A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen With Insulin Aspart as Bolus Insulin, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN: Young 1)

Trial Profile

A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen With Insulin Aspart as Bolus Insulin, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN: Young 1)

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2017

At a glance

  • Drugs Insulin aspart (Primary) ; Insulin degludec (Primary) ; Insulin detemir
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms BEGIN; BEGIN-Young-1
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 19 Dec 2016 According to Novo Nordisk media release, company has submitted the supplemental New Drug Application (sNDA) in children and adolescents with type 1 diabetes aged 1 to 17 based on results of this trial.
    • 16 Sep 2016 According to a Novo Nordisk media release, the Committee for Medicinal Products for Human Use, has adopted a positive opinion to extend the use of NovoRapid (insulin aspart) in the European Union for children with diabetes from as young as one year old.
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