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Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety

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Trial Profile

Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2024

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At a glance

  • Drugs Insulin icodec (Primary) ; Insulin aspart; Insulin degludec
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms ONWARDS 6
  • 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 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 European Commission within approximately two months.
    • 17 Oct 2023 Results comparing the efficacy and safety of once-weekly subcutaneous insulin icodec (icodec) and once-daily insulin degludec. published in the Lancet
    • 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.
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