efpeglenatide vs liraglutide

NCT03353350 · Phase 3 · completed

The trial was randomized, quadruple-blinded, placebo-controlled, and included 406 participants, providing a strong comparative design. However, the primary endpoint was the surrogate measure of HbA1c change, and although the reported changes favored efpeglenatide, statistical significance for the primary comparison was not reported.

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.