liraglutide vs PEX168

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.

NCT02477969 · Phase 3 · status unknown

This was a randomized, triple-blind, placebo-controlled trial with 587 participants, testing PEX168 against placebo, both added to metformin, using change in HbA1c as the primary measure. A published report of the trial's results describes the primary endpoint as met, with substantially more PEX168 patients than placebo patients reaching HbA1c targets at 24 weeks.