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

INTERVENTION: Pioglitazone (15‐45 mg/day) An oral diabetic drug other than pioglitazone. CONDITION: Type 2 Diabetes 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 INCLUSION CRITERIA: Patients diagnosed as having type 2 diabetes and whosatisfy one of the following criteria 1 Asymptomatic cerebral infarction evident on MRI. 2 Mean IMT=>1mm (far wall, either right or left) 3 Albuminuria>=100µg/mg creatinine (spot urine sample) HbA1C<=10% Concomitant hypertension or hyperlipidemia