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A randomized, open-label, multicenter, comparator-controlled study to examine the effects of exenatide long-acting release on glucose control (HbA1c) and safety in subjects with type 2 diabetes mellitus managed with diet modification and exercise and/or oral anti-diabetic medications

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A randomized, open-label, multicenter, comparator-controlled study to examine the effects of exenatide long-acting release on glucose control (HbA1c) and safety in subjects with type 2 diabetes mellitus managed with diet modification and exercise and/or oral anti-diabetic medications

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Exenatide (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms DURATION-1
  • Sponsors AstraZeneca; 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
    • 16 Sep 2016 Results from extension part over 7 years presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes

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