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A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus

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Trial Profile

A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2018

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At a glance

  • Drugs Exenatide (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms DURATION-NEO-1
  • Sponsors Amylin Pharmaceuticals; 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
    • 30 Aug 2018 Results published in the AstraZeneca Media Release
    • 30 Aug 2018 According to AstraZeneca media release, the European Commission (EC) has approved Bydureon BCise (exenatide 2mg prolonged-release suspension for injection in pre-filled pen) as a new formulation within the marketing authorisation for Bydureon (exenatide extended release) for the treatment of patients with type-2 diabetes.

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