Study design


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 severef hypoglycemia, as defined in 2013 by the American Diabetes Association.

fSevere 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. 

EXPECT Trial1,6

Population: Adult pregnant females with type 1 diabetes.

Patients randomized: Tresiba® (once daily) or insulin detemir (once or twice daily); both groups received insulin aspart 2 to 4 times daily with meals.

Study design: The EXPECT study is an open-label, randomized trial of 185 pregnant women aged ≥18 years with type 1 diabetes and who were previously treated with insulin and were at 8-13 weeks' gestation or planned to become pregnant within 52 weeks. Poor glucose control during pregnancy in both groups and small sample size were limitations of the study.

Primary endpoint: The primary analysis aimed to demonstrate the noninferiority (margin of 0.4%) of Tresiba® to insulin detemir with respect to the last planned glycated hemoglobin (HbA1c) measurement prior to delivery (>16 weeks’ gestation) using ANCOVA.

Secondary endpoints: Secondary endpoints were pregnancy outcomes as well as maternal efficacy and safety outcomes.

ANCOVA=analysis of covariance.