Consistency of Glycemic Improvement with Sotagliflozin across Key Subgroups in Adults with Type 1 Diabetes: Pooled Analysis from inTandem Trials

Introduction and Objective: Sotagliflozin (SOTA) demonstrated reductions in A1C as an oral adjunct to insulin in adults with type 1 diabetes (T1D). Understanding the consistency of effect across clinically relevant subgroups is important to inform individualized therapeutic decision-making. This analysis evaluated the robustness of glycemic efficacy with SOTA across prespecified subgroups. Methods: Subgroups were evaluated using a pooled patient-level analysis of the inTandem 1 and 2 trials. In these trials, adults with T1D received either once-daily SOTA 200 mg (N = 524), 400 mg (N = 525), or placebo (PBO; N = 526) added to optimized insulin therapy. Difference in least squares (LS) mean change from baseline to Week 24 in A1C was estimated using a mixed models for repeated measures across prespecified subgroups. Results: From a mean baseline A1C of ~7.7%, SOTA 200 mg and 400 mg significantly reduced A1C versus PBO by 0.4%. The effect of SOTA on A1C by subgroups was generally consistent with that in the overall cohort (Figure). As expected, numerically greater A1C reductions were seen in participants with higher baseline levels (>8.5%) and efficacy appeared to attenuate in those with reduced eGFR (<60 mL/min/1.73 m2). Conclusion: Treatment with SOTA demonstrated consistent reductions in A1C across various subgroups of adults with T1D, highlighting the potential role of SOTA as an adjunctive oral therapy to insulin in a broad patient population. Disclosure: M.B. Hardin: Employee; Current; Lexicon Pharmaceuticals, Inc. M. Girard: None. P. Banks: Employee; Current; Lexicon Pharmaceuticals, Inc. M.J. Davies: Employee; Current; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Current; Lexicon Pharmaceuticals, Inc.