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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 (onset®7)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Faster-acting insulin aspart

insulin aspart

insulin degludec

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Meal-time faster-acting insulin aspart and insulin degludec

Meal-time NovoRapid® (insulin aspart) and insulin degludec

Post-meal faster-acting insulin aspart and insulin degludec

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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®).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification

Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification

Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification

Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification

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

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

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

Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02670915

First Posted

January 27, 2016

Last Updated

May 22, 2019

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02670915

Brief Title

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

Acronym

onset®7

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

May 4, 2016 (Actual)

Primary Completion Date

February 5, 2018 (Actual)

Study Completion Date

March 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

834 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Meal-time faster-acting insulin aspart and insulin degludec

Arm Type

Experimental

Arm Title

Meal-time NovoRapid® (insulin aspart) and insulin degludec

Arm Type

Active Comparator

Arm Title

Post-meal faster-acting insulin aspart and insulin degludec

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Faster-acting insulin aspart

Intervention Description

For subcutaneous (s.c., under the skin) injection once daily.

Intervention Type

Drug

Intervention Name(s)

insulin aspart

Intervention Description

For subcutaneous (s.c., under the skin) injection once daily.

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

For subcutaneous (s.c., under the skin) injection once daily.

Primary Outcome Measure Information:

Title

Change in the Percentage of HbA1c

Description

Time Frame

Week 0, Week 26

Secondary Outcome Measure Information:

Title

Change in 8-point SMPG Profile: Mean PPG Over All Three Meals

Description

Time Frame

Week 0, Week 26

Title

Change in 8-point SMPG Profile: PPG Increment Over All Three Meals

Description

Time Frame

Week 0, Week 26

Title

Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG

Description

Time Frame

Week 0, Week 26

Title

Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment

Description

Time Frame

Week 0, Week 26

Title

Change in 8-point SMPG Profile: Mean of the 8-point Profile

Description

Time Frame

Week 0, Week 26

Title

Fluctuation in the 8-point SMPG Profile

Description

Time Frame

Week 26

Title

Change in FPG

Description

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

Title

Change in 1,5-anhydroglucitol

Description

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

Title

Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines

Description

Time Frame

Week 26

Title

Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia

Description

Time Frame

Week 26

Title

Insulin Dose (Units/Day): Total Basal

Description

Time Frame

Week 26

Title

Insulin Dose (Units/Day): Total Bolus

Description

Time Frame

Week 26

Title

Insulin Dose (Units/Day): Individual Meal Insulin Dose

Description

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

Title

Insulin Dose (Units/kg/Day): Total Basal

Description

Time Frame

Week 26

Title

Insulin Dose (Units/kg/Day): Total Bolus

Description

Time Frame

Week 26

Title

Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose

Description

Time Frame

Week 26

Title

Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL])

Description

Time Frame

Week 0, Week 26

Title

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)

Description

Time Frame

Week 26

Title

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)

Description

Time Frame

Week 26

Title

Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included

Description

Time Frame

Week 26

Title

Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal)

Description

Time Frame

Week 0, Week 26

Title

Change in Mean IG Peak After Start of Meal

Description

Time Frame

Week 0, Week 26

Title

Change in Mean Time to the IG Peak After Meal

Description

Time Frame

Week 0, Week 26

Title

Change in 30-minute PPG

Description

Time Frame

Week 0, Week 26

Title

Change in 30-minute PPG Increment

Description

Time Frame

Week 0, Week 26

Title

Change in 1-hour PPG

Description

Time Frame

Week 0, Week 26

Title

Change in 1-hour PPG Increment

Description

Time Frame

Week 0, Week 26

Title

Change in 2-hour PPG

Description

Time Frame

Week 0, Week 26

Title

Change in 2-hour PPG Increment

Description

Time Frame

Week 0, Week 26

Title

Change in AUCIG,0-15min

Description

Time Frame

Week 0, Week 26

Title

Change in AUCIG,0-30min

Description

Time Frame

Week 0, Week 26

Title

Change in AUCIG,0-1h

Description

Time Frame

Week 0, Week 26

Title

Change in AUCIG,0-2h

Description

Time Frame

Week 0, Week 26

Title

Change in AUCIG,0-4h

Description

Time Frame

Week 0, Week 26

Title

Change in Time to the IG Peak After Start of Meal

Description

Time Frame

Week 0, Week 26

Title

Change in IG Peak After Start of Meal

Description

Time Frame

Week 0, Week 26

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total

Description

Time Frame

Week 0-26

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime

Description

Time Frame

Week 0-26

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)

