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Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT00123643
Recruitment Status : Completed
First Posted : July 25, 2005
Results First Posted : August 9, 2012
Last Update Posted : July 15, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Aaron S. Kelly, Ph.D., University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
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 Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: rosiglitazone Drug: glyburide Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients
Study Start Date : May 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rosiglitazone Drug: rosiglitazone
Active Comparator: Glyburide Drug: glyburide



Primary Outcome Measures :
  1. Flow Mediated Dilation [ Time Frame: change from baseline to 6 months ]
    Measure of endothelial function



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Aaron S. Kelly, Ph.D., Assistant Professor, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00123643     History of Changes
Other Study ID Numbers: GSK2002-2
First Posted: July 25, 2005    Key Record Dates
Results First Posted: August 9, 2012
Last Update Posted: July 15, 2013
Last Verified: June 2013

Keywords provided by Aaron S. Kelly, Ph.D., University of Minnesota - Clinical and Translational Science Institute:
thiazolidinedione
sulfonylurea
endothelial function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs