吡格列酮/二甲双胍固定剂量复方制剂与优降糖二甲双胍对血糖控制不佳的 2 型糖尿病患者的疗效和安全性对比：随机临床试验

IF 3.8 3区医学 Q2 Medicine Diabetes Therapy Pub Date : 2024-09-16 DOI:10.1007/s13300-024-01638-y

Li-xin Guo, Lian-wei Wang, De-zeng Tian, Feng-mei Xu, Wei Huang, Xiao-hong Wu, Wei Zhu, Jun-Qiu Chen, Xin Zheng, Hai-Yan Zhou, Hong-Mei Li, Zhong-Chen He, Wen-Bo Wang, Li-Zhen Ma, Jun-Ting Duan

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引用次数: 0

摘要

方法从中国15家医院招募304名患者，随机分配（1:1）至试验组（吡格列酮/二甲双胍固定剂量复方制剂，15/500 mg）或对照组（二甲双胍升糖剂，2000-2500 mg/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。次要结果包括血糖、血脂和肝功能与基线相比的变化。结果在试验组中，103 例（69.59%）患者的 HbA1c ≤ 7.0%（FAS，P = 0.009），68 例（45.95%）患者的 HbA1c ≤ 6.5（FAS，P = 0.043）。HbA1c、胰岛素抵抗稳态模型评估和舒张压的降低幅度更大。体重、体重指数和高密度脂蛋白胆固醇明显增加。甘油三酯、丙氨酸转氨酶、天门冬氨酸氨基转移酶和高敏 C 反应蛋白的变化明显下降。结论在血糖控制不佳的T2DM患者中，吡格列酮/二甲双胍FDC优于升糖二甲双胍。

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Efficacy and Safety of Pioglitazone/Metformin Fixed-Dose Combination Versus Uptitrated Metformin in Patients with Type 2 Diabetes without Adequate Glycemic Control: A Randomized Clinical Trial

Introduction

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.

Methods

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.

Results

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.

Conclusions

Pioglitazone/metformin FDC was superior to uptitrated metformin among patients with T2DM without adequate glycemic control.

Trial Registration Number

This trial is registered with the Chinese Clinical Trial Registry (ChiCTR1900028606).

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来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.