A sub-analysis study of the prevention of atherosclerosis by SGLT2 inhibitor (a multicenter, randomized controlled study: PROTECT)

JRCT ID: jRCT1071220089

Registered date:17/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type2 diabetes
• Date of first enrollment: 17/01/2023
• Target sample size: 482
• Study type: Observational

Outcome(s)

• Primary Outcome: Carotid artery intima-media thickness (IMT) after 24 months by treatment group

Secondary Outcome

1. Levels and changes from baseline after 24 months of the echocardiogram [LAVI, LVEF, LVMI, transmitral flow velocity pattern (E/A, DT), mitral annulus motion pattern (E/e'), the inferior vena cava diameter (IVCd)], flow mediated dilation(FMD), pulse wave velocity (PWV), cardio-ankle vascular index (CAVI), and pulse wave atherogenic index (AI) by treatment group
2. Levels and changes from baseline after 12 and 24 months of laboratory and blood test values (blood pressure, body weight, BMI, eEV, abdominal circumference, visceral and subcutaneous fat area (abdominal CT, only performed after 24 months), HbA1c (NGSP value), fasting blood sugar, serum lipids [TC, LDL-C (direct LDL-C), HDLC, TG, Non-HDL-C], AST, ALT, Fib4-Index,gamma-GTP, uric acid, serum creatinine, eGFR (corresponding value), hemoglobin, hematocrit, platelet count, ePV, and urinary albumin excretion (creatinine-corrected value) by treatment group
3. Levels and changes from baseline of specific blood biomarkers (high-sensitive CRP, MDA-LDL, NT-proBNP, and high-molecular-weight adiponectin) after 24 months

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Type 2 diabetes with HbA1c (NGSP) >=6.0% and less than10.0% despite diet/exercise therapy or diet/exercise therapy adding antidiabetic agents for over three months
2)over 20 years of age at the time of informed consent acquisition and hospitalization or outpatient
3) The patient provided with information about the study,submitted written informed consent to it

Exclude criteria

1) Type 1 diabetes
2) Has history of severe ketosis, diabetic coma, or precoma within 6 months
3) Has severe infection, serious trauma, or pre or post surgery (including carotid endarterectomy and stent implantation)
4) With severe renal dysfunction (eGRF <45 mL/min/1.73m2 or patient undergoing artificial dialysis)
5) Has history of myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage and transient ischemic attacks within 3 months before initiation of the study
6) Heart failure patient whose NYHA functional classification is III or IV
7) Has history of administration of SGLT-2 within 1 month before initiation of the study
8) Pregnant, possibly pregnant, planned to become pregnant or nursing women
9) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
10) Are considered not eligible for the study by the attending doctor due to other reasons

Related Information

• Primary Sponsor: Node Koichi