Description

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

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total

Description

Time Frame

Week 0-26

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime

Description

Time Frame

Week 0-26

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)

Description

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

Title

Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification

Description

Time Frame

Week 0-26

Title

Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification

Description

Time Frame

Week 0-26

Title

Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification

Description

Time Frame

Week 0-26

Title

Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification

Description

Time Frame

Week 0-26

Title

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

Description

Time Frame

Week 0-26

Title

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

Description

Time Frame

Week 0-26

Title

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

Description

Time Frame

Week 0-26

Title

Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification

Description

Time Frame

Week 0-26

Title

Number of Treatment Emergent Adverse Events (AEs)

Description

Time Frame

Week 0-26

Title

Number of Treatment Emergent Injection Site Reactions

Description

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

Title

Change in Physical Examination

Description

Time Frame

Week 0, Week 26

Title

Change in Vital Sign: Blood Pressure

Description

Time Frame

Week 0, Week 26

Title

Change in Vital Sign: Pulse

Description

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

Title

Change in Body Weight

Description

Time Frame

Week 0, Week 26

Title

Change in Height

Description

Time Frame

Week 0, Week 26

Title

Change in Body Mass Index

Description

Time Frame

Week 0, Week 26

Title

Change in SD Score of Body Weight

Description

Time Frame

Week 0, Week 26

Title

Change in SD Score of Body Mass Index

Description

Time Frame

Week 0, Week 26

Title

Change in Haematology: Haemoglobin

Description

Time Frame

Week 0, Week 26

Title

Change in Haematology: Haematocrit

Description

Time Frame

Week 0, Week 26

Title

Change in Haematology: Erythrocytes

Description

Time Frame

Week 0, Week 26

Title

Change in Haematology: Thrombocytes

Description

Time Frame

Week 0, Week 26

Title

Change in Haematology: Leukocytes

Description

Time Frame

Week 0, Week 26

Title

Change in Biochemistry: Creatinine

Description

Time Frame

Week 0, Week 26

Title

Change in Biochemistry: Alanine Aminotransferase (ALT)

Description

Time Frame

Week 0, Week 26

Title

Change in Biochemistry: Aspartate Aminotransferase (AST)

Description

Time Frame

Week 0, Week 26

Title

Change in Biochemistry: Alkaline Phosphatase (AP)

Description

Time Frame

Week 0, Week 26

Title

Change in Biochemistry: Sodium

Description

Time Frame

Week 0, Week 26

Title

Change in Biochemistry: Potassium

Description

Time Frame

Week 0, Week 26

Title

Change in Biochemistry: Albumin

Description

Time Frame

Week 0, Week 26

Title

Change in Biochemistry: Total Bilirubin

Description

Time Frame

Week 0, Week 26

Title

Change in Lipid Profile: Total Cholesterol

Description

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

Title

Change in Lipid Profile: High Density Lipoproteins (HDL)

Description

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

Title

Change in Lipid Profile: Low Density Lipoproteins (LDL)

Description

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

Title

Change in Anti-insulin Aspart Antibody Development: Specific

Description

Time Frame

Week 0, Week 26

Title

Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin

Description

Time Frame

Week 0, Week 26

Title

Change in Anti-insulin Aspart Antibody Development: Total

Description

Time Frame

Week 0, Week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85053

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95821

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ventura

State/Province

California

ZIP/Postal Code

93003

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30339

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83712

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404-7596

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Neptune

State/Province

New Jersey

ZIP/Postal Code

07753

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14203

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27610

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58122

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Hradec Kralove

ZIP/Postal Code

50005

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Opava

ZIP/Postal Code

746001

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Ostrava - Poruba

ZIP/Postal Code

70852

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Pardubice

ZIP/Postal Code

53203

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha

ZIP/Postal Code

10034

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Usti nad Labem

ZIP/Postal Code

40113

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Novo Nordisk Investigational Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

