Advances in therapy · 2025
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.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Singh Mahendra Pal, Gupta Sandeep, Singh Manish, Ambrish C, Kurmi Prakash, Gangwani Dinesh Kumar, Naganna J, Sethuraman Ravikumar, Dhumal Vrindavani, Behera Sapan, Patel Piyush M, Patil Dipak M, Lakhwani Lalit K, Ghadge Pravin S, Mehta Suyog C, Joglekar Sadhna J
Аннотация
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.
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.