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 (eGFRÂ <Â 45Â mL/min/1.73Â 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 <90Â 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 1Â 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 |