Data Demonstrating Sotagliflozin Reduces the Risk of Clinically Important Hypoglycemic Events in Adults with Type 1 Diabetes When Added to Insulin Presented at the 85th Scientific Sessions of the American Diabetes Association (ADA)

Oral presentation highlighted the post-hoc analysis during the “Interventions to Prevent Hypoglycemia: Bench to Bedside” session

Treatment with sotagliflozin resulted in no increased risk and a reduction in hypoglycemia events, particularly in patients with blood glucose ≤55 mg/dL

THE WOODLANDS, Texas, June 23, 2025 (GLOBE NEWSWIRE) --  (Nasdaq: LXRX) announced that a post-hoc analysis of clinical study data showing a reduction in hypoglycemic events when sotagliflozin was added to optimized insulin therapy for people with type 1 diabetes (T1D) was presented yesterday during the 85th Scientific Sessions of the American Diabetes Association (ADA) in Chicago, Illinois.

The ADA emphasizes that hypoglycemia remains an important patient management issue in T1D. Its Standards of Care in Diabetes -- 2025 clinical update states, "Health care professionals should be vigilant in preventing hypoglycemia." In addition, severe hypoglycemia accounts for 5% of T1D hospitalizations and up to 10% of T1D deaths.

Chronic kidney disease (CKD) is an important, independent risk factor for hypoglycemia in people with T1D. Approximately 20% to 40% of people with T1D develop CKD. Treatment with sotagliflozin as an adjunct to insulin therapy has been shown to improve glycemic control while also reducing hypoglycemic events.

The aim of this post-hoc analysis was to evaluate the effect of kidney function on hypoglycemia risk in patients with T1D who were being treated with sotagliflozin, a dual inhibitor of SGLT 1 and 2, as an adjunct to optimized insulin therapy. Researchers analyzed pooled data from inTandem 1 and inTandem 2, identically designed 52-week Phase 3 clinical trials in which once-daily 200 mg and 400 mg doses of sotagliflozin were compared to placebo when added to optimized insulin therapy. In these studies, documented hypoglycemia was defined as blood glucose of ≤ 70 mg/dL and ≤ 55 mg/dL, and severe hypoglycemia per the ADA Level 3 definition.

Results were evaluated by subgroups defined by estimated glomerular filtration rate (eGFR) cut points: eGFR < 60 ml/min/1.73m², eGFR ≥ 60 to < 90 ml/min/1.73m², and eGFR ≥ 90 ml/min/1.73m². The overall trend favored sotagliflozin, indicating no increased risk and a reduction in hypoglycemia events, particularly in patients with blood glucose ≤55 mg/dL. Notably, the effect appears consistent across eGFR subgroups, suggesting that sotagliflozin maintains this similar trend regardless of kidney function. Treatment with sotagliflozin generally resulted in severe hypoglycemia event rates lower than that of placebo.

“This analysis is important because it demonstrated that adding sotagliflozin on top of optimized insulin therapy resulted in fewer people developing significant hypoglycemia,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “Practitioners recognize that hypoglycemia remains an obstacle to optimal care in people with diabetes.”

About Sotagliflozin

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.

About Lexicon Pharmaceuticals   

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications.  For additional information, please visit .   

Safe Harbor Statement  

This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin and its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.  

For Investor and Media Inquiries:  

Lisa DeFrancesco   

Lexicon Pharmaceuticals, Inc.