Cardiovascular safety of insulin degludec versus insulin glargine in patients at high risk of cardiovascular events: Design of the DEVOTE Cardiovascular Outcomes Trial (DEVOTE 1)

Publication date: Available online 18 June 2016 Source:American Heart Journal Author(s): Steven P. Marso, Darren K. McGuire, Bernard Zinman, Neil R. Poulter, Scott S. Emerson, Thomas R. Pieber, Richard E. Pratley, Poul-Martin Haahr, Martin Lange, Kirstine Brown Frandsen, Rasmus Rabøl, John B. Buse The Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) was designed to evaluate the cardiovascular safety of insulin degludec versus insulin glargine U100 in patients with type 2 diabetes at high risk of cardiovascular events. DEVOTE is a phase 3b, multicenter, international, randomized, double-blind, active comparator-controlled trial, designed as an event-driven trial that would continue until 633 positively adjudicated primary events were accrued. 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. Patients with type 2 diabetes at high risk of cardiovascular complications were randomized 1:1 to receive either insulin degludec or insulin glargine, each added to background therapies. This trial was designed to demonstrate statistical non-inferiority of insulin degludec versus insulin glargine for the primary endpoint. DEVOTE enrolled 7637 patients between October 2013 and November 2014 at 436 sites in 20 countr...
Source: American Heart Journal - Category: Cardiology Source Type: research