LAUSR

In most patients with T1D, adequate glycemic control is not achieved with insulin therapy alone, and intensifying insulin therapy can increase the risk of hypoglycemia. Sotagliflozin (SOTA) is a dual SGLT1 and SGLT2 inhibitor, which blunts and delays postprandial hyperglycemia and reduces renal glucose reabsorption. In two 52 weeks phase 3 studies adults with T1D were randomized 1:1:1 to placebo + insulin (PBO), SOTA 200 mg + insulin or SOTA 400 mg + insulin, once daily, after 6 weeks of insulin therapy optimization. HbA1c change over 52 weeks, along with change of daily insulin dose and safety, were assessed using a pooled analysis. Significant HbA1c reductions were observed with SOTA 200 or 400 vs. PBO at week 24 and sustained to 52 weeks, with a concomitant decrease in total daily insulin dose, mainly due to reduction in bolus insulin (BI), as 70-80% of the total insulin reduction was from BI for both SOTA doses. At 52 weeks, patients in SOTA groups had a lower incidence of severe hypo (SH) but more genital mycotic infections, DKA and diarrhea than PBO. In conclusion, SOTA demonstrated additional and sustained reduction of HbA1c on top of optimized insulin while reducing total daily insulin dose (mainly BI doses), with less incidence of SH. This may be an additional therapy for patients with T1D without good glycemic control despite optimized insulin therapy. Disclosure J. Pettus: Advisory Panel; Self; Sanofi, Novo Nordisk Inc.. Consultant; Self; MannKind Corporation. Advisory Panel; Self; Insulet Corporation. Consultant; Self; Senseonics. S.A. Weinzimer: Speaker9s Bureau; Self; Medtronic MiniMed, Inc., Insulet Corporation. Consultant; Self; Sanofi. Stock/Shareholder; Self; InsuLine Medical Ltd. R.J. Mccrimmon: Advisory Panel; Self; Novo Nordisk Foundation, Sanofi-Aventis. Research Support; Self; The Leona M. and Harry B. Helmsley Charitable Trust, Diabetes UK. Other Relationship; Self; Elsevier. F. Ampudia Blasco: Advisory Panel; Self; Abbott, Eli Lilly and Company, GlaxoSmithKline plc., LifeScan, Inc., Medtronic, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Pfizer Inc., Sanofi-Aventis. J.A. Stewart: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. P. Strumph: Employee; Self; Lexicon Pharmaceuticals, Inc.. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc.. Board Member; Self; College Diabetes Network. J.H. Oliveira: Employee; Self; Sanofi RD Spouse/Partner; Eli Lilly and Company. P. Lapuerta: Employee; Self; Lexicon Pharmaceuticals, Inc.. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc., Merck & Co., Inc. R. Castro: Employee; Self; Sanofi US.