Department of Endocrinology and Metabolism, Division of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
Department of Endocrinology and Metabolism, Division of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Diabetes Obes Metab. 2017 Dec;19(12):1681-1687. doi: 10.1111/dom.12987. Epub 2017 Jul 7.
To evaluate the efficacy and safety of evogliptin, a newly developed dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes (T2D) inadequately controlled by diet and exercise.
In this randomized, double-blind, placebo-controlled, parallel-group, multicentre, phase III study, 160 patients with T2D were assigned to either evogliptin 5 mg or placebo for 24 weeks. The primary endpoint was the mean change in glycated haemoglobin (HbA1c) from baseline to week 24.
The mean baseline HbA1c levels were similar in the evogliptin and the placebo groups (7.20% ± 0.56% vs 7.20% ± 0.63%, respectively). At week 24, evogliptin significantly reduced HbA1c levels from baseline compared with placebo (-0.23% vs 0.05%, respectively, P < .0001). Additionally, the proportion of patients achieving HbA1c <6.5% was significantly higher in the evogliptin group than in the placebo group (33.3% vs 15.2%; P = .008). The overall incidence of adverse events, including hypoglycaemia, was similar in the 2 groups.
In this 24-week study, once-daily evogliptin monotherapy significantly improved glycaemic control and was well tolerated in patients with T2D.
评估新型二肽基肽酶-4 抑制剂依格列净在饮食和运动控制不佳的 2 型糖尿病（T2D）患者中的疗效和安全性。
在这项随机、双盲、安慰剂对照、平行分组、多中心、III 期研究中，160 名 T2D 患者被分配接受依格列净 5mg 或安慰剂治疗 24 周。主要终点是从基线到 24 周时糖化血红蛋白（HbA1c）的平均变化。
依格列净组和安慰剂组的基线 HbA1c 水平相似（分别为 7.20%±0.56%和 7.20%±0.63%）。在 24 周时，与安慰剂相比，依格列净显著降低了 HbA1c 水平（分别为-0.23%和 0.05%，P<0.0001）。此外，与安慰剂组相比，依格列净组达到 HbA1c<6.5%的患者比例显著更高（33.3% vs 15.2%；P=0.008）。两组的不良事件总发生率，包括低血糖，相似。
在这项 24 周的研究中，依格列净单药治疗每天一次可显著改善血糖控制，且在 T2D 患者中具有良好的耐受性。
