Efficacy and safety of enavogliflozin, a novel SGLT2 inhibitor, in Korean people with type 2 diabetes: A 24‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase III trial.

Aims: To evaluate the efficacy and safety of a novel sodium‐glucose cotransporter 2 inhibitor, enavogliflozin 0.3 mg monotherapy, in Korean people with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise. Materials and Methods: This study was a randomized, double‐blind, placebo‐controlled trial conducted in 23 hospitals. Individuals with haemoglobin A1c (HbA1c) of 7.0%‐10.0% after at least 8 weeks of diet and exercise modification were randomized to receive enavogliflozin 0.3 mg (n = 83) or placebo (n = 84) for 24 weeks. The primary outcome was a change in HbA1c at week 24 from baseline. Secondary outcomes included the proportion of participants achieving HbA1c <7.0%, change in fasting glucose, body weight and lipid levels. Adverse events were investigated throughout the study. Results: At week 24, the placebo‐adjusted mean change in HbA1c from baseline in the enavogliflozin group was −0.99% (95% confidence interval −1.24%, −0.74%). The proportions of patients achieving HbA1c <7.0% (71% vs. 24%) at week 24 was significantly higher in the enavogliflozin group (p <.0001). Placebo‐adjusted mean changes in fasting plasma glucose (−40.1 mg/dl) and body weight (−2.5 kg) at week 24 were statistically significant (p <.0001). In addition, a significant decrease in blood pressure, low‐density lipoprotein cholesterol, triglyceride, and homeostasis model assessment of insulin resistance were observed, along with a significant increase in high‐density lipoprotein cholesterol. No significant increase in treatment‐related adverse events was observed for enavogliflozin. Conclusions: Monotherapy with enavogliflozin 0.3 mg improved glycaemic control in people with T2DM. Enavogliflozin therapy also exerted beneficial effects on body weight, blood pressure and lipid profile. [ABSTRACT FROM AUTHOR]