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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: 11 Jul 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

    • 24 Jun 2024 According to Novo Nordisk media release, the company announced that the company has received the manufacturing and marketing approval in Japan for once-weekly Awickli Injection. The approval is based on data from ONWARDS clinical programme and approval has been approved by the Ministry of Health, Labor and Welfare for the treatment of diabetes for which insulin therapy is indicated.
    • 18 Jun 2024 According to Novo Nordisk media release, the company announced that the data of this trial will be discussed at the upcoming 84th Scientific Sessions of the American Diabetes Association (ADA). The conference will be held in-person and virtually from 21 to 24 June 2024 in Orlando, US.
    • 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.

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