Phase III inTandem1 study for LX 4211 published in Diabetes Care journal.- Lexicon Pharmaceuticals.

Lexicon Pharmaceuticals announced positive 52-week results from the Phase III inTandem1 study for LX 4211 (sotagliflozin) in adults with type 1 diabetes. In the North American study, administration of sotagliflozin 200 mg or 400 mg in combination with maximally tolerated standard of care insulin therapy resulted in statistically significant reductions in A1C levels and weight compared to optimized insulin alone. A lower incidence of severe hypoglycemia was observed with sotagliflozin 200 mg and 400 mg compared to placebo. New 52-week findings from inTandem1, a 793-patient double-blind, placebo-controlled Phase 3 study, demonstrated that sotagliflozin, in combination with insulin, significantly reduced A1C, weight, total daily insulin dose and fasting plasma glucose (FPG) compared to placebo, with a lower incidence of severe hypoglycemia.

In addition, more patients taking sotagliflozin in combination with optimized insulin achieved the combined goal of an average blood sugar level below the ADA-recommended target without severe hypoglycemia and without diabetic ketoacidosis (DKA), also referred to as net clinical benefit. A total of 6.5% of patients in each of the sotagliflozin 200 mg and 400 mg cohorts reported episodes of severe hypoglycemia compared to 9.7% of patients on placebo.

A total of 3.4% of patients on sotagliflozin 200 mg and 4.2% of patients on sotagliflozin 400 mg experienced DKA compared to 0.4% of patients on placebo. Study authors indicate that the DKA risk could potentially be mitigated with patient education and monitoring. The results were presented at the American Diabetes Association and were published in Diabetes Care.

See: Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1 Diabetes: The North American inTandem1 Study