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

Study · id `cardio:empa-reg-outcome` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

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Also called: EMPA-REG OUTCOME

Browse, organ or system: Heart; Metabolism  
Browse, condition area: Diabetes and metabolic disease  

## In plain language

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.

## 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.

## Key facts

- 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: 7064 participants (enrolled count; BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME)., snapshot `cardio:ctgov-nct01131676-2026-10-14`, retrieved 2026-10-14); 7020 patients (treated count; Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes, snapshot `cardio:pubmed-26378978-2026-10-14`, retrieved 2026-10-14)
- Started: 2010-07 (BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME)., snapshot `cardio:ctgov-nct01131676-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2015-04 (actual) (BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME)., snapshot `cardio:ctgov-nct01131676-2026-10-14`, retrieved 2026-10-14)
- Completion: 2015-04 (actual) (BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME)., snapshot `cardio:ctgov-nct01131676-2026-10-14`, retrieved 2026-10-14)
- 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)., snapshot `cardio:ctgov-nct01131676-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct01131676-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Lists type 2 diabetes as its condition: Type 2 diabetes (`cardio:type-2-diabetes`)
- Lead sponsor on the registry record: Boehringer Ingelheim (`cardio:boehringer-ingelheim`)
- Collaborator on the registry record: Eli Lilly and Company (`cardio:eli-lilly`)
- Tests this medicine (the registry title names empagliflozin): Empagliflozin (`cardio:empagliflozin`)

## Provenance

Content hash: 8ecbb697807595b67bf45d90ecd23aade9d9cd8e09261d742071de56a50e77ee
Last substantive edit: 2026-10-14
Evidence last checked: Not recorded