Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

This study has been completed.

First Received: July 21, 2005 Last Updated: April 10, 2007 History of Changes

Sponsor:	St. Paul Heart Clinic
Collaborator:	GlaxoSmithKline
Information provided by:	St. Paul Heart Clinic
ClinicalTrials.gov Identifier:	NCT00123643

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.

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

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glyburide Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by St. Paul Heart Clinic:

Primary Outcome Measures:

Improvement in endothelial function

Secondary Outcome Measures:

Improvement in markers of inflammation and oxidative stress

Estimated Enrollment:	40
Study Start Date:	May 2003
Estimated Study Completion Date:	December 2005

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

Ages Eligible for Study:	25 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123643

Locations

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

Sponsors and Collaborators

St. Paul Heart Clinic

GlaxoSmithKline

Investigators

Principal Investigator:

Alan J Bank, M.D.

St. Paul Heart Clinic

More Information

No publications provided

Study ID Numbers:	GSK2002-2
Study First Received:	July 21, 2005
Last Updated:	April 10, 2007
ClinicalTrials.gov Identifier:	NCT00123643 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Paul Heart Clinic:

thiazolidinedione
sulfonylurea
endothelial function

Additional relevant MeSH terms:

Glyburide
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010