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Introduction <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> Methods <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&#xa0;mg) or a dual FDC of sitagliptin and MET IR (SITA + MET IR; 50 + 500/1000&#xa0;mg), administered twice daily for 16&#xa0;weeks. The primary endpoint was the mean change in glycated haemoglobin (HbA1c) from baseline to Week 16.</p> Results <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> &lt; 0.0001. A significantly greater reduction in HbA1c was observed with triple FDC compared to the dual FDC at Week 12 (<i>P</i> &lt; 0.0001). At Week 16, a significantly higher proportion of patients achieved HbA1c &lt; 7% with triple FDC than with dual FDC (48.9% versus 31.1%; <i>P</i> = 0.0029). Both treatments were well tolerated.</p> Conclusion <p>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.</p> Clinical trial registration number <p>CTRI/2022/04/041817.</p>

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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

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  • 发表日期：

    2025年8月19日

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  • 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

摘要

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.

Clinical trial registration number

CTRI/2022/04/041817.