Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Aaron S. Kelly, Ph.D., University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00123643
First received: July 21, 2005
Last updated: June 26, 2013
Last verified: June 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Flow Mediated Dilation [ Time Frame: change from baseline to 6 months ] [ Designated as safety issue: No ]
    Measure of endothelial function


Enrollment: 36
Study Start Date: May 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosiglitazone Drug: rosiglitazone
Active Comparator: Glyburide Drug: glyburide

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Study First Received: July 21, 2005
Results First Received: July 2, 2012
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Paul Heart Clinic:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014