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A randomised, controlled, parallel, open-labelled, multinational, trial comparing the efficacy and safety of step-wise addition of insulin aspart (NovoRapid) according to the largest meals (Basic Basal Plus regimen) or the largest prandial increments (Advanced Basal Plus regimen) in combination with once daily insulin detemir (Levemir) and OAD treatment, in subjects with type 2 diabetes

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Trial Profile

A randomised, controlled, parallel, open-labelled, multinational, trial comparing the efficacy and safety of step-wise addition of insulin aspart (NovoRapid) according to the largest meals (Basic Basal Plus regimen) or the largest prandial increments (Advanced Basal Plus regimen) in combination with once daily insulin detemir (Levemir) and OAD treatment, in subjects with type 2 diabetes

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 06 Oct 2021

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At a glance

  • Drugs Insulin aspart (Primary) ; Insulin detemir (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms STEPwise
  • Sponsors Novo Nordisk

    • Most Recent Events

    • 28 Jun 2012 Planned number of patients changed from 358 to 512 as reported by European Clinical Trials Database.
    • 28 Jun 2012 Additional trial location (France) added as reported by European Clinical Trials Database.
    • 20 Sep 2010 Results were presented in an abstract at 46th Annual Meeting of the European Association for the Study of Diabetes.
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