Population: Adults with T1D.1
Patients randomized: Tresiba® (n=472); insulin glargine U-100 (n=157).1
Study design: 52-week, randomized, controlled, open-label, multinational, parallel-design, treat-to-target, noninferiority trial comparing the efficacy and safety of once-daily Tresiba® and once-daily insulin glargine U-100. Insulin aspart was administered before each meal in both treatment arms.
Basal insulin was titrated once weekly to an FPG target of 70 mg/dL to 90 mg/dL according to mean prebreakfast self-measured plasma glucose (SMPG) values (mean of 3 consecutive days). Bolus insulin was titrated to preprandial and bedtime SMPG concentrations of 70 mg/dL to 90 mg/dL.1,2
Primary endpoint: Change in A1C from baseline after 52 weeks of treatment.2
Secondary endpoints: FPG, SMPG, health-related quality of life, hypoglycemia, body weight, and lipids. Other safety endpoints were assessed in participants exposed to treatment.2
Mean end-of-trial basal and bolus insulin doses: Tresiba® arm: Tresiba®, 29 units; insulin aspart, 32 units; insulin glargine U-100 arm: insulin glargine U-100, 31 units; insulin aspart, 35 units.1