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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Oct 2023

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At a glance

  • Drugs Empagliflozin (Primary)
  • Indications Cardiovascular disorders; Heart failure; Myocardial infarction; Stroke; Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EMPA-REG OUTCOME
  • Sponsors Boehringer Ingelheim Pharmaceuticals; Eli Lilly and Company; Unilfarma

Most Recent Events

  • 01 Sep 2023 Results of post-hoc analysis assessing the changes in haemodynamic markers as mediators of cardiovascular (CV) and kidney benefits with empagliflozin in patients with type 2 diabetes (T2D) and established CV disease receiving empagliflozin (10 and 25 mg) or placebo, published in the Journal of Diabetes and its Complications.
  • 23 Sep 2022 Results assessing the effectof the SGLT2 inhibitor empagliflozin (empa) on changes in CKD risk byassessing worsening and improvement in KDIGO risk group, presented at the 58th Annual Meeting of the European Association for the Study of Diabetes.
  • 01 Aug 2022 Results comparing individuals with diabetes from a nationally representative sample to patients who underwent randomization from this trial published in the Journal of General Internal Medicine

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