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. Issue 2 (6th November 2020)

• Record Type: Journal Article
• Authors: Yang, Wenying; Xu, Xiangjin; Lei, Tao; Ma, Jianhua; Li, Ling; Shen, Jie; Ye, Binqi; Zhu, Sandy; Meinicke, Thomas
• Is Part Of: Diabetes, obesity & metabolism. Volume 23:Issue 2(2021)
• Page Start: 642
• Page End: 647
• Publication Date: 2020-11-06
• Subjects: glycaemic control -- insulin therapy -- linagliptin -- phase III study -- randomized trial -- type 2 diabetes; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.14231
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract: 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 haemoglobin [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/d or placebo. The decrease from baseline in HbA1c (primary endpoint) was greater with linagliptin than with placebo (−0.61% vs. −0.20%, adjusted mean difference −0.40%; P = 0.0016). Linagliptin demonstrated significantly greater improvement in 2‐hour postprandial glucose (−1.77 mmol/L [−31.95 mg/dL]; P < 0.001), and a numerical reduction in fasting plasma glucose (−0.34 mmol/L [−6.2 mg/dL]; P = 0.2241) versus placebo. Proportionally more patients on linagliptin achieved a HbA1c reduction of ≥0.5% versus those on 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 hypoglycaemic 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 improved glycaemic control and was well tolerated, without increased risk of hypoglycaemia or weight gain.