Secondary Analysis Shows Sotagliflozin Enhances Glucose Control in Type 2 Diabetes

Lexicon Pharmaceuticals, Inc. recently unveiled promising data from their SOTA-INS CGM Phase 3 randomized clinical trial at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain. The study explored the effects of sotagliflozin, a dual inhibitor of sodium-glucose cotransporter types 1 and 2 (SGLT1 and SGLT2), on continuous glucose monitoring (CGM) parameters in patients with type 2 diabetes (T2D) treated with basal insulin.

The trial evaluated the effectiveness of once-daily doses of sotagliflozin, specifically 400 mg and 200 mg, in improving time-in-range (TIR) for glucose levels between 70-180 mg/dL, a key metric recommended by the American Diabetes Association. The 400 mg dose showed significant improvements in TIR and other CGM parameters, such as glucose variability. The 200 mg dose also demonstrated positive trends, though to a lesser extent.

The primary endpoint of the study focused on the change in the percentage of time spent within the TIR. The results showed that both doses of sotagliflozin brought patients close to the ADA's recommended TIR target of at least 70%, with patients on the 400 mg dose achieving an average of 15.9 hours and those on the 200 mg dose achieving 15.3 hours within the target range. Additionally, the study observed modest reductions in time-above-range (TAR) and minor increases in time-below-range (TBR).

The data was presented by Dr. Julio Rosenstock, a Senior Scientific Advisor for Velocity Clinical Research and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center. Dr. Rosenstock highlighted the dual inhibition of SGLT1 and SGLT2 by sotagliflozin as a potential new therapeutic option for improving glycemic control in T2D patients on basal insulin therapy.

Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer, expressed optimism regarding the study's findings. While Lexicon is not pursuing an indication for treating T2D, Granowitz noted that the study adds valuable evidence supporting the therapeutic benefits of inhibiting SGLT1.

Sotagliflozin, discovered through Lexicon's advanced gene science techniques, inhibits two key proteins involved in glucose regulation. SGLT2 is primarily responsible for glucose and sodium reabsorption in the kidneys, while SGLT1 manages glucose and sodium absorption in the gastrointestinal tract. The drug has been evaluated in various patient populations, including those with heart failure, diabetes, and chronic kidney disease, involving approximately 20,000 patients in clinical trials.

Lexicon Pharmaceuticals is dedicated to developing innovative medicines that significantly improve patient lives. Through their Genome5000™ program, the company has studied the roles of nearly 5,000 genes to identify over 100 protein targets with substantial therapeutic potential. One of their key achievements is the commercial launch of INPEFA® (sotagliflozin) in the United States, with a promising pipeline of drug candidates for conditions such as neuropathic pain, diabetes, and metabolism.

The SOTA-INS CGM trial results underscore the potential of sotagliflozin as an adjunct therapy for improving glycemic control in T2D patients on insulin. While the company focuses on other indications, the trial adds to the growing body of evidence supporting the benefits of dual SGLT1 and SGLT2 inhibition.

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