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

• Published in: Journal of diabetes investigation 2018-07, Vol.9 (4), p.840-849
• Main Authors: Kaneko, Shizuka, Nishijima, Keiji, Bosch‐Traberg, Heidrun, Kaku, Kohei, Seino, Yutaka
• Format: Article
• Language: English
• Subjects: Antidiabetics; Clinical trials; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Glucose; Glycated hemoglobin; Hemoglobin; Hypoglycemia; Insulin; Liraglutide; Original; Patients; Safety
• ISSN: 2040-1116; 2040-1124
• DOI: 10.1111/jdi.12793

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. Our post‐hoc analysis investigated the efficacy and safety of adding liraglutide to three different insulin regimens in Japanese patients. Our data suggest that Japanese patients on basal, basal–bolus and premix insulin may benefit from a greater improvement in glycemic control by combining their insulin with liraglutide, with only a slight increase in hypoglycemia risk from week 0 to 16.