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Table 1 Comprehensive inclusion and exclusion criteria

From: Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial

Inclusion Exclusion
Adults (aged ≥20 years) Type 1 diabetes mellitus
T2DM with HbA1c ≥6.0% and <10.0%, unchanged dosage of glucose-lowering agent(s) within 1 month before consent is provided, investigator considers the patient can start or add/switch to the trial drug History of diabetic ketoacidosis or diabetic coma within the last 6 months
Severe renal dysfunction (eGFR < 45 mL/min/1.73 m2 or undergoing dialysis)
Patients with at least one of the following conditions: Serious liver dysfunction (AST or ALT is 3 times higher than site reference value)
 CHF (NYHA classification I–III, systolic or diastolic failure) not changed NYHA classification and receiving unchanged heart failure medication within 1 month before consent is provided
CHF (NYHA classification IV)
Hypotension (systolic blood pressure <90 mmHg)
Pituitary gland dysfunction or adrenal gland dysfunction
 History of CAD (myocardial infarction and angina) or cerebral infarction History of CAD, cerebrovascular disease, or TIA within 3 months before consent
 Previous coronary revascularization (PCI and CABG) History of coronary revascularization (PCI and CABG) within 3 months before consent
 Presence of coronary artery stenosis ≥50% luminal narrowing depicted by angiography or MSCT
Patients received SGLT2 inhibitor within 1 month before consent
 Diagnosis of arteriosclerosis obliterans
Patients who received an explanation of the study and provided written informed consent Pregnant or suspected pregnancy
Lactating
History of hypersensitivity to ingredients of empagliflozin
Considered inappropriate for the study by investigators due to other reasons, such as malignant complications
  1. ALT alanine aminotransferase, AST aspartate aminotransferase, CABG coronary artery bypass grafting, CAD coronary artery disease, CHF chronic heart failure, eGFR estimated glomerular filtration rate, MSCT multi-slice computed tomography, NYHA New York Heart Association, PCI percutaneous coronary intervention, SGLT2 sodium glucose cotransporter 2, TIA transient ischemic attack, T2DM type 2 diabetes mellitus