Phase III SOTA-EMPA study of Zynquista meets primary and secondary endpoints in type 2 diabetes.- Lexicon Pharma

Lexicon Pharmaceuticals announced topline data from the Phase III SOTA-EMPA study for Zynquista (sotagliflozin) in type 2 diabetes. The topline results show that Sotagliflozin 400 mg achieved the primary endpoint of superiority on A1C reduction versus placebo at Week 26 in patients with type 2 diabetes who have inadequate glycemic control on a dipeptidyl peptidase 4 inhibitor (DPP4i) with or without metformin. Sotagliflozin 400 mg also achieved the key secondary endpoint of noninferiority versus empagliflozin on A1C reduction from baseline at Week 26. Sotagliflozin was generally well tolerated with safety results comparable to previously reported results. The full results of SOTA-EMPA, the fourth of nine core Phase III studies in the sotagliflozin type 2 diabetes program, will be presented at future medical conferences.

SOTA-EMPA is a Phase III, multicenter, 2:2:1 randomized, double-blind, placebo- and active-controlled, parallel-group study evaluating the efficacy and safety of sotagliflozin 400 mg compared to empagliflozin 25 mg and placebo in approximately 700 subjects with type 2 diabetes who have inadequate glycemic control on DPP4i with or without metformin. The primary endpoint of the study is superiority of sotagliflozin 400 mg versus placebo on A1C reduction at Week 26 in patients with type 2 diabetes who have inadequate glycemic control on a DPP4i with or without metformin and a key secondary endpoint at Week 26 is noninferiority of sotagliflozin 400 mg versus empagliflozin on A1C reduction from baseline.