Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Science, Beijing, China.
National School of Development, Peking University, Beijing, China.
Front Endocrinol (Lausanne). 2021 Sep 30;12:712200. doi: 10.3389/fendo.2021.712200. eCollection 2021.
This study investigated the clinical efficacy and safety of metformin hydrochloride sustained-release (SR) tablet (II) produced by Dulening and the original metformin hydrochloride tablet produced by Glucophage in the treatment of type 2 diabetes mellitus (T2DM).
This randomized, open and parallel controlled clinical trial consecutively recruited a total of 886 patients with T2DM in 40 clinical centers between May 2016 and December 2018. These patients were randomly assigned to the Dulening group (n=446), in which patients were treated with Dulening metformin SR tablets, and the Glucophage group (n=440), in which patients were treated with Glucophage metformin tablets, for 16 weeks. The changes in the levels of glycated hemoglobin (HbAc1) and fasting blood glucose (FBG) as well as weight loss were compared between these two groups. Also, the overall incidence of adverse drug reactions (ADRs) and the incidence of ADR of the gastrointestinal system observed in patients of these two groups were also compared.
There were no significant differences in demographic and basal clinical characteristics between these two groups. The Dulening and Glucophage groups showed comparable levels of decrease in HbA1c levels, FBG and weight loss after 12-week treatment (all p>0.05). The Dulening group had a significantly lower overall incidence of ADRs as well as gastrointestinal ADR than the Glucophage group.
Metformin SR tablets (II) and the original metformin tablets exhibit similar therapeutic efficacy in the treatment of T2DM, but metformin SR tablets (II) has the significantly lower incidence of ADRs than the original metformin tablets.
本研究旨在考察都乐宁盐酸二甲双胍缓释（Ⅱ）片与原研药格华止盐酸二甲双胍片治疗 2 型糖尿病（T2DM）的临床疗效和安全性。
本研究采用随机、开放、平行对照的临床试验方法，于 2016 年 5 月至 2018 年 12 月连续入组 886 例 T2DM 患者，按 1∶1 比例随机分配至都乐宁组（n=446）和格华止组（n=440），分别给予都乐宁盐酸二甲双胍缓释（Ⅱ）片和格华止盐酸二甲双胍片治疗，疗程均为 16 周。比较两组患者治疗前后糖化血红蛋白（HbA1c）、空腹血糖（FBG）及体质量的变化，同时比较两组患者药物不良反应（ADR）的总发生率及胃肠道 ADR 的发生率。
两组患者的一般人口学特征及基线临床资料比较差异无统计学意义。治疗 12 周后，两组患者的 HbA1c、FBG 及体质量较治疗前均明显下降（均 P>0.05），但两组间比较差异均无统计学意义。都乐宁组 ADR 的总发生率及胃肠道 ADR 的发生率均明显低于格华止组。
都乐宁盐酸二甲双胍缓释（Ⅱ）片与原研药格华止盐酸二甲双胍片治疗 T2DM 的疗效相当，但都乐宁盐酸二甲双胍缓释（Ⅱ）片的 ADR 发生率明显低于格华止盐酸二甲双胍片。
