Study design

DEVOTE6

Population: Adult patients with T2D and ASCVD.

Study design: Treat-to-target, randomized, double-blind, active comparator-controlled, event-driven cardiovascular outcomes trial assessing the noninferiority of once-daily Tresiba® U-100 (n=3818) and once-daily insulin glargine U-100 (n=3819) in terms of the incidence of cardiovascular events.

Primary composite endpoint: Time from randomization to first occurrence of an adjudicated major adverse cardiovascular event (MACE): cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

Secondary confirmatory endpoints: The number and incidence of adjudicated events of severeh hypoglycemia, as defined in 2013 by the American Diabetes Association.

hSevere hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions and during which plasma glucose concentration may not have been available, but where neurological recovery following the return of plasma glucose to normal was considered sufficient evidence that the event was induced by a low plasma glucose concentration.

ASCVD=atherosclerotic cardiovascular disease; MACE=cardiovascular death, nonfatal MI, or nonfatal stroke.