Comparative Efficacy and Safety of Remogliflozin 100 mg Versus Dapagliflozin 10 mg in Patients with T2DM and CKD: A Randomized, Open-Label Study

Abstract

Background: In diabetic patients, managing glycaemic control while preserving renal function is a challenge, necessitating the use of sodium-glucose cotransporter-2 inhibitors, which have demonstrated reno-protective and cardiovascular benefits. Remogliflozin, a novel sodium-glucose co transporter-2 inhibitors, has shown efficacy in glycemic control, but its renal effects in chronic kidney disease patients remain unexplored.

Aim: To assess the non-inferiority of remogliflozin compared to dapagliflozin in terms of renal and glycaemic parameters in patients with Type 2 diabetes mellitus and chronic kidney disease.

Methods: A prospective, multicentre, randomized, open-label, active-controlled, non-inferiority study was conducted in patients diagnosed with Type 2 diabetes mellitus and chronic kidney disease. Participants were assigned to receive either remogliflozin or dapagliflozin over a treatment period of 24 weeks. Primary endpoints included changes in renal parameters such as estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, serum creatinine, blood urea nitrogen, and uric acid. Secondary endpoints included measures of glycemic control, body weight, and safety outcomes.

Results: Both treatment groups showed significant improvement in renal parameters from baseline to weeks 12 and 24 (p<0.001), with no significant difference between groups. Glycaemic parameters also improved significantly in both groups, with similar mean % reductions in HbA1c [Remogliflozin: 8.46% to 7.40%; Dapagliflozin: 8.11%to 7.49%]. The incidence of a ≥50% sustained decline in eGFR was comparable (Remogliflozin: 9.46%; Dapagliflozin: 6.67%; p>0.05). End-stage renal disease was observed in 4.05% and 2.67% of patients in the remogliflozin and dapagliflozin groups, respectively. No cases of cardiovascular or renal death were reported. Both groups demonstrated reductions in body weight and body mass index. Adverse events were mild and comparable between groups, with no serious safety concerns.

Conclusion: Remogliflozin demonstrated non-inferiority to dapagliflozin in renal and glycaemic outcomes, with a comparable safety profile. These findings suggest that remogliflozin is a viable treatment option for patients with Type 2 diabetes mellitus and chronic kidney disease. Further long-term studies are warranted to validate these findings.