临床试验

达格列净、格列美脲与二甲双胍固定剂量复方片治疗 2 型糖尿病的疗效与安全性:III 期试验

来源:Advances in therapy · PMID 42970163 · DOI 10.1007/s12325-026-03791-1 · 来源:IMA 知识库《文献层·文献监控卡片》2026-11-05 期 · 全文级(file_id dAlZBwueyWSz,实际下载核验 1,395,640 B) · 全文已获取并通过三重归属校验

时间标签:数据日期 2026-11-05 · 生成时间 2026-11-05 05:30(Asia/Shanghai)| 检索窗口 PubMed edat 2026/11/02 – 2026/11/06 | 情报发生日期 2026-11-05

研究问题

(原文未给出可直接抽取的对应表述)

方法

Despite metformin being the first-line therapy, many patients require combination treatment due to the progressive and multifactorial nature of T2DM.;This study has evaluated efficacy and safety of FDC of dapagliflozin (DAPA), glimepiride (GLIM), and metformin (MET) immediate release (IR) tablet versus co-administration of GLIM and MET tablets in patients with T2DM.;Methods: This phase 3, randomized, open-label study included 536 Indian patients with T2DM [glycated hemoglobin (HbA1c) ≥ 8.0% and P.

核心结论

Conclusions: The FDC of DAPA + GLIM + MET IR tablet demonstrated superior glycemic control over co-administration of glimepiride and metformin and acceptable safety profile, making it an effective therapeutic option for T2DM management.;The FDC demonstrated significantly greater HbA1c reduction and a higher proportion of patients achieving target glycemic control, with comparable tolerability to co-administered therapy.;These findings support the use of FDC as an effective therapeutic option for T2DM, potentially simplifying treatment regimens and improving patient outcomes in clinical practice.

局限

However, adherence declines as the number of medications increases [33, 34].

对本项目的价值

中等价值:属「代谢 / 内分泌 / 肝肾老化」方向;代谢 / 内分泌 / 肝肾老化的界面栏目可用作本项目文献库与综述素材。 | 价值分 2.6/5(★★★☆☆)

全文来源

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原文题录

  • 中文题名:达格列净、格列美脲与二甲双胍固定剂量复方片治疗 2 型糖尿病的疗效与安全性:III 期试验
  • 英文标题:Efficacy and Safety of Dapagliflozin, Glimepiride, and Metformin Fixed-Dose Combination Tablet in Type 2 Diabetes: A Phase III Trial.
  • 期刊与标识:Advances in therapy · PMID 42970163 · DOI 10.1007/s12325-026-03791-1

A 级证据分级:A 级(同行评议人体研究)

本文属人体研究证据,但需注意:观察性或小样本干预的结论不等于已证实临床获益;效应量与长期安全性仍需更大规模、更长随访的试验验证。

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