Impact of Dapagliflozin (Sodium-glucose Transport Protein 2 Inhibitor) on Liver Steatosis and Fibrosis in Subjects with Type 2 Diabetes Mellitus and Metabolic Dysfunction-associated Steatotic Liver Disease

AIM: In type 2 diabetes mellitus (T2DM), Metabolic dysfunction-associated steatotic liver disease (MASLD) is emerging as a significant health problem; however, the treatment options appear to be restricted despite an overlap between MASLD and diabetes. The present trial was conducted to investigate the efficacy of SGLT-2 inhibitor (dapagliflozin) in improving the metabolic and liver parameters in MASLD and type 2 diabetes. MATERIALS AND METHODS: A 24-week randomized controlled trial evaluated the role of dapagliflozin (10 mg/day) in MASLD and T2DM patients. 1:1 randomization was done into dapagliflozin plus standard care ( n = 34) or standard care alone ( n = 30). Changes in liver steatosis (Ultrasonography [USG]), fibrosis (fibroscan, fibrosis-4, and aspartate aminotransferase (AST)-to-platelet ratio index [APRI]), and biochemical markers were analyzed. Data were analyzed using SPSS, and P < 0.05 was considered significant. RESULTS: At the 24-week follow-up, a significant reduction in AST ( P = 0.027) and alanine aminotransferase ( P = 0.002) levels was observed in the dapagliflozin group. Significant decline in triglycerides ( P = 0.020) and an increase in high-density lipoprotein cholesterol ( P = 0.001) were observed. No significant differences were observed in liver stiffness measurement, FIB4, and glycated hemoglobin levels; however, the APRI score declined significantly ( P = 0.038). The intervention group maintained a higher body mass index ( P = 0.037) but showed hepatic improvements. No adverse events were reported during the trial, and the drug was well-tolerated. CONCLUSIONS: Dapagliflozin (SGLT-2 inhibitor) significantly reduces markers of dyslipidemia and liver injury in MASLD and type 2 diabetes patients, and this effect appears to be independent of weight loss. Results of a 24-week trial showed a decrease in inflammation; a longer-duration trial will establish significant improvement in hepatic fibrosis.