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Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 21, 2005
First Posted Date  ICMJE July 25, 2005
Results First Submitted Date  ICMJE July 2, 2012
Results First Posted Date  ICMJE August 9, 2012
Last Update Posted Date July 15, 2013
Study Start Date  ICMJE May 2003
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
Flow Mediated Dilation [ Time Frame: change from baseline to 6 months ]
Measure of endothelial function
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
Improvement in endothelial function
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
Improvement in markers of inflammation and oxidative stress
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
Official Title  ICMJE Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: rosiglitazone
  • Drug: glyburide
Study Arms  ICMJE
  • Experimental: Rosiglitazone
    Intervention: Drug: rosiglitazone
  • Active Comparator: Glyburide
    Intervention: Drug: glyburide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2012)
36
Original Enrollment  ICMJE
 (submitted: July 21, 2005)
40
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00123643
Other Study ID Numbers  ICMJE GSK2002-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aaron S. Kelly, Ph.D., University of Minnesota
Study Sponsor  ICMJE St. Paul Heart Clinic
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Alan J Bank, M.D. St. Paul Heart Clinic
PRS Account St. Paul Heart Clinic
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP