Lexicon Pharmaceuticals announced that a post-hoc analysis of clinical study data showing a reduction in hypoglycaemic events when sotagliflozin was added to optimized insulin therapy for people with type 1 diabetes (T1D) was presented during the 85th Scientific Sessions of the American Diabetes Association (ADA) in Chicago, Illinois recently.
The ADA emphasizes that hypoglycaemia 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 hypoglycaemia.” In addition, severe hypoglycaemia accounts for 5% of T1D hospitalisations and up to 10% of T1D deaths.
Chronic kidney disease (CKD) is an important, independent risk factor for hypoglycaemia 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 glycaemic control while also reducing hypoglycaemic events.
The aim of this post-hoc analysis was to evaluate the effect of kidney function on hypoglycaemia 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 analysed 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 hypoglycaemia was defined as blood glucose of ≤ 70 mg/dL and ≤ 55 mg/dL, and severe hypoglycaemia 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 favoured sotagliflozin, indicating no increased risk and a reduction in hypoglycaemia 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 hypoglycaemia event rates lower than that of placebo.
About Sotagliflozin
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, pioneering medicines. Lexicon is leading the discovery and development of innovative medicines to treat disease safely and effectively.
