Cardiovascular Atlas
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EMPA-REG OUTCOME: empagliflozin and cardiovascular outcomes in type 2 diabetes

A large trial of people with type 2 diabetes at high risk of heart and blood-vessel disease. They took empagliflozin 10 mg or 25 mg a day, or placebo, on top of usual care. Empagliflozin lowered the chance of a combined heart event, and fewer people died from heart causes or from any cause. Heart attacks and strokes alone did not differ significantly. Genital infections were more common on empagliflozin.

Also called EMPA-REG OUTCOME

  • Study
  • In this atlas

Overview

Design
Multicenter, international, randomized, parallel-group, double-blind trial (registry official title). The registry records phase 3 and double masking. The registry names the study drug by a code (BI 10773).
Phase
Phase 3
Enrolled
  • 7,064 participants (enrolled count) (BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME)., retrieved )
  • 7,020 patients (treated count) (Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT01131676
Started
(BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME)., retrieved )
Primary completion
(actual) (BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME)., retrieved )
Completion
(actual) (BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME)., retrieved )
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, Denmark, Estonia, France, Georgia, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Taiwan, Thailand, Ukraine, United Kingdom, Hong Kong SAR China (BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME)., retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Randomized, double-blind trial sponsored by Boehringer Ingelheim with Eli Lilly as registry collaborator (NCT01131676). 7020 patients were treated, median observation 3.1 years. Primary outcome (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke), pooled empagliflozin against placebo: 490 of 4687 (10.5%) against 282 of 2333 (12.1%), hazard ratio 0.86 (95.02% CI 0.74 to 0.99; P=0.04 for superiority). The registry counts 7064 enrolled.

Arms

  • BI 10773 low dose

    Intervention None named

    Empagliflozin once daily at the lower dose; the abstract names the doses as 10 mg and 25 mg. The registry labels the study drug BI 10773.

  • BI 10773 high dose

    Intervention None named

    Empagliflozin once daily at the higher dose; the abstract names the doses as 10 mg and 25 mg. The registry labels the study drug BI 10773.

  • Placebo

    Intervention None named

    Placebo once daily.

Findings

No findings are published for this study.

Record details

Record id
cardio:empa-reg-outcome
Content hash
8ecbb697807595b67bf45d90ecd23aade9d9cd8e09261d742071de56a50e77ee