The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: rosiglitazone and glyburide	Phase IV

Further Study Details: 

Primary Outcomes: Improvement in endothelial function
Secondary Outcomes: Improvement in markers of inflammation and oxidative stress
Expected Total Enrollment:  40

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.

Ages Eligible for Study:  25 Years   -   75 Years,  Genders Eligible for Study:  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 wks of Metformin 500 mg 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 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)
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00123643

Minnesota
      St. Paul Heart Clinic, St. Paul,  Minnesota,  55102,  United States; Recruiting

Study chairs or principal investigators

Alan J Bank, M.D.,  Principal Investigator,  St. Paul Heart Clinic   

Study ID Numbers:  GSK2002-2
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 22, 2005
ClinicalTrials.gov Identifier:  NCT00123643
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26