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A Randomized, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus.

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Trial Profile

A Randomized, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2021

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At a glance

  • Drugs Exenatide (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms DURATION-5
  • Sponsors Amylin Pharmaceuticals; Bristol-Myers Squibb

Most Recent Events

  • 05 Oct 2018 Results assessing the efficacy and safety of exenatide once weekly across 10 comparator-controlled studies from the DURATION clinical programme (n=2251) presented at the 54th Annual Meeting of the European Association for the Study of Diabetes
  • 01 Apr 2018 Results of pooled post hoc analysis of this and other ten trials assessing the relationship of heart rate changes with baseline heart rate and identifying patient characteristics associated with changes in heart rate in the Exenatide QW development program published in the Diabetes Therapy
  • 01 Jun 2016 Results of post-hoc analysis assessing the relationship of exenatide exposure with efficacy from patients treated with exenatide once weekly (n=201) published in the Diabetes Therapy.

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