Lexicon announces post-hoc analysis of clinical data on sotagliflozin

Lexicon (LXRX) Pharmaceuticals 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 was presented yesterday during the 85th Scientific Sessions of the American Diabetes Association 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 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 less than or equal to 70 mg/dL and less than or equal to 55 mg/dL, and severe hypoglycemia per the ADA Level 3 definition. Results were evaluated by subgroups defined by estimated glomerular filtration rate cut points: eGFR less than 60 ml/min/1.73m2, eGFR greater than or equal to 60 to less than 90 ml/min/1.73m2, and eGFR greater than or equal to 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 less than or equal to55 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.