Efficacy of Dapagliflozin + Sitagliptin + Metformin Versus Sitagliptin + Metformin in T2DM Inadequately Controlled on Metformin Monotherapy: A Multicentric Randomized Trial

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2024-12-05 DOI:10.1007/s12325-024-03037-y

Awadhesh Kumar Singh, Ashok Kumar Das, L. Sreenivasa Murthy, Samit Ghosal, Rakesh Sahay, K. V. S. Harikumar, Ganesh Hosahithlu Keshava, Mayur Agarwal, G. Vijayakumar, Pramila Kalra, Piyush Lodha, Sambit Das, Shehla Shaikh, Soumik Goswami, T. P. Ajish, Prashant Kumthekar, Mihir Upadhyay, Anthuvan Thamburaj, Aushili Mahule, Ashish Prasad, Abhijit Pednekar

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引用次数: 0

Abstract

Introduction

A slower adoption rate of fixed dose combinations (FDC) in diabetes management is partly due to insufficient data. This study evaluates the safety and efficacy of an FDC of dapagliflozin + sitagliptin + metformin hydrochloride extended release (XR), compared to a dual FDC of sitagliptin + metformin hydrochloride XR among patients with type 2 diabetes mellitus (T2DM) with poor glycemic control when treated with metformin monotherapy.

Methods

A total of 274 patients with T2DM were randomized (1:1) to either arm X, receiving FDC of dapagliflozin (10 mg) + sitagliptin (100 mg) + metformin hydrochloride XR (1000 mg) (Dapa + Sita + Met) tablets, or arm Y, receiving sitagliptin phosphate (100 mg) + metformin hydrochloride XR (1000 mg) (Sita + Met) tablets, and treated for 16 weeks. The outcome measures included changes in hemoglobin A1c (HbA1c)(%), fasting plasma glucose (FPG), 2-h post-prandial glucose (PPG), weight, and the proportion of patients achieving target HbA1c levels of < 7.0% by week 16 of the study period.

Results

The reduction in HbA1c at week 16 was significantly higher in arm X than in arm Y [estimated treatment difference (ETD), − 0.65% (95% CI − 0.76 to − 0.53; P < 0.0001)]. Arm X showed a marked decrease in FPG [ETD − 15.42 mg/dl; 95% CI (17.63, 13.22; P < 0.0001)], PPG [ETD − 30.39 mg/dl; 95% CI (35.59, 25.19; P < 0.0001)], and weight [ETD − 1.47 kg; 95% CI (1.59, 1.28; P < 0.0001)] after 16 weeks. In arm X, 54% of patients reached HbA1c < 7.0% compared to 29.9% in arm Y. The incidence of adverse events was comparable [13.14% (arm X) vs 12.4% (arm Y)]. There was no severe hypoglycemia-led treatment discontinuation.

Conclusion

Among patients with T2DM who have poor glycemic control with metformin monotherapy, triple FDC (Dapa + Sita + Met) effectively helped achieve better glycemic response compared to dual FDC (Sita + Met), with a comparable safety and tolerability profile.

Trial Registration

CTRI/2022/01/039857

查看原文本刊更多论文

达格列净+西格列汀+二甲双胍与西格列汀+二甲双胍单药治疗控制不充分的T2DM的疗效：一项多中心随机试验

导论：固定剂量联合用药（FDC）在糖尿病管理中的采用率较慢，部分原因是数据不足。本研究评估了达格列净+西格列汀+盐酸二甲双胍缓释（XR）的FDC与西格列汀+盐酸二甲双胍XR的双重FDC在二甲双胍单药治疗血糖控制不良的2型糖尿病（T2DM）患者中的安全性和有效性。方法：共274例T2DM患者随机（1:1）分为两组，X组接受达格列净(10 mg) +西格列汀(100 mg) +盐酸二甲双胍XR (1000 mg) （Dapa + Sita + Met）片的FDC治疗，Y组接受磷酸西格列汀(100 mg) +盐酸二甲双胍XR (1000 mg) （Sita + Met）片，治疗16周。结果测量包括血红蛋白A1c (HbA1c)（%）、空腹血糖（FPG）、餐后2小时血糖（PPG）、体重的变化，以及达到目标HbA1c水平的患者比例。结果：第16周HbA1c的降低在X组显著高于Y组[估计治疗差异（ETD）， - 0.65% (95% CI - 0.76至- 0.53；结论：在接受二甲双胍单药治疗血糖控制不良的T2DM患者中，三联FDC （Dapa + Sita + Met）比双联FDC （Sita + Met）有效地帮助获得更好的血糖反应，具有相当的安全性和耐受性。试验报名：CTRI/2022/01/039857。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.