Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (With or Without Sulfonylurea): a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With 24-week Treatment Period
Phase of Trial: Phase III
Latest Information Update: 27 Jul 2016
At a glance
- Drugs Lixisenatide (Primary) ; Metformin; Sulfonylureas
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms GetGoal-M-Asia
- Sponsors Sanofi
- 07 Jun 2017 Biomarkers information updated
- 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.