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Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors & Diabetic Ketoacidosis (DKA) and Use in Type 1 Diabetes Mellitus (T1DM)

    Basic Details
    Last Updated
    Thursday, February 15, 2024
    Original Posting Date
    Health Outcome(s)
    diabetic ketoacidosis (DKA)
    use in type 1 diabetes mellitus (T1DM)
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    In response to clinical trials showing an increased risk of DKA with sotagliflozin in T1DM, FDA assessed off-label use of SGLT2 inhibitors (approved for use in T2DM) and real-world rates of DKA when used in patients with T1DM. Elevated rates of DKA with off label SGLT2 inhibitor use among patients with T1DM were seen compared to clinical trials. These findings were presented at the Advisory Committee meeting for sotagliflozin, and this helped inform the committee member discussion on the benefit-risk assessment.