Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
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ClinicalTrials.gov Identifier: NCT00123643
: July 25, 2005
Results First Posted
: August 9, 2012
Last Update Posted
: July 15, 2013
St. Paul Heart Clinic
Information provided by (Responsible Party):
Aaron S. Kelly, Ph.D., University of Minnesota - Clinical and Translational Science Institute
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.
Condition or disease
Type 2 Diabetes Mellitus
Drug: rosiglitazoneDrug: glyburide
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.
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Ages Eligible for Study:
25 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.)
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