Table 1.

Detailed inclusion and exclusion criteria

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

CHF chronic heart failure, eGFR estimated glomerular filtration rate, NYHA New York Heart Association, SGLT2 sodium glucose cotransporter 2, T2DM type 2 diabetes mellitus