Effect of Linagliptin on Glycemic Control in Chinese Patients with Newly-Diagnosed, Drug-Naïve Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Wenjun Wu, Ying Li, Xiong Chen, Dini Lin, Songying Xiang, Feixia Shen, Xuemei Gu
Department of Endocrinology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China (mainland)
Med Sci Monit 2015; 21:2678-2684
This study aimed to evaluate the efficacy and safety of linagliptin (a novel dipeptidyl peptidase (DPP)-4 inhibitor) on glucose metabolism and β-cell function in Chinese patients with newly-diagnosed, drug-naïve type 2 diabetes mellitus (T2DM).
MATERIAL AND METHODS: Newly-diagnosed and drug-naïve T2DM patients were enrolled. After 4-week lifestyle modulation and 2-week placebo run-in, 57 patients were randomized to double-blind treatment with linagliptin (n=34) or placebo (n=23). The primary endpoint was the change from baseline in glycosylated hemoglobin A1c (HbA1c) after 24 weeks. Fasting plasma glucose (FPG), 2-h postprandial plasma glucose (2h-PPG), fasting insulin, proinsulin-to-insulin ratio, homeostasis model assessment of insulin resistance (HOMA-IR), and homeostasis model assessment of β-cell function (HOMA-β) were also evaluated.
RESULTS: Baseline characteristics were similar between the 2 groups. Compared with placebo, linagliptin therapy resulted in a significant decrease in HbA1C (–1.2±0.7% vs. –0.4±0.4%, P<0.001), FBG (–0.98±1.17 vs. –0.32±0.51 mmol/L, P=0.011, and 2h-PPG (–2.02±0.94 vs. –0.97±0.63 mmol/L, P<0.001). Significant differences were observed for the proinsulin/insulin ratio (P<0.001) and HOMA-β index (P=0.001). Rates of adverse events were similar between the 2 groups (30.3% vs. 27.3%). All adverse events were mild. One patient discontinued participation due to pregnancy.
CONCLUSIONS: Linagliptin treatment resulted in a significant and clinically meaningful improvement of glycemic control in drug-naïve Chinese patients with T2DM, as well as improved parameters of b-cell function. Linagliptin had an excellent safety profile.
Keywords: Blood Glucose - analysis, Adult, Blood Pressure, Body Mass Index, Diabetes Mellitus, Type 2 - drug therapy, Dipeptidyl-Peptidase IV Inhibitors - therapeutic use, Double-Blind Method, Hemoglobin A, Glycosylated - metabolism, Homeostasis, Hyperglycemia - drug therapy, Hypoglycemic Agents - therapeutic use, Insulin Resistance, Insulin-Secreting Cells - metabolism, Life Style, Linagliptin - therapeutic use, Postprandial Period, Time Factors