A trial investigating the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals versus insulin detemir once or twice daily plus meal time insulin aspart in children and adolescents with type 1 diabetes mellitus

• Register: EUCTR
• Last refreshed on: 3 November 2014
• Main ID: EUCTR2012-003566-41-ES
• Date of registration: 12/07/2013
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A trial investigating the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals versus insulin detemir once or twice daily plus meal time insulin aspart in children and adolescents with type 1 diabetes mellitus
• Scientific title: A trial investigating the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals versus insulin detemir once or twice daily plus meal time insulin aspart in children and adolescents with type 1 diabetes mellitus
• Date of first enrolment: 29/08/2013
• Target sample size: 346
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003566-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: Treat-to-target If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Belgium, Brazil, Canada, Croatia, European Union, India, Israel, Macedonia, the former Yugoslav Republic of, Russian Federation, Serbia, Slovenia, South Africa, Spain, 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) Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
2) Subjects diagnosed with type 1 diabetes mellitus
3) Age: 1 to <18 years of age at randomisation
4) HbA1c ? 11.0%
Are the trial subjects under 18? yes
Number of subjects for this age range: 346
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) Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator
2) More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening)
3) Any chronic disorder or significant concomitant disease, which in the investigator?s opinion might jeopardise the subject?s safety or compliance with the protocol


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: 16.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861

Intervention(s)

Trade Name: Ryzodeg 100 U Penfill
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit: nmol/ml nanomole(s)/millilitre
Concentration type: equal
Concentration number: 420-
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Concentration unit: nmol/ml nanomole(s)/millilitre
Concentration type: equal
Concentration number: 180-

Trade Name: NovoRapid 100 U/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: Levemir 100 U/ml Penfill
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN DETEMIR
CAS Number: 169148-63-4
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 (%)

Timepoint(s) of evaluation of this end point: After 16 weeks of treatment

Main Objective: To confirm the efficacy of insulin degludec/insulin aspart administered once daily plus meal-time insulin aspart for the remaining meals in controlling glycaemia with respect to change from baseline in HbA1c after 16 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c between insulin degludec/insulin aspart + meal-time insulin aspart for the remaining meals and insulin detemir + meal-time insulin aspart to a non-inferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%.

Secondary Objective: To compare the efficacy and safety between the two treatment groups after 16 weeks of treatment

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: After 16 weeks of treatment

Secondary end point(s): - Change from baseline in fasting plasma glucose
- Incidence of treatment emergent adverse events (TEAEs)
- Hypoglycaemia:
- Number of treatment emergent confirmed hypoglycaemic episodes (PG<3.1 mmol/L (56 mg/dL) or severe hypoglycaemia )
- Number of treatment emergent nocturnal confirmed hypoglycaemic episodes
- Hyperglycaemia:
- Number of hyperglycaemic episodes (PG > 14.0 mmol/L (250 mg/dL) where subject looks/feels ill
- Number of hyperglycaemic episodes (PG > 14.0 mmol/L (250 mg/dL) where subject looks/feels ill with ketosis (blood ketones > 1.5 mmol/L)

Secondary ID(s)

2012-003566-41-SI

NN5401-3816

Source(s) of Monetary Support

Novo Nordisk A/S