Efficacy and safety of linagliptin as add-on therapy to insulin in Chinese patients with type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled trial.

This 24-week, double-blind, placebo-controlled, phase III trial evaluated the efficacy and safety of linagliptin in 206 Chinese patients with inadequately controlled (glycated hemoglobin [HbA1c] 7.5-10.0%) type 2 diabetes mellitus (T2DM) receiving insulin (basal or premixed) ± metformin. Patients were randomized (1:1) to receive linagliptin 5 mg/day or placebo. The decrease from baseline in HbA1c (primary endpoint) was greater with linagliptin than placebo (-0.61% versus -0.20%; adjusted mean difference, -0.40%; P = 0.0016). Linagliptin demonstrated significantly greater improvement in 2-hour postprandial glucose (-31.95 mg/dL; P <0.001), and a numerical reduction in fasting plasma glucose (-6.2 mg/dL; P = 0.2241) versus placebo. Proportionally more patients on linagliptin achieved HbA1c ≥0.5% reduction versus placebo (odds ratio, 2.293; P <0.01). Adverse events in both groups were similar, with no new safety findings or clinically relevant changes in body weight. Among investigator-defined hypoglycemic events (linagliptin, 17.3%; placebo, 12.7%; odds ratio, 1.48; P = 0.337), none were severe. In Chinese patients with T2DM, linagliptin add-on to insulin improves glycemic control and is well tolerated, without increased risk for hypoglycemia or weight gain. This article is protected by copyright. All rights reserved.