A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter 12-Week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents.

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter 12-Week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents.

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Dec 2016

At a glance

  • Drugs Lixisenatide (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms GETGOAL-MONO
  • Sponsors Sanofi
  • Most Recent Events

    • 27 Jul 2016 According to a Sanofi media release, lixisenatide (Adlyxin) has been approved by the US FDA for the treatment of adults with typre 2 diabetes based on results from GetGoal clinical program and ELIXA trial.
    • 25 May 2016 According to a Sanofi media release, the New Drug Application (NDA) for Lixisenatide is undergoing FDA review, with decisions anticipated in July 2016.
    • 29 Sep 2015 According to a Sanofi media release, the U.S. FDA has accepted for filing the NDA for lixisenatide for the treatment of adults with type 2 diabetes mellitus.
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