P104 - Impact of Sotagliflozin, a Dual Sodium-Glucose Cotransporter 1-2 Inhibitor, as Add-on to Inadequately Controlled Basal Insulin-Treated Type 2 Diabetes

Sotagliflozin (SOTA), a dual SGLT1 and SGLT2 inhibitor, is indicated to reduce the risk of CV death and hospitalization for heart failure (HF) in adults with HF or type 2 diabetes (T2D), chronic kidney disease, and other CV risk factors. SOTA has previously demonstrated glycemic efficacy as an adjunct to insulin therapy in patients with type 1 diabetes (InTandem program). This poster discusses a study that assessed the safety and efficacy of SOTA in T2D participants with inadequate glycemic control on basal insulin with up to two glucose-lowering oral agents. This was a Phase 3, multicenter, double-blind, placebo (PBO)-controlled, parallel-group study that enrolled 570 T2D participants (baseline mean HbA1c 8.45%, age 62.4 yrs, T2D duration 14.8 yrs, BMI 32.4kg/m2, basal insulin dose 51 IU), who were randomized 2:1:1 to once daily SOTA 400 mg, SOTA 200 mg, or PBO. SOTA 400 mg once day significantly improved HbA1c in T2D with inadequate glycemic control on basal insulin therapy with a slight increase in non-severe hypoglycemia.