Replication of the CANVAS Diabetes Trial in Healthcare Claims

Exclusion Criteria

• •History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
• •History of one or more severe hypoglycemic episode within 6 months before screening
• •Ongoing, inadequately controlled thyroid disorder.
• •Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant.
• •MI, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening, or a planned revascularization procedure, or history of New York Heart Association (NYHA) Class IV cardiac disease.
• •Findings on 12-lead electrocardiogram (ECG) that would require urgent diagnostic evaluation or intervention
• •History of hepatitis B surface antigen or hepatitis C antibody positive
• •Any history of or planned bariatric surgery.
• •History of malignancy within 5 years before screening
• •History of human immunodeficiency virus (HIV) antibody positive.
• •Subject has a current clinically important hematological disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia).
• •Major surgery (i.e., requiring general anesthesia) within 3 months of the screening visit or any surgery planned during the subject's expected participation in the study
• •Current use of other sodium glucose co-transporter 2 (SGLT2) inhibitor.
• •Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication