A randomized, double-blind, active-controlled trial assessing the efficacy and safety of a fixed-dose combination (FDC) of MEtformin hydrochloride 1000 mg ER, SItagliptin phosphate 100 mg, and DApagliflozin propanediol 10 mg in Indian adults with type 2 diabetes: The MESIDA trial

IF 0.7 4区医学 Q4 ENDOCRINOLOGY & METABOLISM International Journal of Diabetes in Developing Countries Pub Date : 2024-02-17 DOI:10.1007/s13410-024-01321-9

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Abstract

Objective

To assess the efficacy and safety of fixed-dose combinations (FDC) of triple-drug dapagliflozin, sitagliptin, and metformin (DSM) compared with FDC of two-drug sitagliptin and metformin (SM), in Indian adult patients with type 2 diabetes (T2D).

Methods

A multicentric, randomized, double-blind, active-controlled, Phase 3 study (CTRI/2021/10/037461) was conducted on 274 Indian adult patients with T2D. Patients were randomized (1:1) to receive either an FDC of triple-drug (n = 137) dapagliflozin propanediol 10 mg, sitagliptin phosphate 100 mg, and metformin hydrochloride 1000 mg extended-release (DSM) or FDC of two-drug (n = 137) sitagliptin phosphate 100 mg and metformin hydrochloride 1000 mg sustained-release (SM), for 16 weeks. The primary endpoint was a change in HbA1c, while the secondary endpoints were changes in fasting plasma glucose (FPG), postprandial glucose (PPG), body weight, and safety.

Results

Both DSM and SM FDCs reduced HbA1c significantly (-1.45% and -1.00%, respectively, both p < 0.0001), however, HbA1c lowering was superior with DSM (∆ -0.45%; p = 0.0005) compared to SM, at week 16. Similarly, both DSM and SM FDCs reduced FPG and PPG significantly, however, FPG (∆ -12.4 mg/dl; p = 0.003) and PPG reduction (∆ -18.45 mg/dl; p = 0.01) were significantly superior to DSM compared to SM, respectively. No significant reduction in body weight was observed between the two arms. Both FDCs were well tolerated.

Conclusion

FDC of DSM was superior to SM in reducing HbA1c, FPG, and PPG in Indian adults with T2D. Both triple and dual FDCs had optimal safety profiles.

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一项随机、双盲、主动对照试验，评估了盐酸甲福明 1000 毫克 ER、磷酸西格列汀 100 毫克和 10 毫克帕格列非嗪丙二醇固定剂量复方制剂 (FDC) 在印度成年 2 型糖尿病患者中的疗效和安全性：MESIDA 试验

摘要目的评估达帕格列净、西格列汀和二甲双胍三药固定剂量联合用药（FDC）与西格列汀和二甲双胍两药固定剂量联合用药（FDC）在印度成年 2 型糖尿病（T2D）患者中的疗效和安全性。方法对 274 名印度成年 2 型糖尿病患者进行了一项多中心、随机、双盲、主动对照 3 期研究（CTRI/2021/10/037461）。患者被随机分配（1:1）接受三联药物（n = 137）达帕格列嗪丙二醇 10 毫克、磷酸西格列汀 100 毫克和盐酸二甲双胍 1000 毫克缓释（DSM）的 FDC 或两联药物（n = 137）磷酸西格列汀 100 毫克和盐酸二甲双胍 1000 毫克缓释（SM）的 FDC，为期 16 周。主要终点是 HbA1c 的变化，次要终点是空腹血浆葡萄糖 (FPG)、餐后血糖 (PPG)、体重和安全性的变化。结果 DSM 和 SM FDC 均能显著降低 HbA1c（分别为-1.45%和-1.00%，p 均为 0.0001），但在第 16 周时，DSM 的 HbA1c 降低效果优于 SM（∆ -0.45%; p = 0.0005）。同样，DSM 和 SM FDC 均能显著降低 FPG 和 PPG，但与 SM 相比，DSM 的 FPG 降幅（∆ -12.4 mg/dl；p = 0.003）和 PPG 降幅（∆ -18.45 mg/dl；p = 0.01）明显优于 SM。两组患者的体重均未出现明显降低。两种 FDC 的耐受性均良好。结论 DSM 的 FDC 在降低印度成年 T2D 患者的 HbA1c、FPG 和 PPG 方面优于 SM。三联和双联 FDC 均具有最佳安全性。

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来源期刊

International Journal of Diabetes in Developing Countries ENDOCRINOLOGY & METABOLISM-

CiteScore

1.60

自引率

0.00%

发文量

109

审稿时长

6 months

期刊介绍： International Journal of Diabetes in Developing Countries is the official journal of Research Society for the Study of Diabetes in India. This is a peer reviewed journal and targets a readership consisting of clinicians, research workers, paramedical personnel, nutritionists and health care personnel working in the field of diabetes. Original research articles focusing on clinical and patient care issues including newer therapies and technologies as well as basic science issues in this field are considered for publication in the journal. Systematic reviews of interest to the above group of readers are also accepted.