CHICAGO.

Trial name or title	A Study of Pioglitazone HCl Versus Glimepiride in Subjects With Type 2 Diabetes Measuring the Progression of Atherosclerosis (CHICAGO)
Methods
Participants	Study subjects will be treated with either pioglitazone or glimepiride for approximately 72 weeks (18 months). Subjects will make 12 or 13 visits to the study center, 4 visits to the center conducting the carotid ultrasound, and 2 visits to the center conducting the electron beam tomography scan. During visits to the study center, subjects will have blood drawn at each visit, have urine collected at 5 visits, have their vital signs and abdominal and hip girth measured at each visit, have 3 physical exams over the course of the study, and have an ECG at the beginning and end of the study. At each visit, information will be collected regarding adverse events the subject may have experienced and any medications the subject is taking. Eligibility: Ages Eligible for Study: 45 Years ‐ 85 Years, Genders Eligible for Study: Both Inclusion Criteria: ‐ Subjects aged 45 to 85 years, inclusive. ‐ Subjects with type 2 diabetes. ‐ Subjects with HbA1c >6.0% and <9% if taking antidiabetic medications, or HbA1c >6.5% and <10% if not taking antidiabetic medication. Exclusion Criteria: ‐ Subjects with type 1 diabetes, symptomatic CAD, cerebrovascular disease or peripheral vascular disease. ‐ Subjects taking more than two antidiabetic therapies. ‐ Subjects taking thiazolidinediones (TZDs) currently or in the past 12 weeks ‐ Subjects with New York Heart Association Class III or IV cardiac failure or left ventricular dysfunction (left ventricular ejection fraction <40%)
Interventions	Study Design: Treatment, Randomized, Double‐Blind, Active Control, Parallel Assignment, Efficacy Study Study subjects will be treated with either pioglitazone or glimepiride for approximately 72 weeks (18 months).
Outcomes	Primary Outcomes: Absolute change in carotid intima‐media thickness (CIMT) from baseline to final visit (18 months).
Starting date	Study start: August 2003; Study completion: October 2006 Last follow‐up: April 2006; Data entry closure: July 2006
Contact information	Takeda Global Research & Development Center, Inc ClinicalTrials.gov Identifier: NCT00225264
Notes	The primary purpose of this study is to compare the effects of pioglitazone HCl versus glimepiride on the amount of thickening of the carotid artery, a large vessel in the neck. The carotid artery is measured using a noninvasive procedure called an ultrasound. It is believed that the amount of thickness of the carotid artery can be an indication of the amount of atherosclerosis or heart disease that a person has.