Novo Nordisk Investigational Site

City

Espoo

ZIP/Postal Code

02740

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

OYS

ZIP/Postal Code

90029

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Seinäjoki

ZIP/Postal Code

60220

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Ludwigshafen

ZIP/Postal Code

67059

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Münster

ZIP/Postal Code

48155

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Neuwied

ZIP/Postal Code

56564

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Oldenburg

ZIP/Postal Code

23758

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Saint Ingbert-Oberwürzbach

ZIP/Postal Code

66386

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500003

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500072

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380007

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kochi

State/Province

Kerala

ZIP/Postal Code

682041

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Indore

State/Province

Madhya Pradesh

ZIP/Postal Code

452010

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400010

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600 013

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kolkata

ZIP/Postal Code

700026

Country

India

Facility Name

Novo Nordisk Investigational Site

City

New Delhi

ZIP/Postal Code

110060

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Petah Tikva

ZIP/Postal Code

49202

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Tel Aviv

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Ancona

ZIP/Postal Code

60123

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Chieti

ZIP/Postal Code

66100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Verona

ZIP/Postal Code

37126

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Amagasaki-shi, Hyogo

ZIP/Postal Code

661-0965

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Chuo-shi, Yamanashi

ZIP/Postal Code

409 3898

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Hiroshima-shi, Hiroshima

ZIP/Postal Code

734-8530

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Iruma-gun, Saitama

ZIP/Postal Code

350 0495

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kitakyushu,Fukuoka

ZIP/Postal Code

8078556

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kitakyushu-shi, Fukuoka

ZIP/Postal Code

806-8501

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kobe-shi, Hyogo

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kobe-shi, Hyogo

ZIP/Postal Code

657-0846

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kochi-shi, Kochi

ZIP/Postal Code

780 0952

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kofu, Yamanashi

ZIP/Postal Code

400-0027

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kumamoto-shi, Kumamoto

ZIP/Postal Code

860 8556

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kure-shi, Hiroshima

ZIP/Postal Code

737-0023

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Maebashi-shi, Gunma

ZIP/Postal Code

371-8511

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Matsumoto-shi, Nagano,

ZIP/Postal Code

399-8701

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Matsuyama-shi, Ehime

ZIP/Postal Code

790-8524

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Musashino-shi, Tokyo

ZIP/Postal Code

180 0023

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Niigata-shi, Niigata

ZIP/Postal Code

950 1197

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Niigata-shi, Niigata

ZIP/Postal Code

951 8520

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Okayama Kita-ku, Okayama

ZIP/Postal Code

700-8607

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Okayama-shi, Okayama

ZIP/Postal Code

700-0013

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Okayama-shi, Okayama

ZIP/Postal Code

701-1192

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Osaka-shi, Osaka

ZIP/Postal Code

545 8586

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Ota-shi, Gunma

ZIP/Postal Code

373-8585

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Otsu-shi, Shiga

ZIP/Postal Code

520-0804

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Saga-shi, Saga

ZIP/Postal Code

840-0801

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Sendai-shi, Miyagi

ZIP/Postal Code

980 8574

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Suzaka-shi ,Nagano

ZIP/Postal Code

382-0091

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

101-8309

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

157 8535

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

162 8666

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tsu-shi, Mie

ZIP/Postal Code

514 0125

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Yokohama-shi, Kanagawa

ZIP/Postal Code

232-0024

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Yokosuka-shi, Kanagawa

ZIP/Postal Code

238-8567

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Riga

ZIP/Postal Code

LV1004

Country

Latvia

Facility Name

Novo Nordisk Investigational Site

City

Kaunas

ZIP/Postal Code

50009

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

ZIP/Postal Code

04-736

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wroclaw

ZIP/Postal Code

50-368

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Facility Name

Novo Nordisk Investigational Site

City

Kazan

ZIP/Postal Code

420073

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

125373

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630048

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Rostov-on-Don

ZIP/Postal Code

344013

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

191036

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Samara

ZIP/Postal Code

443079

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saratov

ZIP/Postal Code

410054

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Ufa

ZIP/Postal Code

450106

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11070

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Nis

ZIP/Postal Code

18 000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Adana

ZIP/Postal Code

01130

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Antalya

ZIP/Postal Code

07059

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34668

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

İzmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Dnipro

ZIP/Postal Code

49023

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kharkiv

ZIP/Postal Code

61093

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kharkiv

ZIP/Postal Code

61153

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kiev

ZIP/Postal Code

01021

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Vinnytsia

ZIP/Postal Code

21010

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Zaporizhzhia

ZIP/Postal Code

69063

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

31076415

Citation

Bode BW, Iotova V, Kovarenko M, Laffel LM, Rao PV, Deenadayalan S, Ekelund M, Larsen SF, Danne T. Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial. Diabetes Care. 2019 Jul;42(7):1255-1262. doi: 10.2337/dc19-0009. Epub 2019 May 10.

Results Reference

background

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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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 (onset®7)

Diabetes, Diabetes Mellitus, Type 1

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial