- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00123643
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
Conditions
Intervention / Treatment
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GSK2002-2
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.
Clinical Trials on Type 2 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
AstraZenecaNot yet recruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on rosiglitazone
-
Solvay PharmaceuticalsCompletedType 2 Diabetes MellitusUnited Kingdom
-
Centre Hospitalier Universitaire DijonCompleted
-
GlaxoSmithKlineCompletedDiabetes Mellitus, Type 2
-
GlaxoSmithKlineCompletedDiabetes Mellitus, Type 2
-
GlaxoSmithKlineCompletedNeuropathy, DiabeticNetherlands
-
Medstar Health Research InstituteGlaxoSmithKlineTerminated
-
Baskent UniversityCompletedObesity | Type 2 Diabetes MellitusTurkey
-
Hospital Authority, Hong KongUnknownCardiovascular Diseases | Kidney Diseases | Chronic DiseaseChina
-
GlaxoSmithKlineCompletedAlzheimer's DiseaseUnited States, Australia, Spain, Bulgaria, Poland, Germany, Philippines, Singapore, Belgium, Canada, Hong Kong, Korea, Republic of, Finland, Slovenia, Czechia, France, South Africa, Sweden, Netherlands, Malaysia, United Kingdom, S...
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)Completed