Table 1 Detailed inclusion and exclusion criteria

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