A Study of Pioglitazone HCl Versus Glimepiride in Subjects With Type 2 Diabetes Measuring the Progression of Atherosclerosis (CHICAGO)
Information source: Takeda Global Research & Development Center, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2; Coronary Artery Disease
Intervention: Pioglitazone HCl (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Takeda Global Research & Development Center, Inc.
Summary
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.
Clinical Details
Official title: A Double-Blind, Randomized, Comparator-Controlled Study in Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl Versus Glimepiride on the Rate of Progression of Atherosclerotic Disease as Measured by Carotid Intima-Media Thickness
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Absolute change in carotid intima-media thickness (CIMT) from baseline to final visit (18 months).
Detailed description:
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
Minimum age: 45 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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%)
Locations and Contacts
Chicago, Illinois, United States
Additional Information
Starting date: August 2003
Ending date: April 2006
Last updated: February 16, 2007
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