A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin

Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2018

At a glance

  • Drugs Exenatide (Primary) ; Insulin glargine
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms DURATION 7
  • Sponsors AstraZeneca
  • Most Recent Events

    • 03 Apr 2018 The US FDA has approved BYDUREON (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes (T2D) with inadequate glycemic control, based on the results of this trial, according to an AstraZeneca media release.
    • 03 Apr 2018 Results published in the AstraZeneca media release.
    • 15 Sep 2017 Results assessing individual HbA 1c and weight responses, presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes
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