NCT02131272TerminatedPhase 3
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 the Maximum Tolerated Dose of Metformin and Diet/Exercise on Glycaemic Control in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on the Maximum Tolerated Dose of Metformin ± Other Oral Antidiabetic Drug(s) ± Basal Insulin
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change in HbA1c (Glycosylated Haemoglobin)
Study Overview
Brief Summary
This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with the maximum tolerated dose of metformin and diet/exercise on glycaemic control in children and adolescents with type 2 diabetes insufficiently controlled on the maximum tolerated dose of metformin with or without other oral antidiabetic drug(s) with or without basal insulin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 the maximum tolerated stable dose of metformin for at least 3 months prior to screening or have documented complete metformin intolerance
- •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
Exclusion Criteria
- •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
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 3 months before the day of screening
Arms & Interventions
Insulin detemir and diet/exercise
Experimental
Current OADs i.e. metformin or other OADs are continued unchanged
Intervention: Insulin NPH (Drug)
Insulin detemir and diet/exercise
Experimental
Current OADs i.e. metformin or other OADs are continued unchanged
Intervention: Diet/exercise (Behavioral)
Insulin NPH and diet/exercise
Active Comparator
Current OADs i.e. metformin or other OADs are continued unchanged
Intervention: Insulin detemir (Drug)
Insulin NPH and diet/exercise
Active Comparator
Current OADs i.e. metformin or other OADs are continued unchanged
Intervention: Diet/exercise (Behavioral)
Outcomes
Primary Outcomes
Change in HbA1c (Glycosylated Haemoglobin)
Time Frame: week 0, week 26
Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.
Secondary Outcomes
- Proportion of Subjects Achieving HbA1c Below 7.5%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment(At week 26)
- Change in Body Weight Standard Deviation Score (SDS)(week 0, week 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 Treatment.(At week 26)
- Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0 - 26)
- Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0 - 26)
- Incidence of Adverse Events (AEs)(weeks 0 - 26)
Investigators
Study Sites (1)
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