A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter 24-Week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin.
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-M
- Sponsors Sanofi
- 01 Sep 2016 Results of post-hoc pooled analysis of this and other phase III trial ( GetGoal-S) published in the Diabetes Therapy (2016).
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History