Sotagliflozin Added to Insulin Reduces the Risk of Clinically Important Hypoglycemic Events in Adults with Type 1 Diabetes Regardless of Kidney Function

Introduction and Objective: Chronic kidney disease (CKD) is a major risk factor for hypoglycemia. Sotagliflozin (SOTA) was associated with a reduced risk of hypoglycemia events when added to insulin in adults with type 1 diabetes (T1D). The present analysis evaluated the effect of kidney function on hypoglycemia in patients with T1D treated with SOTA. Methods: This analysis was conducted using pooled data of two placebo (PBO)-controlled trials of SOTA in combination with optimized insulin in adults with T1D. Documented hypoglycemia was predefined as blood glucose (BG) ≤70 and ≤55 mg/dL and severe hypoglycemia per Level 3 definition. Results were evaluated in the overall cohort and by eGFR subgroups (<60, 60 to <90, and ≥90 mL/min/1.73 m2). Results: Declining kidney function was associated with an increasing rate of severe hypoglycemic events and events with BG ≤ 70 or ≤ 55 mg/dL in the PBO group. Positively adjudicated severe hypoglycemia occurred in 7.4% of patients on PBO compared to 5.7% and 4.4% on SOTA 200 and 400 mg, respectively. A similar trend was observed across the eGFR. SOTA was associated with a reduction in the risk of events with BG ≤ 55 mg/dL, regardless of dose and eGFR subgroup (Table). Conclusion: SOTA significantly reduced the risk of clinically important BG events ≤55 and ≤70 mg/dL, with a trend towards a reduction in severe hypoglycemic events in patients with T1D regardless of baseline kidney function. Disclosure: M.B. Hardin: Employee; Lexicon Pharmaceuticals, Inc. A.K. Carroll: None. P.L. Banks: None. M. Girard: None. M.J. Davies: Employee; Lexicon Pharmaceuticals, Inc. Funding: Lexicon Pharmaceuticals