Efficacy and Safety of Liraglutide vs Placebo Added to Basal Insulin Analogues (With or Without Metformin) in Patients With Type 2 Diabetes: A Randomized, Placebo-Controlled Trial

July, 2015

This 26-week, double-blind, parallel-group trial was conducted to confirm the superiority of adding liraglutide vs placebo to preexisting treatment with basal insulin plus metformin in patients with inadequately controlled type 2 diabetes (T2D). Patients (N=451) were randomized to liraglutide 1.8 mg once daily (with dose escalation over 2 weeks) or placebo. The primary endpoint was A1C reductions; post-randomization increases to patient insulin doses were not allowed. At 26 weeks, A1C levels were lower with liraglutide (-1.3%) than placebo (-0.1%; P<0.0001). Additionally, more patients on liraglutide achieved the A1C target <7.0% (59% vs 14% on placebo; P<0.0001). Adverse events were more frequent with liraglutide and included nausea (22.2% vs 3.1% for placebo) and minor hypoglycemia (18.2% vs 12.4%). Follow this link to read the study abstract.