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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
Author(s) -
Yang Wenying,
Xu Xiangjin,
Lei Tao,
Ma Jianhua,
Li Ling,
Shen Jie,
Ye Binqi,
Zhu Sandy,
Meinicke Thomas
Publication year - 2021
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.14231
Subject(s) - linagliptin , medicine , placebo , metformin , postprandial , clinical endpoint , insulin , randomized controlled trial , diabetes mellitus , adverse effect , type 2 diabetes mellitus , type 2 diabetes , gastroenterology , endocrinology , alternative medicine , pathology
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.