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COMPLETEDPhase 4NCT00123643

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.

Lead sponsor: St. Paul Heart Clinic•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

St. Paul Heart Clinic

Collaborators

GlaxoSmithKline

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.

Age

25 - 75 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 15, 2013Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment36

Start dateMay 2003

Last updatedJul 15, 2013

Condition

Type 2 Diabetes Mellitus

Locations shown

St. Paul Heart Clinic

Saint Paul, Minnesota

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2013Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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