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 insuli
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 17.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-005500-33-ES
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 358
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method