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Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus. A 52 week Randomised, Open-label, Active-controlled Trial with a 52-week Extension Phase

Trial Profile

Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus. A 52 week Randomised, Open-label, Active-controlled Trial with a 52-week Extension Phase

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2022

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At a glance

  • Drugs Semaglutide (Primary) ; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms PIONEER 7
  • Sponsors Novo Nordisk

Most Recent Events

  • 23 Sep 2022 Results of an exploratory analysis assessing time spent by patients with HbA1c <7.0% (53 mmol/mol), and likelihood of maintaining this glycaemic control using data from four clinical studies: PIONEER-2, PIONEER-3, PIONEER-4 and PIONEER-7 presented at the 58th Annual Meeting of the European Association for the Study of Diabetes.
  • 29 Jun 2021 Data from PIONEER 1-5, 7 AND 8 were used to assess BW loss, presented at the 81st 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.

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