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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Mar 2017

At a glance

  • Drugs Insulin detemir (Primary) ; Insulin aspart; Insulin suspension isophane
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 24 Oct 2012 Primary endpoint 'Proportion-of-glycosylated-haemoglobin' has been met.
    • 29 Jun 2012 Official title amended as reported by European Clinical Trials Database.(Parent trial: EudraCT2006-000051-18).
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