Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

June 26, 2013 updated by: Aaron S. Kelly, Ph.D., St. Paul Heart Clinic

Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function 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.

Study Overview

Status

Completed

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

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glyburide
Experimental: Rosiglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow Mediated Dilation
Time Frame: change from baseline to 6 months
Measure of endothelial function
change from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

July 21, 2005

First Submitted That Met QC Criteria

July 21, 2005

First Posted (Estimate)

July 25, 2005

Study Record Updates

Last Update Posted (Estimate)

July 15, 2013

Last Update Submitted That Met QC Criteria

June 26, 2013

Last Verified

June 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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