Trial reportAdvances in therapy2025
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.
Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis 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).
methodsThis 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.
resultsThe 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.
conclusionTriple 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.
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