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.
Phase of Trial: Phase III
Latest Information Update: 01 Feb 2017
At a glance
- Drugs Lixisenatide (Primary)
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms GETGOAL-MONO
- Sponsors Sanofi
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History