Table 1 Comprehensive inclusion and exclusion criteria

Adults (aged ≥ 30 years)

T2D with HbA1c ≥ 6.0% and < 9.0%

Pre-existing CKD with

(i) 30 mL/min/1.73 m² ≤ eGFR < 60 mL/min/1.73 m² and/or

(ii) albuminuria ≥ 30 mg/g Cr

Patients with RHI < 2.10 at pre-testing RH-PAT within 3 mo prior to randomization

Patients who received an explanation of the study and provided written informed consent

Type 1 diabetes

History of clinically apparent atherosclerotic CVDs such as CAD, stroke, PAD, and

symptomatic carotid artery stenosis

History of arterial fibrillation

History of severe ketosis, diabetic coma, or precoma attack ≤ 6 mo prior to informed consent

Severe renal dysfunction (eGFR < 30 mL/min/1.73 m² or undergoing dialysis)

Patients received SGLT2is within 3 mo before informed consent

Patients who changed the glucose-lowering medications within 3 mo before informed consent

Hypersensitivity to ipragliflozin or other SGLT2is

Symptomatic hypotension, or systolic blood pressure < 90 mm Hg

Patients with severe infection or trauma at screening

Patients in perioperative period around screening

Polysystic kidney disease, lupus nephritis, or ANCA-related vasculitis

Pregnant or suspected pregnancy

Considered inappropriate for the study by investigators due to other reasons such as malignancy