Mahendra Pal Singh, Sandeep Gupta, Manish Singh, C. Ambrish, Prakash Kurmi, Dinesh Kumar Gangwani, J. Naganna, Ravikumar Sethuraman, Vrindavani Dhumal, Sapan Behera, Piyush M. Patel, Dipak M. Patil, Lalit K. Lakhwani, Pravin S. Ghadge, Suyog C. Mehta, Sadhna J. Joglekar
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Joglekar","doi":"10.1007/s12325-025-03323-3","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>This study aims to evaluate the efficacy and safety of a triple fixed-dose combination (FDC) of dapagliflozin, sitagliptin, and immediate-release metformin (DAPA + SITA + MET IR) compared to dual FDCs in patients with type 2 diabetes mellitus (T2DM).</p><h3>Methods</h3><p>This Phase 3, randomized, open-label study included eligible patients with T2DM who were randomly assigned in a 1:1 ratio to receive either a triple FDC of DAPA + SITA + MET IR (5 + 50 + 500/1000 mg) or a dual FDC of sitagliptin and MET IR (SITA + MET IR; 50 + 500/1000 mg), administered twice daily for 16 weeks. The primary endpoint was the mean change in glycated haemoglobin (HbA1c) from baseline to Week 16.</p><h3>Results</h3><p>The mean baseline HbA1c was ~ 9% in both arms. Adjusted mean reduction in HbA1c from baseline to Week 16 was significantly greater in triple FDC of DAPA + SITA + MET IR (– 2.08%) versus dual FDC of SITA + MET IR (– 1.38%) <i>P</i> < 0.0001. A significantly greater reduction in HbA1c was observed with triple FDC compared to the dual FDC at Week 12 (<i>P</i> < 0.0001). At Week 16, a significantly higher proportion of patients achieved HbA1c < 7% with triple FDC than with dual FDC (48.9% versus 31.1%; <i>P</i> = 0.0029). Both treatments were well tolerated.</p><h3>Conclusion</h3><p>Triple FDC of DAPA + SITA + MET IR demonstrated superior efficacy in achieving glycaemic control in patients with T2DM compared to dual FDC. 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Adjusted mean reduction in HbA1c from baseline to Week 16 was significantly greater in triple FDC of DAPA + SITA + MET IR (– 2.08%) versus dual FDC of SITA + MET IR (– 1.38%) <i>P</i> < 0.0001. A significantly greater reduction in HbA1c was observed with triple FDC compared to the dual FDC at Week 12 (<i>P</i> < 0.0001). At Week 16, a significantly higher proportion of patients achieved HbA1c < 7% with triple FDC than with dual FDC (48.9% versus 31.1%; <i>P</i> = 0.0029). Both treatments were well tolerated.</p><h3>Conclusion</h3><p>Triple FDC of DAPA + SITA + MET IR demonstrated superior efficacy in achieving glycaemic control in patients with T2DM compared to dual FDC. 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引用次数: 0
摘要
本研究旨在评价达格列净、西格列汀和速释二甲双胍（DAPA + SITA + MET IR）三种固定剂量联合治疗（FDC）与双固定剂量联合治疗2型糖尿病（T2DM）患者的疗效和安全性。方法：这项3期随机、开放标签研究纳入了符合条件的T2DM患者，他们以1:1的比例随机分配，接受DAPA + SITA + MET IR的三重FDC （5 + 50 + 500/1000 mg）或西格列汀和MET IR的双重FDC (SITA + MET IR; 50 + 500/1000 mg)，每天两次，持续16周。主要终点是糖化血红蛋白（HbA1c）从基线到第16周的平均变化。结果：两组患者的平均基线HbA1c为~ 9%。与SITA + MET IR的双重FDC相比，DAPA + SITA + MET IR的三重FDC从基线到第16周的调整后平均HbA1c降低（- 2.08%）显著高于SITA + MET IR的双重FDC（- 1.38%）。结论：与双重FDC相比，DAPA + SITA + MET IR的三重FDC在实现T2DM患者血糖控制方面表现出更优越的疗效。没有重大的安全问题。临床试验注册号：CTRI/2022/04/041817。
Efficacy and Safety of Triple Fixed Dose Combination of Dapagliflozin + Sitagliptin + Metformin IR in Indian Patients with Type 2 Diabetes Mellitus: A Randomized, Phase 3 Study in Comparison with Dual FDC Sitagliptin + Metformin IR
Introduction
This study aims to evaluate the efficacy and safety of a triple fixed-dose combination (FDC) of dapagliflozin, sitagliptin, and immediate-release metformin (DAPA + SITA + MET IR) compared to dual FDCs in patients with type 2 diabetes mellitus (T2DM).
Methods
This Phase 3, randomized, open-label study included eligible patients with T2DM who were randomly assigned in a 1:1 ratio to receive either a triple FDC of DAPA + SITA + MET IR (5 + 50 + 500/1000 mg) or a dual FDC of sitagliptin and MET IR (SITA + MET IR; 50 + 500/1000 mg), administered twice daily for 16 weeks. The primary endpoint was the mean change in glycated haemoglobin (HbA1c) from baseline to Week 16.
Results
The mean baseline HbA1c was ~ 9% in both arms. Adjusted mean reduction in HbA1c from baseline to Week 16 was significantly greater in triple FDC of DAPA + SITA + MET IR (– 2.08%) versus dual FDC of SITA + MET IR (– 1.38%) P < 0.0001. A significantly greater reduction in HbA1c was observed with triple FDC compared to the dual FDC at Week 12 (P < 0.0001). At Week 16, a significantly higher proportion of patients achieved HbA1c < 7% with triple FDC than with dual FDC (48.9% versus 31.1%; P = 0.0029). Both treatments were well tolerated.
Conclusion
Triple FDC of DAPA + SITA + MET IR demonstrated superior efficacy in achieving glycaemic control in patients with T2DM compared to dual FDC. There were no major safety concerns.
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.
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