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

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

Completed
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
  • Most Recent Events

    • 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.
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