Lexicon Pharmaceuticals announced positive top-line results from its Phase 3 inTandem3 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for the treatment of patients with type 1 diabetes on any background insulin therapy. The study met its primary endpoint, demonstrating the superiority of sotagliflozin 400 mg compared to placebo in the proportion of patients with A1C <7.0% at Week 24 and no episode of severe hypoglycemia and no episode of diabetic ketoacidosis (DKA) after randomization.
Sotagliflozin demonstrated a generally well tolerated safety profile during a 24-week treatment period, with rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to AEs that were consistent with rates seen in two prior pivotal Phase 3 studies, inTandem1 and inTandem2, including a similar rate of severe hypoglycemia for the sotagliflozin arm compared to placebo during the 24-week treatment period (2.4% for placebo compared to 3.0% for sotagliflozin 400 mg) and a slightly higher rate of DKA during the 24-week treatment period for sotagliflozin 400 mg (3.0%) than placebo (0.6%).
"The results achieved with sotagliflozin in the inTandem3 study are scientifically and clinically important and significant," Satish Garg, M.D., lead investigator of inTandem3 and Professor of Medicine and Pediatrics, and Director Adult Program at the Barbara Davis Center for Diabetes, University of Colorado Denver and Editor-in-Chief, Diabetes Technology and Therapeutics said. "If approved, sotagliflozin may potentially be the first option as an adjunct to insulin to improve glycemic control for patients with type 1 diabetes."