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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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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: 15 Jul 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

    • 10 Jul 2024 According to Novo Nordisk media release, In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed. Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to fulfil the requests. Novo Nordisk does not expect to be able to fulfil the requests during 2024.
    • 10 Jul 2024 According to Novo Nordisk media release, the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus.
    • 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.
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