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达格列净、格列美脲和缓释二甲双胍片固定剂量复方制剂用于二甲双胍和格列美脲控制不佳的2型糖尿病患者：印度一项III期、开放标签、随机临床研究

Fixed dose combination of dapagliflozin, glimepiride and extended-release metformin tablets in patients with type 2 diabetes poorly controlled by metformin and glimepiride: A phase III, open label, randomized clinical study in India.

作者信息

Sahay Rakesh, Gangwani Dinesh, Singh Manish, Gupta Sandeep, Kale Narendra, Srivastava Manoj, Kurmi Prakash, Ambaliya Jayesh, Lomte Nilesh, Gofne Sandip, Agarwal Saurabh, Kashid Priyanka, Agarwal Vikas, Rai Pradeep, Sharma Surendra, Murthy L Sreenivasa, Rajurkar Mandodari, Saha Shruti, Patel Piyush, Patil Dipak, Ghadge Pravin, Lakhwani Lalit, Mehta Suyog, Joglekar Sadhna J

机构信息

Department of Endocrinology, Osmania Medical College & Osmania General Hospital, Hyderabad, India.

Department of General Medicine, Priyadarshani Nursing Home, Virar, India.

出版信息

Diabetes Obes Metab. 2025 Apr;27(4):2193-2205. doi: 10.1111/dom.16218. Epub 2025 Feb 14.

DOI:10.1111/dom.16218

PMID:39950245

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11885079/

Abstract

AIM

To evaluate the efficacy and safety of a triple fixed-dose combination (FDC) therapy of dapagliflozin + glimepiride + metformin hydrochloride extended-release (DAPA + GLIM + MET ER) tablets in Indian patients with type 2 diabetes mellitus (T2DM) inadequately controlled by combination of GLIM + MET.

MATERIALS AND METHODS

A phase III, randomized, open-label, active-controlled study was conducted for a maximum 30 weeks (primary treatment [16 weeks]; uptitration [12 weeks] and follow-up [2 weeks]). Eligible patients were randomized in a 1:1 ratio to receive either the FDC of DAPA + GLIM + MET ER or the FDC of GLIM + MET prolonged-release (PR) once-daily. The primary efficacy endpoint was a change in glycated haemoglobin (HbA1c) from baseline to week 16.

RESULTS

The mean reduction in HbA1c from baseline to week 16 was significantly greater with the FDC of DAPA + GLIM + MET ER compared to the FDC of GLIM + MET PR (-1.98% ± 1.01% vs. -1.64% ± 0.86%, p = 0.0047). The mean reduction in HbA1c from baseline to week 12 was significantly greater with the FDC of DAPA + GLIM + MET ER versus dual FDC (p < 0.0001). The proportion of patients achieving HbA1c <7.0% was significantly greater with the FDC of DAPA + GLIM + MET ER versus dual FDC at week 12 (19.1% vs. 6.5%; p = 0.0002) and week 16 (52.6% vs. 36.7%; p = 0.0015). A significant decrease in HbA1c, fasting and post-prandial blood glucose from baseline to weeks 12, 16, and 28 was observed in both arms. The incidence of TEAEs was similar across both arms.

CONCLUSION

This study demonstrated that the FDC of DAPA + GLIM + MET ER tablets once daily was significantly better than dual FDC in achieving glycaemic control in patients with poorly controlled T2DM. Both treatments were well-tolerated.

TRIAL REGISTRATION

CTRI/2022/03/041424, registered on 28 March 2022.

摘要

目的

评估达格列净+格列美脲+盐酸二甲双胍缓释片（DAPA+GLIM+MET ER）三联固定剂量复方制剂（FDC）疗法对印度2型糖尿病（T2DM）患者的疗效和安全性，这些患者使用GLIM+MET联合治疗血糖控制不佳。

材料与方法

进行了一项III期、随机、开放标签、活性对照研究，最长持续30周（初始治疗[16周]；剂量滴定[12周]和随访[2周]）。符合条件的患者按1:1比例随机分组，分别接受DAPA+GLIM+MET ER FDC或每日一次的GLIM+MET缓释（PR）FDC。主要疗效终点是糖化血红蛋白（HbA1c）从基线到第16周的变化。

结果

与GLIM+MET PR FDC相比，DAPA+GLIM+MET ER FDC从基线到第16周HbA1c的平均降幅显著更大（-1.98%±1.01% vs. -1.64%±0.86%，p = 0.0047）。与双联FDC相比，DAPA+GLIM+MET ER FDC从基线到第12周HbA1c的平均降幅显著更大（p < 0.0001）。在第12周（19.1% vs. 6.5%；p = 0.0002）和第16周（52.6% vs. 36.7%；p = 0.0015），DAPA+GLIM+MET ER FDC组达到HbA1c < 7.0%的患者比例显著高于双联FDC组。两组从基线到第12周、16周和28周，HbA1c、空腹和餐后血糖均显著降低。两组治疗中出现的不良事件发生率相似。