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A Phase IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-Label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control.

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Trial Profile

A Phase IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-Label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Nov 2021

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At a glance

  • Drugs Empagliflozin (Primary) ; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use

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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