Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 type-2-diabetes-mellitus
Started May 2003
Typical duration for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 21, 2005
CompletedFirst Posted
Study publicly available on registry
July 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedResults Posted
Study results publicly available
August 9, 2012
CompletedJuly 15, 2013
June 1, 2013
2.6 years
July 21, 2005
July 2, 2012
June 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Flow Mediated Dilation
Measure of endothelial function
change from baseline to 6 months
Study Arms (2)
Rosiglitazone
EXPERIMENTALGlyburide
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Paul Heart Cliniclead
- GlaxoSmithKlinecollaborator
Study Sites (1)
St. Paul Heart Clinic
Saint Paul, Minnesota, 55102, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size; unbalanced sex distribution between groups
Results Point of Contact
- Title
- Aaron S. Kelly, Ph.D.
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Alan J Bank, M.D.
St. Paul Heart Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 21, 2005
First Posted
July 25, 2005
Study Start
May 1, 2003
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
July 15, 2013
Results First Posted
August 9, 2012
Record last verified: 2013-06