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A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes

Trial Profile

A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2025

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At a glance

  • Drugs Insulin icodec (Primary) ; Insulin glargine
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms ONWARDS 1
  • Sponsors Novo Nordisk

Most Recent Events

  • 10 Jun 2025 According to a Novo Nordisk Media Release, data from this study will be showcased at the upcoming American Diabetes Association (ADA) 85th Scientific Sessions taking place in Chicago US, 20 - 23 June 2025.
  • 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.
  • 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.

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