Efficacy of Pioglitazone on Macrovascular Outcome in Patients With Type 2 Diabetes

Inclusion Criteria * Type 2 diabetes mellitus * Glycosylated hemoglobin above the upper limit of normal (ie, the local equivalent of 6.5% for) * Established history of macrovascular disease, defined as 1 or more of: * Myocardial infarction at least 6 months before entry into the study. * Stroke at least 6 months before entry into the study * Percutaneous coronary intervention or coronary artery bypass graft at least 6 months before entry into the study. * Acute coronary syndrome at least 3 months before entry into the study. * Objective evidence of coronary artery disease. * Peripheral arterial obstructive disease Exclusion Criteria * Signs of type 1 diabetes. * Patients prescribed insulin as sole therapy for glycemic control of diabetes for 2 weeks or more at any time in the previous 3 months. * Myocardial infarction, stroke, coronary artery bypass graft, or percutaneous cardiac intervention in the 6 months prior to enrolment. * Acute coronary syndrome in the 3 months prior to enrolment. * Heart failure at entry defined as patient having a New York Heart Association functional score of II or above. * Had an appointment for a coronary angiogram or endovascular or surgical intervention. * Leg ulcers, gangrene, or ischemic rest pain. * Had an appointment for an angiogram or endovascular or surgical intervention for leg ischemia. * Had undergone a major operation (defined as a surgical procedure lasting for more than 30 minutes) at any time in the previous 4 weeks. * Significantly impaired hepatic function, defined as alanine aminotransferase greater than 2.5 times the upper limit of normal. * Familial polyposis coli. * Required dialysis. * History of alcohol or drug abuse. * Any other intercurrent disease believed to be likely to have a significant impact on the patient's life expectancy during the course of the study (eg, cancer). * Patient was undergoing follow-up as part of another clinical trial or less than 3 months had elapsed since the last dose of an investigational drug or procedure. * Hypersensitivity to pioglitazone or other TZD. * Current use of pioglitazone or other TZD. * Patient was known to be infected with human immunodeficiency virus or was known to have viral hepatitis. * Women who were any of the following: pregnant, breast feeding, wished to become pregnant during the course of the study or of childbearing potential and not planning to use a reliable method of contraception throughout the study.