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A 26-week double blinded, multiregional, trial comparing the effect and safety of once weekly insulin icodec and once daily insulin degludec 100 units/mL, both in combination with non-insulin anti-diabetic drugs, in insulin naïve subjects with type 2 diabetes

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Trial Profile

A 26-week double blinded, multiregional, trial comparing the effect and safety of once weekly insulin icodec and once daily insulin degludec 100 units/mL, both in combination with non-insulin anti-diabetic drugs, in insulin naïve subjects with type 2 diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2024

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At a glance

  • Drugs Insulin icodec (Primary) ; Antihyperglycaemics; Insulin degludec
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms ONWARDS 3
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 21 Mar 2024 According to Novo Nordisk media release, the company announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Awiqli (the brand name for once-weekly basal insulin icodec) for treatment of diabetes in adults. The positive CHMP opinion is based on results from the ONWARDS phase 3a clinical trial programme. The company expects to receive final marketing authorisation from the Europ
    • 06 Oct 2023 Results assessing the impact of icodec use during and around hospitalisation in participants receiving icodec across all six trials (NCT04460885; NCT04770532; NCT04795531; NCT04880850; NCT04760626 and NCT04848480, presented at the 59th Annual Meeting of the European Association for the Study of Diabetes.
    • 06 Oct 2023 Results assessing Efficacy and safety of once-weekly insulin icodec versus once daily insulin degludec in adults with insulin-naive type 2 diabetes presented at the 59th Annual Meeting of the European Association for the Study of Diabetes
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