Expired Study
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St. Paul, Minnesota 55102


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

GSK2002-2


NCT ID:

NCT00123643


Secondary ID:


Study Acronym:


Brief Title:

Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients


Official Title:

Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

25 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

St. Paul Heart Clinic


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:May 2003
Completion Date:December 2005
Verification Date:April 2007
Last Changed Date:April 10, 2007
First Received Date:July 21, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Improvement in markers of inflammation and oxidative stress
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Improvement in endothelial function
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:rosiglitazone
Intervention Type:Drug
Name:glyburide

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:St. Paul Heart Clinic
Agency Class:Industry
Agency Type:Collaborator
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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