Published Data in Journal of American Society of Nephrology Highlights Findings on Efficacy and Safety of Sotagliflozin for People With Type 1 Diabetes and Chronic Kidney Disease

Core Insights - The study published in the Journal of American Society of Nephrology indicates that sotagliflozin, when added to insulin, effectively lowers glycated hemoglobin (HbA1c) in patients with type 1 diabetes (T1D) and chronic kidney disease (CKD) similarly to those without CKD [1][2] - Sotagliflozin shows a lower to neutral risk of severe hypoglycemia and does not significantly increase the risk of diabetic ketoacidosis (DKA) [1][2] Study Findings - The research utilized data from the 52-week inTandem1 and 2 trials and the 24-week inTandem3 trial to evaluate the effects of sotagliflozin (200mg or 400mg daily) versus placebo on HbA1c, body weight, systolic blood pressure, insulin dose, and safety endpoints [3] - In the inTandem1 and 2 trials, 237 out of 1,575 patients had CKD, while 228 out of 1,402 patients in the inTandem3 trial had CKD [4] - At week 24, significant placebo-adjusted reductions in HbA1c were observed in both CKD and non-CKD subgroups, with reductions of -0.4% for both 200mg and 400mg doses in the non-CKD subgroup and -0.4% and -0.3% in the CKD subgroup [5] - The incidence of severe hypoglycemia at week 52 was lower in the CKD subgroup receiving sotagliflozin (7% for 200mg and 4% for 400mg) compared to placebo (17%) [5] - The incidence of adjudicated DKA at week 52 in the CKD subgroup was 1%, 5%, and 3% for placebo, 200mg, and 400mg doses, respectively [5] Additional Insights - The study co-author emphasized the urgent need for new treatment options for patients with T1D and CKD, highlighting that sotagliflozin could provide significant benefits if approved by the FDA [7] - The FDA has set a target action date of December 20, 2024, for the approval of ZynquistaTM (sotagliflozin) [8] - Sotagliflozin is an oral inhibitor of SGLT1 and SGLT2, which are responsible for glucose regulation, and has been studied in various patient populations, including approximately 20,000 patients across multiple clinical studies [8]