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OpenTrials
Completed

NCT Number: NCT00123643

Vascular Effects of Rosiglitazone Versus Glyburide 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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Paul Heart Clinic

Saint Paul, Minnesota, 55102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone

Drug

Glyburide

Drug

Primary outcomes

  1. Flow Mediated Dilation

    Time frame: change from baseline to 6 months

    Measure of endothelial function

Sponsors and collaborators

Lead sponsor

St. Paul Heart Clinic

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jul 25, 2005
Registry last updated
Jul 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.