Lexicon Shows Sotagliflozin Cuts HbA1c, Weight and Hypoglycemia Events in CKD Subgroups
Post hoc analysis of 52-week trials showed 200 mg and 400 mg sotagliflozin reduced HbA1c, body weight, systolic blood pressure and insulin use in type 1 diabetics with eGFR ≥60 mL/min/1.73 m2, with less pronounced benefits in CKD Class 3A. It also cut hypoglycemia events without raising ketoacidosis risk and supports a 2026 NDA resubmission.
1. Study Design and Patient Cohorts
Lexicon analyzed pooled data from two 52-week placebo-controlled trials evaluating 200 mg and 400 mg doses of sotagliflozin added to optimized insulin in type 1 diabetes patients. Participants were grouped by eGFR: ≥90 (CKD Class 1), 60–<90 (CKD Class 2) and 45–<60 mL/min/1.73 m2 (CKD Class 3A).
2. Efficacy Outcomes by Kidney Function
Both sotagliflozin doses produced significant reductions in HbA1c, body weight, systolic blood pressure and total insulin use compared to placebo in CKD Class 1 and 2 groups, while benefits were attenuated in CKD Class 3A patients, indicating renal function impacts treatment magnitude.
3. Safety Profile and Regulatory Pathway
Sotagliflozin lowered incidence of hypoglycemia events (glucose ≤55 mg/dL) across all kidney function subgroups without showing increased diabetic ketoacidosis. These findings support Lexicon’s plan to resubmit the NDA for type 1 diabetes in 2026 based on FDA feedback.