A 52-Week, Multinational, Multi-Centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Children and Adolescents 2-16 years with Type 1 Diabet...

Update Il y a 4 ans
Reference: EUCTR2006-000051-18

A 52-Week, Multinational, Multi-Centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Children and Adolescents 2-16 years with Type 1 Diabetes on a Basal-Bolus Regimen with Insulin Aspart as Bolus Insulin

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Extract

Primary objective: To compare the glycaemic control, measured as HbA1c, of insulin detemir administered once or twice daily plus mealtime insulin aspart with NPH insulin administered once or twice daily plus mealtime insulin aspart in children and adolescents with type 1 diabetes.


Inclusion criteria

  • type -I diabetes