Real‐world effectiveness and safety of enavogliflozin in patients with type 2 diabetes: A 24‐week prospective multicenter observational study in Korea

AIMS/INTRODUCTION: To evaluate the real-world effectiveness and safety of enavogliflozin as a single-pill formulation (Enavo group; enavogliflozin 0.3 mg) or fixed-dose combination with metformin (EnavoMet group; enavogliflozin 0.3 mg/metformin 1000 mg) in patients with type 2 diabetes (T2DM) in Korean primary care. MATERIALS AND METHODS: This prospective, multicenter, non-interventional observational study enrolled 8796 adults with type 2 diabetes mellitus from 273 primary care clinics across Korea (Safety Set). The full analysis set comprised 8704 participants (Enavo: 7046; EnavoMet: 1658) with baseline and at least one post-baseline glycated hemoglobin (HbA1c) measurement. The primary endpoint was HbA1c change at 24 weeks. RESULTS: At 24 weeks, mean HbA1c decreased by -0.69 percentage points (95% CI: -0.71, -0.67) in Enavo (n = 7003) and -0.86 (-0.90, -0.82) in EnavoMet (n = 1648). In these paired cohorts, 1728 (24.7%) and 371 (22.5%), respectively, already had HbA1c <7.0% at baseline. Overall 24-week HbA1c <7.0% rates were 61.6% and 63.6%, combining maintenance and new attainment; <6.5% rates were 30.0% and 37.2%. Weight and systolic blood pressure decreased (-2.43/-2.73 kg; -3.05/-3.77 mmHg). Adverse events were recorded in 39 participants (0.44%); no serious events were recorded. CONCLUSIONS: Enavogliflozin use was associated with decreases in HbA1c, body weight, and blood pressure over 24 weeks. Overall target rates include participants already below target at baseline and do not establish causal treatment effects.