Efficacy and safety of adding liraglutide to existing insulin regimens in Japanese patients with type 2 diabetes mellitus: A post-hoc analysis of a phase 3 randomized clinical trial.

AIMS/INTRODUCTION: To determine the efficacy and safety of adding liraglutide to three different insulin regimens in Japanese patients with type 2 diabetes mellitus. MATERIALS AND METHODS: In this post-hoc analysis, results from a 36-week, randomized, double-blind, placebo-controlled, parallel-group trial are reported. Individuals with type 2 diabetes mellitus were stratified according to their pre-trial insulin regimen (basal, basal-bolus and premix). The primary objective was to determine whether adding liraglutide (0.9 mg/day) to fixed-dose insulin therapy was superior vs fixed-dose insulin monotherapy, assessed by the effect on glycemic control after 16 weeks of treatment. RESULTS: The treatment effect on glycated hemoglobin reduction was independent of the pre-trial insulin regimen. Comparing liraglutide with a placebo, liraglutide was associated with glycated hemoglobin reduction in all insulin regimens, with placebo-corrected reductions at 16 weeks ranging from -1.45 to -1.17%, and maintained at 36 weeks. Liraglutide resulted in a greater reduction in mean plasma glucose obtained from seven-point self-monitoring, and greater proportions of patients achieved target glycated hemoglobin. With liraglutide, slightly higher proportions of patients receiving basal and basal-bolus insulin reported confirmed hypoglycemia from 0 to 16 weeks. CONCLUSIONS: The efficacy and safety of adding liraglutide to insulin therapy was confirmed, regardless of pre-trial insulin regimen.