LEADER study design1
A phase 3b, multicenter, international, randomized, double-blind, placebo-controlled study to assess the cardiovascular safety of Victoza®. Adult patients with type 2 diabetes at high risk for cardiovascular events (N=9340) were randomized to receive once-daily Victoza® (0.6 mg-1.8 mg once daily with all patients being titrated to 1.8 mg once daily) or placebo. The primary endpoint was the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. The trial was prospectively designed and powered to assess whether Victoza® was noninferior or superior to placebo when measuring effect on CV events. Patients received trial products in addition to standard of care treatments such as oral antidiabetic treatments, insulin, and antihypertensive, antiplatelet, and lipid-lowering therapies.