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

• Register: EUCTR
• Last refreshed on: 17 September 2018
• Main ID: EUCTR2014-002568-33-DE
• Date of registration: 14/03/2016
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public 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
• Scientific 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 - onset®7
• Date of first enrolment: 12/04/2016
• Target sample size: 750
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002568-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Partly double-blind, partly open, treat-to-target; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Czech Republic, Estonia, European Union, Finland, Germany, India, Israel, Japan, Latvia, Lithuania, Poland, Russian Federation, Serbia, Turkey, Ukraine, United States

Contacts

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female, 1 = age < 18 years at the time of signing informed consent and < 18 years at the time of randomisation
2. Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines)
3. Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or NPH insulin for at least 90 days prior to the screening visit
4. HbA1c = 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit

Are the trial subjects under 18? yes
Number of subjects for this age range: 750
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit
2. 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Diabetes Mellitus, Type 1
MedDRA version: 19.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861

Intervention(s)

Product Name: Faster aspart 3 ml Penfill
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: NovoRapid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Tresiba
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Change from baseline in HbA1c

Secondary Objective: 1. To confirm the effect of treatment with post-meal faster-acting insulin aspart in terms of glycaemic control by comparing it to meal-time NovoRapid®, both in combination with insulin degludec, using a non-inferiority approach in children and adolescents with type 1 diabetes.
2. To confirm superiority of treatment with meal-time faster-acting insulin aspart in terms of glycaemic control by comparing it to meal-time NovoRapid®, both in combination with insulin degludec in children and adolescents with type 1 diabetes.
3. To compare the effect and safety of treatment with meal-time faster-acting insulin aspart vs. mealtime NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.
4. To compare the effect and safety of treatment with post-meal faster-acting insulin aspart vs. mealtime NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.

Timepoint(s) of evaluation of this end point: 26 weeks after randomisation

Main Objective: To confirm the effect of treatment with meal-time faster-acting insulin aspart in terms of glycaemic control by comparing it to meal-time NovoRapid®, both in combination with insulin degludec using a non-inferiority approach in children and adolescents with type 1 diabetes

Secondary Outcome(s)

Secondary end point(s): 1. Change from baseline in 8-point self-measured plasma glucose (SMPG) profile (8-point profile):
- Mean postprandial glucose (PPG) and PPG increment over all three meals
2. Change from baseline in fasting plasma glucose (FPG)
3. Number of treatment emergent adverse events (AEs)

Timepoint(s) of evaluation of this end point: For all secondary endpoints:
26 weeks after randomisation

Secondary ID(s)

NN1218-4101

2014-002568-33-BG

Source(s) of Monetary Support

Novo Nordisk A/S