A Study to evaluate the Efficacy and Safety of Insulin Detemir against Insulin NPH along With Metformin and Diet/Exercise in Children and Adolescents having Type 2 Diabetes
- Conditions
- Health Condition 1: null- Diabetes Mellitus, Type 2Health Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2015/02/005545
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
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
-Male or female, above or equal to 10 years and below or equal to 17 years at the time of signing informed consent/assent
-Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening
-Treated with a stable dose of metformin (1000-2000 mg/day) for at least 3 months prior to screening with or without other OAD(s) with or without basal insulin
HbA1c (glycosylated haemoglobin) above or equal to 7.0% and below or equal to 10.5% (above or equal to 53 mmol/mol and below or equal to 91 mmol/mol) at screening
Maturity onset diabetes of the young (MODY)
Fasting C-peptide at screening below 0.6 ng/mL
Impaired liver function defined as alanine aminotransferase (ALT) above or equal to 2.5 times upper normal limit
Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c (glycosylated haemoglobin)Timepoint: Week 0, Week 26 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Change in body weight standard deviation score (SDS)Timepoint: Week 0, Week 26;Incidence of adverse events (AEs)Timepoint: Weeks 0 - 26;Proportion of subjects achieving HbA1c below 7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatmentTimepoint: At week 26;Proportion of subjects achieving HbA1c below 7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatmentTimepoint: At Week 26;Total number of treatment emergent nocturnal (23:00-06:59) severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodesTimepoint: Weeks 0 - 26;Total number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodesTimepoint: Weeks 0 - 26