Add-on therapy with a selective SGLT2i improved glycemic and metabolic outcomes in insulin-treated type 2 diabetes mellitus (T2DM). This double-blind, placebo-controlled trial, published in Diabetes & Metabolism Journal, evaluated enavogliflozin in adults with T2DM inadequately controlled with insulin, with or without oral antidiabetic drugs (OADs).

Adults from South Korea and Thailand with glycosylated hemoglobin (HbA1c) ≥7.5% despite stable background insulin therapy were randomized to enavogliflozin or placebo for 24 weeks. The primary endpoint was change in HbA1c. Secondary endpoints included fasting plasma glucose (FPG), body weight, blood pressure, total daily insulin dose, and safety outcomes.

At week 24, enavogliflozin reduced HbA1c by 0.9% versus placebo (P < 0.001). FPG declined by 32.4 mg/dL (P < 0.001), body weight decreased by 1.3 kg (P < 0.001), and total daily insulin dose fell by 1.3 units (P = 0.010). Blood pressure decreased significantly. Fasting C-peptide declined, while homeostasis model assessment of β-cell function (HOMA-β) increased, without change in homeostasis model assessment of insulin resistance (HOMA-IR). Treatment-related adverse events did not differ from placebo.

These findings indicate that enavogliflozin provides effective glycemic improvement without additional safety risk when used as an add-on to insulin therapy in T2DM.