Trial Profile
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, 24-Week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 in Two Titration Regimens on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 14 Jan 2020
Price :
$35
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At a glance
- Drugs Lixisenatide (Primary) ; Metformin
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms GETGOAL-F1
- 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.
- 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.
- 08 Dec 2011 Results presented at the 21st World Diabetes Congress.