Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients...
Brief Summary
Official Title: “Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients”
The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Detailed Clinical Trial Description
Rosiglitazone and glyburide are two commonly used diabetic medications that have both been shown to be effective in controlling blood glucose levels. Since they work in different ways, they may have different effects on the health of the blood vessels. This study will assess which medication is better at improving the health of the arteries separate from the blood glucose lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.
Intervention(s) in this Clinical Trial
- Drug: rosiglitazone
- Drug: glyburide
Outcome Measures for this Clinical Trial
Primary Measures
- Improvement in endothelial function
Secondary Measures
- Improvement in markers of inflammation and oxidative stress
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Age 25-75 years
- Type 2 diabetes mellitus for less than or equal to 10 years
- Pre-screening HbA1c > 6.5 %
- Screening 110 mg/dl < fasting plasma glucose < 240 mg/dl after 2 weeks of metformin 500 mg twice daily (b.i.d.)
Exclusion Criteria:
- Thiazolidinedione or sulfonylurea use in previous 30 days (may undergo washout period of 30 days)
- Known contraindications to use of thiazolidinedione or sulfonylurea
- Female patients must be postmenopausal, surgically sterile, or using adequate contraception
- Uncontrolled hyperlipidemia according to American Heart Association (AHA) guidelines
- Subcutaneous insulin use
- Elevated liver enzymes (2.5 times the upper limit of the reference range)
- Serum creatinine >160 mmol/l
- Anemia (Hb <11 g/dl for men or <10 g/dl for women)
- Body mass index (BMI) <22 or >42 kg/m2
- History of ketoacidosis
- Angina/New York Health Academy class III/IV cardiac insufficiency
- Electrocardiographic evidence of marked left ventricular hypertrophy
- Uncontrolled hypertension according to AHA guidelines
- Hemoglobinopathy
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 25 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: St. Paul Heart Clinic Other
Overall Clinical Trial Officials and Contacts
Alan J Bank, M.D. Principal Investigator St. Paul Heart Clinic
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00123643
Study ID Number: GSK2002-2
ClinicalTrials.gov Identifier: NCT00123643
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00123643
