US-based biopharmaceutical company Lexicon has reported positive top-line results from its pivotal Phase III Tandem1 trial of sotagliflozin to treat type 1 diabetes on a background of optimised insulin.
Based on Lexicon's approach to gene science, sotagliflozin is developed as an orally administered dual inhibitor of two proteins considered responsible for glucose regulation, known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).
SGLT1 triggers glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose re-absorption by the kidney.
The double-blind, placebo controlled Phase III Tandem1 trial involved 793 patients with type 1 diabetes on an insulin pump or multiple daily injection therapy.
Insulin was optimised for all patients over six weeks to improve the glycemic control using insulin alone.
After the optimisation, the patients were maintained on optimised insulin and randomised to one of two doses of sotagliflozin or placebo with their baseline, post-optimisation A1C being tracked.
The three-arm trial tested sotagliflozin in two doses administered once on a daily basis before the first meal against placebo.
The trial met its primary endpoint suggesting a reduction in A1C after 24 weeks of the study, while demonstrating a general tolerability of sotagliflozin.
Sotagliflozin Type 1 Diabetes steering committee chairman USC clinical diabetes programmes director and Keck School of Medicine of USC professor of medicine Anne Peters said: “The inTandem1 study is part of the largest Phase III programme for an oral anti-diabetic agent in type 1 diabetes to date.
“Sotagliflozin demonstrated compelling, significant and clinically meaningful A1C reduction with no increase in severe hypoglycemia and a slight risk of DKA.
“If approved, sotagliflozin could represent a significant addition to the current standard of care and potentially allow patients with type 1 diabetes to better manage their diabetes while on insulin.”
The company is also undertaking another similar pivotal Phase III clinical trial of sotagliflozin to treat type 1 diabetes in Europe.