Primary prevention of cerebrovascular and cardiovascular events with an oral antidiabetic agent in patients with type 2 diabetes at high risk for cerebral infarctio
Not Applicable
- Conditions
- Type 2 Diabetes
- Registration Number
- JPRN-UMIN000000846
- Lead Sponsor
- PROFIT-J Study Steering Committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
1 Current or past history of heart failure 2 History of treatment with a thiazolidine derivative within 8 weeks 3 Severe liver dysfunction:ALT>= 100 or viral hepatitis 4 Severe renal dysfunction:Cr>=2.5 5 Concerns about safety of a thiazolidine derivative 6 Concerns about safety of drugs to be studied 7 Cerebral hemorrhage 8 Manifest dementia 9 History of documented myocardial infarction or angina prior to registration 10 Those whom the principle investigators or other investigators consider unsuitable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite endpoints: overall death + stroke + myocardial infarction (Kaplan Meier method).
- Secondary Outcome Measures
Name Time Method Incidence of cerebral infarction (Kaplan Meier method) Incidence of cerebral infarction + TIA Incidence of cardiovascular events (myocardial infarction + angina + PCI/CABG) Incidence of acute coronary syndromes Albuminuria (absolute value and progression determined according to the stage of nephropathy) Cerebrovascular events categorized as ischemic or vascular and specific disease: secondary endpoint Index related to blood glucose: HbA1c Blood pressure: SBP and DBP Serum lipids: LDL, HDL, TG Cognitive function and depression: MMSE, Hasegawa Dementia Scale Revised (HDSR) Japan Stroke Scale - Depression Scale (JSS-D) only in institutes that can give this test Safety: hypoglycemia, edema, heart failure, liver function