A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

Trial Profile

A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2017

At a glance

  • Drugs Empagliflozin (Primary)
  • Indications Cardiovascular disorders; Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EMPA-REG OUTCOME
  • Sponsors Boehringer Ingelheim Pharmaceuticals; Unilfarma
  • Most Recent Events

    • 08 Dec 2017 Results assessing CV outcomes and all-cause mortality by smoking status at baseline, presented at the 2017 Congress of the International Diabetes Federation
    • 04 Dec 2017 Results of a post-hoc analysis assessing the effects of potential mediators on CV death, published in the Diabetes Care
    • 15 Nov 2017 Results presented at the 90th Annual Scientific Sessions of the American Heart Association
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