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A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Background Therapy With Pioglitazone Alone or in Combination With Metformin.

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Trial Profile

A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Background Therapy With Pioglitazone Alone or in Combination With Metformin.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2018

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At a glance

  • Drugs Empagliflozin (Primary) ; Metformin; Pioglitazone
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms EMPA-REG-PIO
  • Sponsors Boehringer Ingelheim; Eli Lilly and Company

Most Recent Events

  • 31 Jul 2018 Results of pooled analysis (see profiles: 56615, 57731, 58105, 58520 and 60013) investigating the effect of empagliflozin on aminotransferases published in the Diabetologia
  • 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.

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