940-P: Efficacy and Safety of Enavogliflozin vs. Dapagliflozin as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Based on Renal Function—A Pooled Analysis of Two Randomized Controlled Trials

Introduction & Objective: We assessed the efficacy and safety of enavogliflozin 0.3 mg, a newly developed SGLT-2 inhibitor, in patients with type 2 diabetes mellitus based on kidney function via pooled analysis of two 24-week, randomized, double-blind phase III trials.

Methods: Data from 470 patients were included (enavogliflozin: 0.3 mg/day, n = 235; dapagliflozin: 10 mg/day, n = 235). The subjects were classified by mildly reduced (60 ≤ eGFR < 90mL/min/1.73 m², n = 247) or normal eGFR (≥ 90 mL/min/1.73 m², n = 223).

Results: In the mildly reduced eGFR group, enavogliflozin significantly reduced adjusted mean change of HbA1c and fasting plasma glucose levels at week 24 compared to dapagliflozin (−0.94% vs. −0.77%, P = 0.0196). Enavogliflozin showed potent blood glucose-lowering effects regardless of renal function (HbA1c: -0.84% and -0.96% in the normal and mildly reduced eGFR groups, respectively, P = 0.0744). Conversely, dapagliflozin significantly decreased the glucose-lowering efficacy as the renal function decreased (HbA1c: -0.95% and -0.80% in the normal and mildly reduced eGFR group, respectively, P = 0.0488). Enavogliflozin 0.3 mg induced a higher urinary glucose excretion rate in both groups. The enavogliflozin group showed a significant decrease in the insulin resistance homeostatic model. No significant differences in blood pressure, weight loss, or HOMA-β values were observed between enavogliflozin and dapagliflozin. Adverse events were similar between drugs.

Conclusions: This analysis suggests the superior glucose-lowering efficacy of enavogliflozin over dapagliflozin in patients with type 2 diabetes mellitus with mild renal function impairment, attributed to its potent urinary glucose excretion.