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Table 1 Detailed inclusion and exclusion criteria

From: Rationale and design of a multicenter randomized controlled study to evaluate the preventive effect of ipragliflozin on carotid atherosclerosis: the PROTECT study

Inclusion Exclusion
Adults (aged ≥20 years) Type 1 diabetes mellitus
T2DM with 6.0 % ≤ HbA1c < 10.0 % despite diet and exercise therapy and/or the standard medications for at least 3 months prior to randomization History of severe ketosis, diabetic coma, or
The patient provided written informed consent to participate in the study Precoma attack ≤6 months prior to informed consent
  Patients with severe infection or trauma at trial screening
Patients in perioperative period around trial screening
Severe renal dysfunction (eGFR < 45 ml/min/1.73 m2) or patients receiving dialysis
History of coronary artery disease, coronary vascularization, open-heart surgery, stroke, or transient ischemic attack ≤3 months prior to eligibility
CHF (NYHA functional classification III and IV)
History of administration of SGLT2 inhibitor 1 month prior to study initiation
Pregnant or suspected pregnancy in females
Lactating female
History of hypersensitivity to ingredients of ipragliflozin
Considered inappropriate for the study by investigators due to other reasons, such as malignancy
  1. CHF chronic heart failure, eGFR estimated glomerular filtration rate, NYHA New York Heart Association, SGLT2 sodium glucose cotransporter 2, T2DM type 2 diabetes mellitus