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A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

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Trial Profile

A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jul 2021

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At a glance

  • Drugs Exenatide (Primary) ; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms DURATION-NEO-2
  • 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
    • 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.
    • 29 Jun 2018 According to an AstraZeneca media release, This new formulation of once-weekly Bydureon (2mg prolonged-release suspension for injection) for the BCise device is approved by the US FDA.
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