Rosiglitazone Therapy In The Prevention Of Coronary Artery Disease In Patients With Impaired Glucose Tolerance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Denver Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Denver Research Institute
ClinicalTrials.gov Identifier:
NCT00733174
First received: August 8, 2008
Last updated: August 11, 2008
Last verified: August 2008
  Purpose

Subjects with impaired glucose tolerance will be randomized to either rosiglitazone or placebo for a 18 month period. The study will look at baseline, 12 month and 18 month data for exercise tolerance, coronary artery calcification and diabetes indicators.


Condition Intervention Phase
Impaired Glucose Tolerance
Drug: Rosiglitazone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rosiglitazone Therapy In The Prevention Of Coronary Artery Disease In Patients With Impaired Glucose Tolerance

Resource links provided by NLM:


Further study details as provided by Denver Research Institute:

Primary Outcome Measures:
  • Effect of rosiglitazone vs. placebo on exercise tolerance [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2004
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rosiglitazone
Drug: Rosiglitazone
tablet
Placebo Comparator: 2
Placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must sign the informed consent to participate in the study.
  • Male or female adults ages 25-75 years.
  • Female subjects must be postmenopausal (i.e., > 6 months without menstrual period), surgically sterile, or using effective barrier contraceptive measures (Intra-Uterine Device (IUD), diaphragm with spermicide or condom with spermicide).
  • Women of childbearing potential must use effective barrier contraceptive measures for at least 1 month prior to visit 1, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication.
  • Female subjects of childbearing potential must have a negative urine pregnancy test.
  • Subjects must have an FPG < 126 mg/dL at Screening 1 AND Screening 2, a C-peptide > 2.0 ng/mL and a HbA1c <6.5%.
  • Subjects must have a Body Mass Index 25-40 (must be < 300 lbs).
  • Subjects must have a 2 hour post-prandial glucose 140-199 mg/dL at Screening 1 AND Screening 2. If the 2 hour post-prandial glucose result is 130-139 mg/dL at Screening 2, subjects will be allowed to repeat the OGTT.

Exclusion Criteria:

  • Women who are lactating, pregnant, or planning to become pregnant during the study will be excluded.
  • Women using hormone contraception or on hormone replacement therapy will be excluded.
  • Subjects with any clinically significant abnormality identified on the Screening physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study will also be excluded.
  • Use of any other investigational agents or participation in any other investigational studies during the study period will not be allowed.
  • Patients will also be excluded if there is a presence of clinically significant hepatic disease or patient with LFT levels > 2 times the upper limit of normal laboratory range
  • Subjects with a documented history of significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to thiazolidinediones
  • Subjects with any contraindications to rosiglitazone
  • Presence of unstable or severe (New York Heart Association-NYHA class 3 or 4) angina, including angina requiring continual nitrate treatment for symptomatic relief, or coronary insufficiency
  • Subjects with HYHA class 3 or 4 of congestive heart failure requiring drug therapy; systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg
  • History of cancer (except non-melanomatous skin carcinoma)
  • Active alcohol or drug abuse within the last 6 months
  • Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids
  • Subjects who are unable to understand dosing directions or swallow study medications
  • Subjects who are currently smoking
  • Subjects unable to adhere to protocol requirements.
  • Persons with angina or any other cardiac or pulmonary symptoms that would potentially limit exercise performance will be excluded.
  • Persons taking prescription or over-the-counter weight loss medications or persons on a weight loss program with ongoing weight loss, or starting an intensive exercise program within 30 days of screening will also be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733174

Contacts
Contact: Stacey Mitchell, BSN, RN 303-399-8020 ext 2059 stacey.mitchell@va.gov

Locations
United States, Colorado
South Federal Family Practice Recruiting
Denver, Colorado, United States, 80219
Contact: Annette Grissett, MA    303-934-2202    annetteg@roydurbin.com   
Contact: Stacey Mitchell, BSN, RN    303-399-8020 ext 2059    stacey.mitchell@va.gov   
Sponsors and Collaborators
Denver Research Institute
GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Jane Reusch, MD, Denver Research Institute
ClinicalTrials.gov Identifier: NCT00733174     History of Changes
Other Study ID Numbers: 101797, COMIRB NO: 03-755
Study First Received: August 8, 2008
Last Updated: August 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Research Institute:
IGT

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Intolerance
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014