Guo Li-Xin, Wang Lian-Wei, Tian De-Zeng, Xu Feng-Mei, Huang Wei, Wu Xiao-Hong, Zhu Wei, Chen Jun-Qiu, Zheng Xin, Zhou Hai-Yan, Li Hong-Mei, He Zhong-Chen, Wang Wen-Bo, Ma Li-Zhen, Duan Jun-Ting
Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Department of Endocrinology, Zhumadian Central Hospital, Henan, China.
Diabetes Ther. 2024 Nov;15(11):2351-2366. doi: 10.1007/s13300-024-01638-y. Epub 2024 Sep 16.
We aim to evaluate the efficacy and safety of pioglitazone/metformin fixed-dose combination (FDC) versus uptitrated metformin in patients with type 2 diabetes mellitus (T2DM) without adequate glycemic control.
A total of 304 patients were recruited from 15 hospitals in China and randomly assigned (1:1) to the test group (pioglitazone/metformin FDC, 15/500 mg) or the control group (uptitrated metformin, 2000-2500 mg/day). The primary endpoint was the proportion of patients with glycated hemoglobin A1c (HbA1c) ≤ 6.5% and ≤ 7.0% at week 16. The secondary outcomes included the change from baseline in glucose, serum lipids, and liver function. Full analysis set (FAS) and per-protocol set (PPS) were used for analyses.
In the test group, 103 (69.59%) patients reached HbA1c ≤ 7.0% (FAS, P = 0.009), with 68 (45.95%) patients achieved HbA1c ≤ 6.5 (FAS, P = 0.043). More reduction in HbA1c, homeostatic model assessment for insulin resistance, and diastolic pressure was found. Bodyweight, body mass index, and high-density lipoprotein cholesterol increased markedly. The changes of triglycerides, alanine transaminase, aspartate aminotransferase, and high-sensitivity C-reactive protein decreased noticeably. There were no significant differences in rates of adverse events between the two groups.
Pioglitazone/metformin FDC was superior to uptitrated metformin among patients with T2DM without adequate glycemic control.
This trial is registered with the Chinese Clinical Trial Registry (ChiCTR1900028606).
我们旨在评估吡格列酮/二甲双胍固定剂量复方制剂（FDC）与递增剂量二甲双胍相比，对血糖控制不佳的2型糖尿病（T2DM）患者的疗效和安全性。
从中国15家医院招募了304例患者，并随机（1:1）分配至试验组（吡格列酮/二甲双胍FDC，15/500毫克）或对照组（递增剂量二甲双胍，2000 - 2500毫克/天）。主要终点是第16周时糖化血红蛋白A1c（HbA1c）≤6.5%和≤7.0%的患者比例。次要结局包括血糖、血脂和肝功能相对于基线的变化。采用全分析集（FAS）和符合方案集（PPS）进行分析。
在试验组中，103例（69.59%）患者达到HbA1c≤7.0%（FAS，P = 0.009），68例（45.95%）患者达到HbA1c≤6.5（FAS，P = 0.043）。发现HbA1c、胰岛素抵抗稳态模型评估和舒张压有更多降低。体重、体重指数和高密度脂蛋白胆固醇显著增加。甘油三酯、丙氨酸转氨酶、天冬氨酸转氨酶和高敏C反应蛋白的变化明显减少。两组不良事件发生率无显著差异。
在血糖控制不佳的T2DM患者中，吡格列酮/二甲双胍FDC优于递增剂量二甲双胍。
本试验已在中国临床试验注册中心注册（ChiCTR1900028606）。
