Conditions: Diabetes Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 42
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Current OADs i.e. metformin or other OADs are continued unchanged arm 2: Current OADs i.e. metformin or other OADs are continued unchanged

Interventions: intervention 1: Insulin detemir intervention 2: Insulin NPH intervention 3: Diet/exercise
Intervention descriptions: intervention 1: 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. intervention 2: 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 3: Intervention will be performed through family based changes in eating and activity behaviours.

Protocol document: