Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36‐week, randomized, double‐blind, parallel‐group trial

摘要

Aims/Introduction To assess efficacy and safety of liraglutide in combination with insulin compared with insulin monotherapy in Japanese patients with type 2 diabetes. Materials and methods This was a 36-week, multicenter, double-blind, parallel-group trial, where patients on stable insulin therapy (basal/premixed/basal–bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day ( n = 127) or placebo ( n = 130). The insulin dose was fixed for 16 weeks, and titrated based on self-measured plasma glucose thereafter. The primary end-point was change in glycosylated hemoglobin after 16 weeks. Results Superiority of liraglutide plus insulin versus insulin monotherapy was confirmed based on estimated mean difference in glycosylated hemoglobin after 16 weeks of ?1.30% (?14 mmol/mol; 95% confidence interval ?1.47 to ?1.13 [?16, ?12]; P Conclusions Adding liraglutide to insulin results in superior glycemic control compared with insulin alone in Japanese patients with type 2 diabetes, and is generally well tolerated.