Lexicon Pharmaceuticals Announces Topline Phase 3 Data for Sotagliflozin in Type 2 Diabetes
THE WOODLANDS, Texas, Dec. 20, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (LXRX) (Nasdaq: LXRX), today announced topline data from the Phase 3 SOTA-EMPA study for sotagliflozin (Zynquista™) in type 2 diabetes. The topline results are as follows:
- 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 3 studies in the sotagliflozin type 2 diabetes program, will be presented at future medical conferences.
“We are pleased that today’s results demonstrate sotagliflozin achieved a clinical profile comparable to the efficacy of empagliflozin and a safety profile consistent with previously reported results,” said Pablo Lapuerta, M.D., executive vice president and chief medical officer at Lexicon. “We look forward to the release of topline data from the remainder of the core Phase 3 sotagliflozin studies in type 2 diabetes in early 2020.”
