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

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.

Also called DECLARE-TIMI 58 · DECLARE-TIMI58

  • Study
  • In this atlas

Overview

Design
Multicenter, randomized, double-blind, placebo-controlled trial with parallel groups. The registry records phase 3 and quadruple masking.
Phase
Phase 3
Enrolled
  • 17,190 participants (enrolled count) (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT01730534
Started
(actual) (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events, retrieved )
Primary completion
(actual) (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events, retrieved )
Completion
(actual) (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events, retrieved )
Results first posted
(actual) (Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events, retrieved )
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, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

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).

Arms

  • Dapagliflozin

    Intervention None named

    Dapagliflozin 10 mg once daily.

  • Placebo

    Intervention None named

    Placebo tablet.

Findings

No findings are published for this study.

Record details

Record id
cardio:declare-timi-58
Content hash
713a02a44c248cec5cc8a3bc5ff5a6c443dd79352475170ccd680cb1db78dfff