Trial Profile
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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 26 Jun 2019
Price :
$35
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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
- 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.
- 15 Jun 2015 Results (pooled analysis of four, 24 week, phase III trials - NCT01159600, NCT01719003, NCT01778049, 3090558) presented at the 25th European Meeting on Hypertension and Cardiovascular Protection.