SAVOR-TIMI 53 SAVOR-TIMI 53, a multicenter, randomized, double-blind, placebo-controlled Phase 4 trial conducted at 788 sites in 26 countries, included patients with type 2 diabetes mellitus, HbA1c levels between 6.5% and 12.0%, and either established or multiple risk factors for cardiovascular disease. A total of 16,492 patients were randomized to receive either saxagliptin 5 mg daily (or 2.5 mg daily in patients with renal impairment) or matching placebo over a median follow-up of 2.1 years.
Treatment with all other diabetes and cardiovascular medications was left to the discretion of the treating physician. The primary endpoint of the study, a composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal ischemic stroke occurred in 7.3% of the saxagliptin group compared with 7.2% of the placebo group (hazard ratio [HR] 1.00; P =0.99 for superiority and P <0.001 for…
