Primary prevention of cerebrovascular and cardiovascular events with an oral antidiabetic agent in patients with type 2 diabetes at high risk for cerebral infarction

UMIN ID: UMIN000000846

Registered date:09/10/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Type 2 Diabetes
• Date of first enrollment: 2007/09/01
• Target sample size: 500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Pioglitazone (15-45 mg/day)
An oral diabetic drug other than pioglitazone.

Outcome(s)

• Primary Outcome: Composite endpoints: overall death + stroke + myocardial infarction (Kaplan Meier method).
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 55years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: PROFIT-J Study Steering Committee
• Source(s) of Monetary Support: Japan Cardiovascular Research Foundation