A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin detemir; Insulin NPH; Diet/exercise
Intervention description: Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OAD's i.e. metformin treatment should continue unchanged during the treatment period.; Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OADs i.e. metformin treatment should continue unchanged during the treatment period.; Intervention will be performed through family based changes in eating and activity behaviours.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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