Not Signed In -
Glipizide and Metformin |
Metaglip |
Clinical Trial: Rosiglitazone versus Glipizide on Progression of Atherosclerosis in Patients with Cardiovascular Disease and Type 2 Diabetes
This study is currently recruiting patients.
|
Purpose
The purpose of this study is to test the safety and effectiveness of rosiglitazone against glipizide in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.
| Condition | Intervention | Phase |
|---|---|---|
| Non-Insulin-Dependent Diabetes Mellitus | Drug: Rosiglitazone Drug: Glipizide | Phase III |
MedlinePlus related topics: Diabetes
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone versus Glipizide on the Progression of Atherosclerosis in Subjects with Type 2 Diabetes Mellitus and Cardiovascular Disease
Further Study Details:
Primary Outcomes: Progression of atherosclerosis as measured by centrally assessed, intravascular ultrasound (IVUS)-derived change in percent of atheroma volume after 18 months
Secondary Outcomes: Assessments of other angiographic and IVUS-derived atherosclerotic endpoints; Glycemic parameters; Cardiovascular (CV) biomarkers and lipids; Medical care utilization questionnaires; Time to first occurrence and incidence of adjudicated major adverse coronary event
Expected Total Enrollment: 634
Secondary Outcomes: Assessments of other angiographic and IVUS-derived atherosclerotic endpoints; Glycemic parameters; Cardiovascular (CV) biomarkers and lipids; Medical care utilization questionnaires; Time to first occurrence and incidence of adjudicated major adverse coronary event
Expected Total Enrollment: 634
Study start: January 2005
Eligibility
Ages Eligible for Study: 30 Years - 80 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Patients with type 2 diabetes who are going to have a planned angioplasty for suspected or previously diagnosed cardiovascular disease or are undergoing an emergency percutaneous coronary intervention.
- Patients are allowed to have been previously controlled on diet, a single diabetic drug or a combination of two drugs at a low dose.
- General cardiac function should be good.
Exclusion Criteria:
- Receiving insulin therapy
- Congestive heart failure (CHF)
- Edema requiring medical treatment
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00116831
Alabama
Birmingham Heart Clinic, Birmingham, Alabama, 35235, United States; Recruiting
Robert Chadband 205-838-6281
Robert Chadband, Principal Investigator
Robert Chadband, Principal Investigator
California
Sacramento Research Medical Group, Sacramento, California, 95825, United States; Recruiting
David Ferrera 916-929-4646
David Ferrera, Principal Investigator
David Ferrera, Principal Investigator
LA Cardiology Associates, Los Angeles, California, 90017, United States; Recruiting
Ray Matthews 213-977-7436
Ray Matthews, Principal Investigator
Ray Matthews, Principal Investigator
Harbor UCLA, Torrance, California, 90502, United States; Recruiting
John Tayek 310-222-8015
John Tayek, Principal Investigator
John Tayek, Principal Investigator
Colorado
Kaiser Permanente, Englewood, Colorado, 80113, United States; Recruiting
William Georgitis 303-788-1064
William Georgitis, Principal Investigator
William Georgitis, Principal Investigator
District of Columbia
Washington Hospital Center, Washington, District of Columbia, 20010, United States; Recruiting
Michelle Magee 202-877-2384
Michelle Magee, Principal Investigator
Michelle Magee, Principal Investigator
Georgia
Fuqua Heart Center, Atlanta, Georgia, 30329, United States; Recruiting
David Robertson 404-605-5003
David Robertson, Principal Investigator
David Robertson, Principal Investigator
Illinois
Prairie Cardiovascular Consultants, Springfield, Illinois, 62707, United States; Recruiting
Tony DeMartini 217-544-6464 Ext. 66072
Tony DeMartini, Principal Investigator
Tony DeMartini, Principal Investigator
Indiana
The Care Group, LLC, Indianapolis, Indiana, 46290, United States; Recruiting
Michael Ball 317-338-6116
Michael Ball, Principal Investigator
Michael Ball, Principal Investigator
Maryland
John Hopkins Hospital, Baltimore, Maryland, 21287, United States; Recruiting
Todd Brown 410-502-0033
Todd Brown, Principal Investigator
Todd Brown, Principal Investigator
Massachusetts
Baystate Medical Center, Springfield, Massachusetts, 01199, United States; Recruiting
Burritt Haag 413-794-7031
Burritt Haag, Principal Investigator
Burritt Haag, Principal Investigator
New York
Albany Medical College, Albany, New York, 12208, United States; Recruiting
Mary Ellen Ehlers 518-262-6915
Mary Ellen Ehlers, Principal Investigator
Mary Ellen Ehlers, Principal Investigator
Ohio
Clinical Research Limited, Canton, Ohio, 44718, United States; Recruiting
Frederick Whittier 330-493-9765
Frederick Whittier, Principal Investigator
Frederick Whittier, Principal Investigator
Pennsylvania
Albert Einstein Medical Center, Philadelphia, Pennsylvania, 19141, United States; Recruiting
Arthur Chernoff 215-456-6141
Arthur Chernoff, Principal Investigator
Arthur Chernoff, Principal Investigator
Jeffrey Lins, Beaver, Pennsylvania, 15009, United States; Recruiting
Jeffrey Lins 724-728-3302
Jeffrey Lins, Principal Investigator
Jeffrey Lins, Principal Investigator
Heritage Cardiology Associates, Camp Hill, Pennsylvania, 17011, United States; Recruiting
Venkatesh Nadar 717-972-2829
Venkatesh Nadar, Principal Investigator
Venkatesh Nadar, Principal Investigator
Tennessee
Apex Cardiology, Jackson, Tennessee, 38301, United States; Recruiting
Lui Henry 731-423-8200
Lui Henry, Principal Investigator
Lui Henry, Principal Investigator
Texas
The Univ. of Texas Health Science Center, San Antonio, Texas, 78259, United States; Recruiting
Steven Bailey 210-567-6553
Steven Bailey, Principal Investigator
Steven Bailey, Principal Investigator
Washington
Overlake Internal Medicine Associates, Bellevue, Washington, 98004, United States; Recruiting
Marc Mitchell 425-450-6114
Marc Mitchell, Principal Investigator
Marc Mitchell, Principal Investigator
Study chairs or principal investigators
GSK Clinical Trials, Study Director, GlaxoSmithKline
More Information
Study ID Numbers: AVD100521
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 30, 2005
ClinicalTrials.gov Identifier: NCT00116831
Health Authority: United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medicinal Devices; Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2005-07-05
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 30, 2005
ClinicalTrials.gov Identifier: NCT00116831
Health Authority: United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medicinal Devices; Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2005-07-05
Resources
- Glipizide and Metformin (Drug Digest)
- Metaglip (Drug Digest)
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