Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on developing breakthrough treatments for human disease, today announced that it has commenced screening in its first pivotal Phase 3 clinical trial of sotagliflozin for type 1 diabetes.
"We are pleased to achieve this important milestone in sotagliflozin's Phase 3 development on schedule," said Lonnel Coats, Lexicon's president and chief executive officer. "We believe this first-in-class, dual SGLT1 and SGLT2 inhibitor has the potential to provide unique benefits to individuals with type 1 diabetes."
Lexicon will be conducting two pivotal Phase 3 clinical trials of sotagliflozin, one in North America and another primarily in Europe. Each pivotal trial is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety and tolerability of sotagliflozin in adult patients with type 1 diabetes. Two dose levels of sotagliflozin, 200mg and 400mg once daily, will be tested along with placebo. The primary efficacy endpoint under evaluation will be reduction of A1C versus placebo on optimized insulin treatment at 24 weeks, with secondary endpoints including percentage of patients achieving A1C levels of less than 7%, reduction in meal-time, or bolus, insulin use and weight loss. Additional information on the North American study can be found at www.clinicaltrials.gov by using the identifier NCT02384941.
Lexicon is a biopharmaceutical company focused on developing breakthrough treatments for human disease. Lexicon has clinical-stage drug programs for diabetes, carcinoid syndrome, and other indications, all of which were discovered by Lexicon's research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. For additional information about Lexicon and its programs, please visit www.lexpharma.com.