Zhang Fang, Tang Lizhi, Li Jing, Yan Zhe, Li Juan, Tong Nanwei
Division of Endocrinology and Metabolism, West China Hospital of Sichuan University, Chengdu, People's Republic of China.
Diabetes Metab Syndr Obes. 2021 Mar 18;14:1243-1252. doi: 10.2147/DMSO.S293307. eCollection 2021.
The prevalence of type 2 diabetes (T2D) has risen substantially in China, where its pathophysiology is primarily characterized by insulin resistance (IR). Alleviating IR may help with the management of T2D in the Chinese population. Pioglitazone and sitagliptin are two hypoglycemic medications with different pharmacological actions, both of which are optimal choices for use in combination with metformin. Previous studies have yielded mixed findings regarding the differences in hypoglycemic effects between the two agents. Though pioglitazone is associated with weight gain, both drugs have been shown to decrease visceral adipose tissue (VAT) and improve IR in individuals with T2D. There is a lack of direct comparisons between pioglitazone and sitagliptin among Chinese individuals with T2D. Therefore, this paper describes a protocol for a randomized controlled trial (RCT) that investigates the differences in hypoglycemic efficacy, IR improvement, and safety profiles between these drugs.
This is a 24-week, open-label, multicenter, non-inferiority parallel-group RCT with a 1:1 allocation ratio. It compares pioglitazone/metformin (15 mg/500 mg) combination therapy with sitagliptin/metformin (50 mg/500 mg) combination therapy in Chinese adults with T2D insufficiently controlled with metformin. The primary outcomes are HbA1c reduction, insulin level increase, and IR index change. The secondary outcomes are body weight and abdominal VAT decreases, lipid profiles, and inflammatory indicators. Tolerability and safety data will also be collected.
It is believed that the direct comparisons of the hypoglycemic effects, VAT reductions, and safety profiles between pioglitazone and sitagliptin will help to optimize treatments for Chinese adults with T2D who are primarily characterized by IR.
Chinese Clinical Trial Registry (ChiCTR1900021861).
2型糖尿病（T2D）在中国的患病率已大幅上升，其病理生理学主要特征为胰岛素抵抗（IR）。减轻IR可能有助于中国人群T2D的管理。吡格列酮和西格列汀是两种具有不同药理作用的降糖药物，二者均是与二甲双胍联合使用的最佳选择。先前的研究对于这两种药物降糖效果的差异得出了不一致的结果。尽管吡格列酮与体重增加有关，但这两种药物均已显示可减少2型糖尿病患者的内脏脂肪组织（VAT）并改善IR。在中国T2D患者中，吡格列酮和西格列汀之间缺乏直接比较。因此，本文描述了一项随机对照试验（RCT）方案，该试验旨在研究这些药物在降糖疗效、IR改善及安全性方面的差异。
这是一项为期24周的开放标签、多中心、非劣效性平行组RCT，分配比例为1:1。它比较吡格列酮/二甲双胍（15毫克/500毫克）联合治疗与西格列汀/二甲双胍（50毫克/500毫克）联合治疗对二甲双胍控制不佳的中国成年T2D患者的疗效。主要结局为糖化血红蛋白（HbA1c）降低、胰岛素水平升高和IR指数变化。次要结局为体重和腹部VAT减少、血脂谱和炎症指标。还将收集耐受性和安全性数据。
相信吡格列酮和西格列汀在降糖效果、VAT降低及安全性方面的直接比较将有助于优化以IR为主要特征的中国成年T2D患者的治疗。
中国临床试验注册中心（ChiCTR1900021861）。
