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Use of Sodium–Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis

    Basic Details

    This study was designed to estimate real-world off-label use of sodium–glucose cotransporter 2 (SGLT2) inhibitors in patients with type 1 diabetes, estimate rates of diabetic ketoacidosis (DKA), and compare them with DKA rates observed in sotagliflozin clinical trials. This study identified initiators of SGLT2 inhibitors in the Sentinel system from March 2013 to June 2018, determined the prevalence of type 1 diabetes using a narrow and a broad definition, and measured rates of DKA using administrative claims data. Standardized incidence ratios (SIRs) were calculated using age- and sex-specific follow-up time in Sentinel and age- and sex-specific DKA rates from sotagliflozin trials 309, 310, and 312.


    Christian Hampp, Richard S. Swain, Casie Horgan, Elizabeth Dee, Yandong Qiang, Sarah K. Dutcher, Andrew Petrone, Rong Chen Tilney, Judith C. Maro, Catherine A. Panozzo

    Corresponding Author

    Christian Hampp, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration