# DECLARE-TIMI 58: dapagliflozin and cardiovascular outcomes in type 2 diabetes

Study · id `cardio:declare-timi-58` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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Also called: DECLARE-TIMI 58; DECLARE-TIMI58

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 who had heart or blood-vessel disease or were at risk of it. They took dapagliflozin 10 mg a day or placebo. Dapagliflozin did not lower the rate of the main combined outcome of heart attack, stroke and heart-related death. It did lower the combined outcome of heart-related death or hospital stays for heart failure, because of fewer heart-failure stays. Ketoacidosis and genital infections were more common on dapagliflozin.

## Technical summary

Randomized, double-blind, placebo-controlled trial sponsored by AstraZeneca (NCT01730534). 17,160 patients were evaluated (10,186 without atherosclerotic cardiovascular disease), median follow-up 4.2 years; the registry counts 17190 enrolled. Noninferiority for major adverse cardiovascular events was met (upper boundary of the 95% CI below 1.3). Major adverse cardiovascular events: 8.8% against 9.4%, hazard ratio 0.93 (95% CI 0.84 to 1.03; P=0.17). Cardiovascular death or hospitalization for heart failure: 4.9% against 5.8%, hazard ratio 0.83 (0.73 to 0.95).

## Key facts

- Design: Multicenter, randomized, double-blind, placebo-controlled trial with parallel groups. The registry records phase 3 and quadruple masking.
- Phase: Phase 3
- Enrolled: 17190 participants (enrolled count; Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events, snapshot `cardio:ctgov-nct01730534-2026-10-14`, retrieved 2026-10-14)
- Started: 2013-04-25 (actual) (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events, snapshot `cardio:ctgov-nct01730534-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2018-09-11 (actual) (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events, snapshot `cardio:ctgov-nct01730534-2026-10-14`, retrieved 2026-10-14)
- Completion: 2018-09-11 (actual) (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events, snapshot `cardio:ctgov-nct01730534-2026-10-14`, retrieved 2026-10-14)
- Results first posted: 2019-12-26 (actual) (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events, snapshot `cardio:ctgov-nct01730534-2026-10-14`, retrieved 2026-10-14)
- Countries: United States; Argentina; Australia; Belgium; Brazil; Bulgaria; Canada; China; Czechia; France; Germany; Hungary; India; Israel; Italy; Japan; Mexico; Netherlands; Philippines; Poland; Romania; Russia; Slovakia; South Africa; South Korea; Spain; Sweden; Taiwan; Thailand; Ukraine; United Kingdom; Vietnam; Türkiye; Hong Kong SAR China (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events, snapshot `cardio:ctgov-nct01730534-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct01730534-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Enrolled people with type 2 diabetes: Type 2 diabetes (`cardio:type-2-diabetes`)
- Lead sponsor on the registry record: AstraZeneca (`cardio:astrazeneca`)
- Tests this medicine: Dapagliflozin (`cardio:dapagliflozin`)

## Provenance

Content hash: 713a02a44c248cec5cc8a3bc5ff5a6c443dd79352475170ccd680cb1db78dfff
Last substantive edit: 2026-10-14
Evidence last checked: Not recorded