Population: Adults with type 1 diabetes.
Study design: Randomized, double-blind, parallel-group, single-center trial evaluating the within-subject, day-to-day variability and glucose-lowering effect of Tresiba® U-100 (n=27) vs insulin glargine U-100 (n=27) under steady-state conditions. Patients received Tresiba® U-100 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 PD response between Tresiba® U-100 and insulin glargine U-100 based on the area under the glucose infusion rate curve (AUCGIR) during 1 dosing interval (0-24 hours) at steady state. The within-subject, day-to-day PD variability in glucose-lowering effect in the Tresiba® arm was 20% and in the insulin glargine U-100 arm was 82% at steady state.
Secondary PD endpoints: To investigate whether within-subject variability was consistent over 24 hours, the within-subject of AUCGIR in 2-hour intervals (AUCGIR,0-2h,SS’ AUCGIR,2-4h,SS’ AUCGIR,4-6h,SS’ AUCGIR,20-22h,SS’ AUCGIR,22-24h,SS) was analyzed in a post-hoc analysis.