentage of time | Standard Deviation 12.15 |
| Faster Aspart (Post) | Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included | 52.56 Percentage of time | Standard Deviation 14.08 |
| NovoRapid (Meal) | Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included | 51.03 Percentage of time | Standard Deviation 16.25 |