A sub-analysis study of the prevention of atherosclerosis by SGLT2 inhibitor (a multicenter, randomized controlled study: PROTECT)
- Conditions
- Type2 diabetes
- Registration Number
- JPRN-jRCT1071220089
- Lead Sponsor
- ode Koichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 482
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Carotid artery intima-media thickness (IMT) after 24 months by treatment group
- Secondary Outcome Measures
Name Time Method