Trial Profile
A Randomized, Double-Blind, Placebo-Controlled, 2-Arm Parallel-Group, Multicenter 24-Week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of a Sulfonylurea in Patients With Type 2 Diabetes Not Adequately Controlled With Sulfonylurea.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 17 Sep 2021
Price :
$35
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At a glance
- Drugs Lixisenatide (Primary)
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms GETGOAL-S
- Sponsors Sanofi
- 01 Sep 2016 Results of post-hoc pooled analysis of this and other phase III trial ( GetGoal-M) 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.