A trial investigating efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with metformin and diet/exercise on glycaemic control in children and adolescents with type 2 diabetes insufficiently controlled on metformin ± other oral antidiabetic drug(s) ± basal insulin

• Register: EUCTR
• Last refreshed on: 4 July 2016
• Main ID: EUCTR2013-005500-33-HR
• Date of registration: 05/11/2014
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: A trial investigating efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with metformin and diet/exercise on glycaemic control in children and adolescents with type 2 diabetes insufficiently controlled on metformin ± other oral antidiabetic drug(s) ± basal insulin
• Scientific title: A 26-week open label, randomised, 2-armed, parallel group, multi-centre trial investigating efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn in combination with metformin and diet/exercise on glycaemic control in children and adolescents with type 2 diabetes insufficiently controlled on metformin ± other oral antidiabetic drug(s) ± basal insulin
• Date of first enrolment: 02/10/2014
• Target sample size: 358
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005500-33
• 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: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Brazil, Canada, China, Croatia, European Union, Germany, Greece, Hungary, India, Israel, Japan, Macedonia, the former Yugoslav Republic of, Malaysia, Mexico, Portugal, Russian Federation, Serbia, South Africa, Spain, Taiwan, Turkey, 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 from the subject or a legally acceptable representative (LAR) and child assent from the subject 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. Male or female, 10 years = age =17 years at the time of signing informed consent/assent
3. Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening
4. Treated with a stable dose of metformin (1000-2000 mg/day) for at least 3 months prior to screening ± other OAD(s) ± basal insulin
5. HbA1c; = 7.0% and = 10.5% (= 53 mmol/mol and = 91 mmol/mol) at screening
Are the trial subjects under 18? yes
Number of subjects for this age range: 358
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. Maturity onset diabetes of the young (MODY)
2. Fasting C-peptide at screening <0.6 ng/mL
3. Impaired liver function defined as alanine aminotransferase (ALT) = 2.5 times upper normal limit
4. Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator


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

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2
MedDRA version: 17.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

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

Intervention(s)

Trade Name: Levemir
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN DETEMIR
CAS Number: 169148-63-4
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Insulatard
Pharmaceutical Form: Suspension for injection in pre-filled pen
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061-68-0
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: From baseline to Week 26

Primary end point(s): Change in HbA1c

Secondary Objective: In children and adolescents (aged 10–17 years) with type 2 diabetes, who are insufficiently treated with metformin ± other OAD(s) ± basal insulin:
1. To compare the efficacy of insulin detemir in combination with metformin and diet/exercise versus insulin NPH in combination with metformin and diet/exercise on body weight, after 26 weeks of treatment
2. To compare the proportion of subjects achieving glycaemic control without experiencing severe hypoglycaemia, after 26 weeks of treatment, for insulin detemir in combination with metformin and diet/exercise versus insulin NPH in combination with metformin) and diet/exercise.
3. To assess and compare the safety and tolerability of insulin detemir in combination with metformin and diet/exercise versus insulin NPH in combination with metformin and diet/exercise, during 26 weeks of treatment.

Main Objective: To compare the efficacy of insulin detemir in combination with metformin and diet/exercise versus insulin Neutral Protamine Hagedorn (NPH) in combination with metformin and diet/exercise in controlling glycaemia, after 26 weeks of treatment, in children and adolescents (aged 10–17 years) with type 2 diabetes, who are insufficiently treated with metformin ± other OAD(s) ± basal insulin.

Secondary Outcome(s)

Secondary end point(s): 1. Change in body weight standard deviation score (SDS)
2. Proportion of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment
3. Proportion of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment
4. Total number of treatment emergent nocturnal (23:00-06:59) severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes
5. Total number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes
6. Incidence of adverse events (AEs)

Timepoint(s) of evaluation of this end point: 1. From baseline to Week 26
2. - 3. At Week 26
4. - 6. During 26 weeks of treatment

Secondary ID(s)

2013-005500-33-HU

NN304-4093

Source(s) of Monetary Support

Novo Nordisk A/S