Post by icemandios on Dec 20, 2019 13:20:11 GMT
Lexicon Pharmaceuticals Announces Topline Phase 3 Data for Sotagliflozin in Type 2 Diabetes
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.
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.”
About SOTA-EMPA
SOTA-EMPA is a Phase 3, 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.
About Zynquista (sotagliflozin)
Discovered using Lexicon’s unique approach to gene science, Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Zynquista is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.
About Lexicon Pharmaceuticals
