DECLARE-TIMI 58

The trial, DECLARE-TIMI 58 (Dapagliflozin Effect on CardiovascuLAR Events) is a multi-national, randomized, double-blind, placebo-controlled Phase IIIB trial jointly led by the TIMI Study Group and Hadassah Medical Center, and sponsored by AstraZeneca and Bristol-Myers Squibb. DECLARE – TIMI 58 is a superiority trial and designed to test the hypothesis that in patients with type 2 diabetes mellitus long-term treatment with dapagliflozin, an oral sodium glucose cotransporter 2 (SGLT2) inhibitor, will reduce the incidence of the composite endpoint of cardiovascular death, myocardial infarction, or ischemic stroke. The trial will also seek to definitively exclude unacceptable cardiovascular risk from dapagliflozin in these patients. It is planned to randomize approximately 17,150 patients with type 2 diabetes mellitus and either known cardiovascular disease (secondary prevention cohort) or at least two risk factors for cardiovascular disease (primary prevention cohort). DECLARE-TIMI 58 is an event-driven trial, and we estimate that subjects will be followed for a median of 4.5

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