Abstract / Summary
Introduction: Remogliflozin is a sodium–glucose cotransporter-2 inhibitor used for type 2 diabetes mellitus (T2DM), but its overall efficacy and safety remain fragmented. This updated systematic review and meta-analysis evaluated the efficacy and safety of remogliflozin using evidence exclusively from randomized controlled trials (RCTs). Methods: PubMed; Scopus; and the Cochrane Library were searched from inception to 15 July 2026 for RCTs lasting at least 12 weeks that compared remogliflozin or a remogliflozin-containing regimen with placebo; usual care; or another glucose-lowering treatment in adults with T2DM (PROSPERO: CRD420261462138). Risk ratios (RRs) were calculated using the Mantel–Haenszel method and mean differences (MDs) using the inverse-variance method. Random-effects models with restricted maximum-likelihood estimation and Hartung–Knapp adjustment were applied. Heterogeneity was assessed using I2 and Cochran’s Q test. Results: Nine RCTs involving 1731 participants were included, of whom 906 (52.3%) received remogliflozin or a remogliflozin-containing regimen. Across heterogeneous comparator regimens, remogliflozin-containing treatment strategies were associated with lower HbA1c (MD −0.40 percentage points; 95% CI −0.63 to −0.16; I2 = 59.9%; p < 0.01) and body weight (MD −2.15 kg; 95% CI −3.26 to −1.03; I2 = 56.5%; p < 0.01). No statistically significant differences were detected for fasting plasma glucose (MD −6.84 mg/dL; 95% CI −16.07 to 2.38; I2 = 59.4%; p = 0.150), total adverse events (RR 1.16; 95% CI 0.93–1.43; I2 = 0%; p = 0.155), or hypoglycaemia (RR 0.89; 95% CI 0.28–2.81; I2 = 0%; p = 0.696); however, the safety estimates, particularly for hypoglycaemia, were imprecise. Conclusions: Across heterogeneous randomized comparisons, remogliflozin-containing treatment strategies were associated with modest reductions in HbA1c and body weight, whereas the effect on fasting plasma glucose remained inconclusive. The available evidence was insufficient to establish whether total adverse events or hypoglycaemia differed between treatment groups because of the small evidence base, short follow-up, sparse events, and imprecise estimates.