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Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes

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Trial Profile

Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2022

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At a glance

  • Drugs Semaglutide (Primary) ; Liraglutide
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms PIONEER 9
  • Sponsors Novo Nordisk

    • Most Recent Events

    • 29 Jun 2020 According to a Novo Nordisk media release, Rybelsus is administered orally once daily and is approved for use in three therapeutic dosages, 3 mg, 7 mg and 14 mg in Japan. The approved label reflects the Japanese studies.
    • 29 Jun 2020 According to a Novo Nordisk media release, the Japanese Ministry of Health, Labour and Welfare has approved Rybelsus (oral semaglutide tablet), for the treatment of adults with type 2 diabetes. The approval of Rybelsus in Japan is based on results from the PIONEER clinical trial programme, a global clinical development programme that comprises eight global and two Japanese phase 3a trials, encompassing more than 9,500 adults with type 2 diabetes, including approximately 1,300 adults from Japan.
    • 04 Apr 2020 According to an Novo Nordisk Media release, European Commission (EC) has granted marketing authorisation for Rybelsus (oral semaglutide), for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic control as an adjunct to diet and exercise. The marketing authorisation applies to all 27 European Union member states and the United Kingdom. Based on the 10 PIONEER clinical trials
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