Population: Adults with type 1 diabetes.
Study design: Randomized, double-blind, parallel-group, single-center trial evaluating the day-to-day activity and glucose-lowering effect of Tresiba® 100 units/mL (n=27) vs insulin glargine U-100 (n=27) under steady-state conditions. Patients received Tresiba® or insulin glargine U-100 (0.4 units/kg) once daily for 12 days. The euglycemic clamp was performed on days 6, 9, and 12 of treatment and blood samples were taken throughout each clamp period.
Primary endpoint: To evaluate the within-subject variability of the pharmacodynamic response between Tresiba® and insulin glargine U-100 based on the area under the glucose infusion rate curve (AUCGIR) during one dosing interval (0-24 hours) at steady state.