Efficacy of dapagliflozin on hepatic steatosis and fibrosis in patients with type 2 diabetes mellitus and metabolic dysfunction-associated steatotic liver disease: a pre-specified single-arm analysis from a randomized controlled trial.

Das Sambit; Das Bijay Ketan; Sahoo Devadarshini; Choudhury Arun Kumar; Meher Dayanidhi; Nath Preetam; Padhee Sourav; Prusty Binod; Agarwal Vishal; Sahu Sandeep Kumar

doi:10.1016/j.diabres.2026.113512

PubMed · 42641810

Efficacy of dapagliflozin on hepatic steatosis and fibrosis in patients with type 2 diabetes mellitus and metabolic dysfunction-associated steatotic liver disease: a pre-specified single-arm analysis from a randomized controlled trial.

Das Sambit·Das Bijay Ketan·Sahoo Devadarshini·Choudhury Arun Kumar·Meher Dayanidhi·Nath Preetam·Padhee Sourav·Prusty Binod·Agarwal Vishal·Sahu Sandeep Kumar

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AIM: To evaluate the association of dapagliflozin therapy with changes in hepatic steatosis and non-invasive fibrosis surrogate markers in patients with type 2 diabetes mellitus (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) over 12 months. METHODS: This is a pre-specified single-arm analysis from a randomised, open-label, parallel-group trial. Of 54 participants randomised to dapagliflozin 10 mg daily, 50 (92.6%) completed the 12-month follow-up and were included in the per-protocol analysis. Assessments at baseline, 3, 6, and 12 months included transient elastography (CAP and LSM), ultrasonography, and biochemical tests. Primary endpoints were changes in hepatic steatosis (CAP) and non-invasive fibrosis surrogates (LSM). RESULTS: Significant reductions were observed in hepatic steatosis (CAP: 316.7 to 245.7 dB/m; mean change - 71.02 dB/m, 95% CI: -63.4 to - 78.6; p < 0.001) and in liver stiffness as a non-invasive fibrosis surrogate (LSM: 8.59 to 7.28 kPa; mean change - 1.31 kPa, 95% CI: -0.92 to - 1.70; p < 0.001). Improvements were also observed in glycaemic control, body weight, lipid profile, liver enzymes, ultrasonographic steatosis grading, and serum fibrosis markers. Genitourinary infections were the most frequently reported adverse events (32%); no serious adverse events were recorded. CONCLUSIONS: Dapagliflozin was associated with significant improvements in hepatic steatosis, non-invasive fibrosis surrogate markers, metabolic parameters, and liver function in T2DM patients with MASLD over 12 months. These findings provide region-specific evidence for an Indian population and support further controlled investigation. However, these findings should be interpreted in light of the pre-specified single-arm design of this analysis, the open-label methodology, relatively small sample size, and the absence of liver biopsy confirmation.

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Das Sambit, Das Bijay Ketan, Sahoo Devadarshini, Choudhury Arun Kumar, Meher Dayanidhi, Nath Preetam, Padhee Sourav, Prusty Binod, Agarwal Vishal, Sahu Sandeep Kumar. 2026-08-25. Efficacy of dapagliflozin on hepatic steatosis and fibrosis in patients with type 2 diabetes mellitus and metabolic dysfunction-associated steatotic liver disease: a pre-specified single-arm analysis from a randomized controlled trial.. https://doi.org/10.1016/j.diabres.2026.113512

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Journal Article; Randomized Controlled Trial resource Adult subject Aged subject Benzhydryl Compounds subject Dapagliflozin subject Diabetes Mellitus, Type 2 subject Fatty Liver subject Female subject Glucosides subject Humans subject Journal Article subject Liver subject Male subject Middle Aged subject Randomized controlled trials study hepatic steatosis subject

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