A 24-week phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of twice daily oral administration of empagliflozin + metformin compared with the individual components of empagliflozin or metformin in drug naive patients with type 2 diabetes mellitus
Phase of Trial: Phase III
Latest Information Update: 04 Aug 2016
At a glance
- Drugs Empagliflozin/metformin (Primary) ; Empagliflozin; Metformin
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms Boehringer GP study
- Sponsors Boehringer Ingelheim Pharmaceuticals
- 07 Jun 2017 Biomarkers information updated
- 04 Aug 2016 Results (n=1364) published in the Diabetes Care (2016).
- 23 Jul 2015 According to an Eli Lilly media release, the U.S. FDA has issued a Complete Response Letter for empagliflozin/metformin [Synjardy] for the treatment of adults with type 2 diabetes.