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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jun 2018

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

    • 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.
    • 29 Jun 2018 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending inclusion of Bydureon (2mg prolonged-release suspension for injection) BCise device as a new formulation within the marketing authorisation for Bydureon (exenatide extended-release) for the treatment of type-2 diabetes. The CHMP recommendation is based on the clinical trials DURATION-NEO-1 and NEO-2, according to an AstraZeneca media release.
    • 10 Jun 2017 Biomarkers information updated
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