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Table 1 Comprehensive inclusion and exclusion criteria

From: Rationale and design of an investigator-initiated, multicenter, prospective open-label, randomized trial to evaluate the effect of ipragliflozin on endothelial dysfunction in type 2 diabetes and chronic kidney disease: the PROCEED trial



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

  1. ANCA antineutrophil cytoplasmic antibody; CAD coronary artery disease; CVDs cardiovascular diseases; CKD chronic kidney disease; eGFR estimated glomerular filtration rate; PAD peripheral artery disease; RHI reactive hyperemia index; RH-PAT reactive hyperemia peripheral arterial tonometry; SGLT2is sodium glucose cotransporter 2 inhibitors; TIA transient ischemic attack; T2D type 2 diabetes