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: 02 Jul 2018

At a glance

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

    • 02 Jul 2018 According to a Boehringer Ingelheim media release, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to update the labels of Jardiance (empagliflozin), Synjardy (empagliflozin and metformin) and Glyxambi (empagliflozin and linagliptin) to include additional important data from this study.
    • 26 Jun 2018 Results presented at the 78th Annual Scientific Sessions of the American Diabetes Association
    • 26 Jun 2018 Results assessing Mortality and Hospitalization for Heart Failure by Cardiovascular Risk Score at Baseline, presented at the 78th Annual Scientific Sessions of the American Diabetes Association
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