Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
Information source: St. Paul Heart Clinic
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: rosiglitazone (Drug); glyburide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: St. Paul Heart Clinic Official(s) and/or principal investigator(s):
Alan J Bank, M.D., Principal Investigator, Affiliation: St. Paul Heart Clinic
Summary
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.
Clinical Details
Official title: Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients
Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Improvement in endothelial function
Secondary outcome: Improvement in markers of inflammation and oxidative stress
Detailed 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.
Eligibility
Minimum age: 25 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
St. Paul Heart Clinic, St. Paul, Minnesota 55102, United States
Additional Information
Starting date: May 2003
Ending date: December 2005
Last updated: April 10, 2007
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