AstraZeneca announced top-line results of its phase III DECLARE-TIMI 58 cardiovascular outcomes trial for dapagliflozin (Farxiga). The 5-year international trial evaluated the cardiovascular outcomes of dapagliflozin compared with placebo in more than 17,000 adults with type 2 diabetes at high cardiovascular risk or established disease.
DECLARE met its primary safety endpoint of noninferiority for major adverse cardiovascular events for dabigatran the company said . Specifically, it achieved a statistically significant reduction in the composite endpoint of hospitalization for heart failure or cardiovascular death.
Dapagliflozin, approved in 2014, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Full results of DECLARE will be presented on November 10 at the American Heart Association annual meeting, according to the AstraZeneca release.