Sotagliflozin Decreases AIC in Phase III Trial in Type 1 Diabetes

Lexicon Pharmaceuticals announced that a Phase III clinical trial of sotagliflozin met its primary endpoint, demonstrating a significant reduction in A1C at 24 weeks in patients with type 1 diabetes on a background of optimized insulin.

Lexicon is conducting a similar Phase III trial in Europe, which is expected to report top-line results by the end of the year. A third Phase III trial is underway globally, studying approximately 1,400 patients treated with sotagliflozin 400 mg once daily or placebo on a background of any insulin therapy, but without insulin optimization prior to randomization.

Lexicon previously granted Sanofi a worldwide license to develop sotagliflozin, and Sanofi is planning to initiate Phase III clinical trials in type 2 diabetes by the end of the year.