Lexicon Pharmaceuticals (NASDAQ:LXRX) reported topline data from its Phase 3 study of sotagliflozin for the treatment of Type 2 diabetes (T2D).
Sotagliflozin is an oral dual inhibitor of sodium-glucose co-transporter types 1 and 2, which are responsible for glucose absorption in the gastrointestinal tract and kidneys, respectively.
The Phase 3 trial compared 400 mg of sotagliflozin, 25 mg of empagliflozin and placebo in some 700 T2D patients with inadequate glycemic control on a dipeptidyl peptidase 4 inhibitor, with or without metformin.
The study met its primary endpoint of superiority of 400 mg of sotagliflozin versus placebo on A1C reduction and a key secondary endpoint of noninferiority of 400 mg of sotagliflozin versus empagliflozin on A1C reduction from baseline, both at week 26.
“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,” Dr. Pablo Lapuerta, Lexicon’s EVP and CMO, said in a statement.
“We look forward to the release of topline data from the remainder of the core Phase 3 sotagliflozin studies in T2D in early 2020,” he added.
