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A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control

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Trial Profile

A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Oct 2021

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At a glance

  • Drugs Empagliflozin (Primary) ; Insulin detemir; Insulin glargine; Insulin suspension isophane
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • 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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