Lexicon Pharmaceuticals Says sotagliflozin Improves Cardiometabolic Outcomes In Type 1 Diabetes Regardless Of Kidney Function; New Analysis To Be Presented At ATTD 2026

- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that results of a post hoc analysis of clinical data evaluating the impact of kidney function on the long-term efficacy and safety of sotagliflozin on people with type 1 diabetes will be delivered as a short oral presentation tomorrow, March 12, during the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). The congress is being held March 11-14, 2026, in Barcelona, Spain.

"Recognizing that a patient's kidney function can impact the efficacy of SGLT inhibitors, we conducted this post hoc analysis of clinical data from two identically-designed trials in patients with type 1 diabetes and were encouraged to find that treatment with sotagliflozin resulted in improvements in multiple efficacy measures after one year in both those with normal kidney function and those with mildly reduced kidney function," said Craig Granowitz, M.D., Ph.D., Lexicon's senior vice president and chief medical officer. "Not only was sotagliflozin shown to improve cardiometabolic parameters in this patient population, but it also reduced clinically important hypoglycemia events, which are a leading cause of acute mortality and morbidity and can be life-threatening."

Using pooled data from two 52-week, placebo-controlled trials of 200 mg or 400 mg doses of sotagliflozin added to optimized insulin, investigators compared the efficacy (as measured by HbA1c, body weight and systolic blood pressure) and safety (as measured by hypoglycemia and diabetic ketoacidosis) of 200 mg or 400 mg doses of sotagliflozin as compared to the placebo treatment arms in such studies, subgrouped by estimated glomerular filtration rates (eGFR, a measure of kidney function) of 45 to <60 (chronic kidney disease [CKD] Class 3A), 60 to <90 (CKD Class 2), and ≥90 mL/min/1.73m2 (CKD Class 1).

Results showed that both doses of sotagliflozin significantly decreased HbA1c, body weight, systolic blood pressure and total insulin use compared to placebo after 52 weeks in patients with CKD Class 1 and 2. These positive effects with sotagliflozin were not as pronounced in patients with CKD Class 3A. Additionally, sotagliflozin reduced events of blood glucose ≤55 mg/dL (3 mmol/L) regardless of patients' kidney function. Results did not show a trend toward increased incidence of diabetic ketoacidosis based on patients' kidney function.

Lexicon remains on track to resubmit the New Drug Application (NDA) for ZYNQUISTA® (sotagliflozin) glycemic control in patients with type 1 diabetes in 2026 based upon U.S. Food and Drug Administration (FDA) feedback and additional clinical data received to date from the STENO1 study (Clinicaltrials.gov: NCT06082063). STENO1 is a third-party funded, investigator-initiated study of sotagliflozin and other agents being conducted by the Steno Diabetes Center in Denmark.