A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy

Trial Profile

A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy

Completed
Phase of Trial: Phase II

Latest Information Update: 15 Sep 2017

At a glance

  • Drugs Empagliflozin (Primary) ; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms ENCORE
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 15 Sep 2017 Results of pooled analysis assessing safety of this and other phase I-III studies , presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.
    • 15 Sep 2017 Results of pooled safety analysis in >12,000 patients who were randomized to Empagliflozin (10 mg, 25 mg) or placebo in 15 Phase I-III trials plus 4 extension studies, presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.
    • 16 Sep 2016 Results of a pooled analysis assessing risk of bone fracture presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes
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