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Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese Subjects With Type 2 Diabetes

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Trial Profile

Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese Subjects With Type 2 Diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2023

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At a glance

  • Drugs Semaglutide (Primary) ; Dulaglutide
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational
  • Acronyms PIONEER 10
  • Sponsors Novo Nordisk

    • Most Recent Events

    • 26 Jun 2023 Results presented at the 83rd Annual Scientific Sessions of the American Diabetes Association
    • 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.
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