Lexicon Pharmaceuticals, Inc.: sotagliflozin

Diabetic ketoacidosis (DKA) was observed in the sotagliflozin dose groups compared to placebo in all three of the phase 3 clinical trials conducted in patients with T1D.

We also acknowledge that the post hoc subgroup analyses of CFB A1C for patients with T1D and CKD were generally consistent with the primary analyses conducted in support of the original NDA submission.