Efficacy and Safety of Pioglitazone in Treating Subjects With Vascular Complications Associated With Type 2 Diabetes Mellitus.

Inclusion Criteria: * Females must be non-pregnant, non-lactating and post-menopausal. * A glycosylated hemoglobin level greater than 7.5% and less than 10%. * Has an age of onset of Type 2 Diabetes greater than 35 years of age. * Is on metformin monotherapy up to the maximum tolerated daily dose. * Has a normal or only slightly impaired renal function (a modification of diet in renal disease estimated glomerular filtration rate greater than 60 ml/min/1.73m2. * Antihypertensives, statins and any other hypolipidemic medications have been initiated at least three months prior to enrollment; no dose modifications are allowed during the study. * Has one or more cardiovascular comorbidities as follows: * stable angina pectoris * previous (greater than three months) transient ischemic attack, cerebrovascular accident or carotid atherosclerosis as assessed by bilateral carotid artery ultrasonography * peripheral vascular complications documented by a history of claudication or rest pain, ultrasonography or angiography. * and/or two or more of the following major cardiovascular risk factors: * hypertension (blood pressure \>130/80 mmHg or treatment) * dyslipidemia (low-density lipoprotein-cholesterol \>100 mg/dl or treatment and/or high-density lipoprotein-cholesterol \<40 mg/dl in men and \<45 mg/dl in women or treatment) * smoking (\>10 cigarettes/day) Exclusion Criteria: * Has Type 1 Diabetes. * Is on insulin therapy. * Is severely obese defined as a body mass index greater than or equal to 40mg/m2 * Has diabetic retinopathy. * Has evidence of hepatic dysfunction including liver transaminase greater than three times the upper limit of normal. * Is unable to remain on a stable dose of the following class of medications 30 days prior to randomization and throughout the six months of the study: * antihypertensives * statins * other hypolipidemic and antiplatelet drugs * Has a history of alcohol or other drug abuse. * Has had a new diagnosis of cancer or recurrent cancer within five years of screening. * Has a need for chronic (greater than two weeks) immunosuppressive therapy. * Has had heart failure based on the New York Heart Association Functional Class I through IV. * Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: * Other antidiabetic drugs (except metformin) * Fibrates * Rifampicin * Glibenclamide interacting drugs, including nonsteroidal anti-inflammatory agents * Other drugs that are highly protein bound, including: * sulphonamides * chloramphenicol * probenecid * monoamine oxidase inhibitors * fluoroquinolones antibiotics * oral miconazole * Has participated in another clinical study within the past three months.