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度拉糖肽治疗 2 型糖尿病的系统评价和随机 II/III 期临床试验荟萃分析。

Dorzagliatin for Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Phase II/III Trials.

机构信息

Department of Pharmacy, The First Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan, China; Clinical Medical College, Chengdu Medical College, Chengdu, Sichuan, China.

Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan, China; Clinical Medical College, Chengdu Medical College, Chengdu, Sichuan, China.

出版信息

Clin Ther. 2023 Dec;45(12):1277-1283. doi: 10.1016/j.clinthera.2023.09.011. Epub 2023 Sep 29.

Abstract

PURPOSE

Dorzagliatin is a glucokinase agonist with effects on type 2 diabetes mellitus (T2DM). This study included a meta-analysis on the efficacy and safety of dorzagliatin in the treatment of T2DM.

METHODS

The Cochrane Central Registry of Controlled Trials, PubMed, and Embase were searched from inception to July 25, 2022. A total of 3 studies including 1333 patients were identified in this meta-analysis.

FINDINGS

Overall, the meta-analysis showed that dorzagliatin remarkably reduced glycated hemoglobin levels versus placebo by 0.66%. The results of the meta-analysis showed a significant reduction in fasting plasma glucose of 6.77 mg/dL between dorzagliatin and placebo. In addition, dorzagliatin reduced 2-hour postprandial glucose (2h-PPG) by 43.87 mg/dL compared with placebo. Furthermore, the meta-analysis of available data revealed a significant reduction in the Homeostasis Model Assessment of Insulin Resistance of 0.07 between dorzagliatin and placebo. The risk of adverse events was slightly higher with dorzagliatin than with placebo.

IMPLICATIONS

Dorzagliatin significantly reduced glycated hemoglobin levels, fasting plasma glucose levels, 2h-PPG, and homeostasis model assessment 2 of insulin resistance in patients with T2DM. It was well tolerated and had good liver and kidney safety profiles.

摘要

目的

度拉糖肽是一种葡萄糖激酶激动剂,对 2 型糖尿病(T2DM)有作用。本研究对度拉糖肽治疗 T2DM 的疗效和安全性进行了荟萃分析。

方法

从建库到 2022 年 7 月 25 日,我们检索了 Cochrane 对照试验中心注册库、PubMed 和 Embase。本荟萃分析共纳入 3 项研究,共计 1333 例患者。

结果

总体而言,荟萃分析显示,与安慰剂相比,度拉糖肽显著降低糖化血红蛋白水平 0.66%。荟萃分析结果显示,度拉糖肽组空腹血糖较安慰剂组降低 6.77mg/dL。此外,与安慰剂相比,度拉糖肽组餐后 2 小时血糖降低 43.87mg/dL。此外,对现有数据的荟萃分析显示,度拉糖肽组与安慰剂组相比,胰岛素抵抗的稳态模型评估值降低了 0.07。度拉糖肽的不良反应风险略高于安慰剂。

结论

度拉糖肽可显著降低 T2DM 患者的糖化血红蛋白水平、空腹血糖水平、餐后 2 小时血糖水平和胰岛素抵抗的稳态模型评估 2 型,且具有良好的耐受性和肝脏、肾脏安全性。

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