IcoSema vs liraglutide

NCT05352815 · Phase 3 · completed

Participants were randomized 1:1 to IcoSema or active insulin icodec, but the study was open-label rather than blinded. The primary HbA1c endpoint was statistically significantly better with IcoSema, although HbA1c is a surrogate metabolic measure rather than a hard clinical endpoint.

NCT00318461 · Phase 3 · completed

This was a large (n=1091), randomized, double-blind, parallel-group trial with both a placebo-controlled comparison (liraglutide + metformin vs metformin + liraglutide placebo) and an active-controlled comparison (glimepiride + metformin). The primary endpoint was change in HbA1c at week 26, a hard, regulator-accepted outcome for type 2 diabetes. The prespecified primary comparisons for liraglutide 1.2 mg and 1.8 mg/day were met: both were significantly superior to metformin alone (p<0.0001) and non-inferior to glimepiride + metformin within the 0.4% margin. The 0.6 mg dose was superior to metformin but did not meet non-inferiority against glimepiride + metformin, which does not negate the positive results for the clinically relevant doses.