Type 2 Diabetes MellitusPhase 4NCT00123643
Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
A Phase 4 study testing rosiglitazone and glyburide in people with Type 2 Diabetes Mellitus, run by St. Paul Heart Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- rosiglitazone and glyburide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Dec 2005
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- rosiglitazone, glyburide
- Keywords
- thiazolidinedione, sulfonylurea, endothelial function
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazoneDrug
glyburideDrug
| Study group | Role | What they receive |
|---|---|---|
| Rosiglitazone | Experimental | Not described Receives: Drug: rosiglitazone |
| Glyburide | Active comparator | Not described Receives: Drug: glyburide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilation
Measure of endothelial function
Measured: change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2005 (estimated)
- Study startMay 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Paul Heart Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Aaron S. Kelly, Ph.D., University of Minnesota
- Investigators
- Alan J Bank, M.D., Principal investigator, St. Paul Heart Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123643
- Sponsor's protocol ID
- GSK2002-2
- Status last verified
- Jun 2013
- First submitted
- 21 Jul 2005
- Last updated
- 15 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00123643
- Acronym / sponsor ID
- GSK2002-2
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- thiazolidinedione, sulfonylurea, endothelial function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- St. Paul Heart ClinicUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 25 Jul 2005 (estimated)
- Results
- Posted 9 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosiglitazone | Experimental | Drug: rosiglitazone |
| Glyburide | Active comparator | Drug: glyburide |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosiglitazone | Drug | Rosiglitazone |
| glyburide | Drug | Glyburide |
Primary outcome
Flow Mediated Dilation
Time frame: change from baseline to 6 months
Measure of endothelial function
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan J Bank, M.D. principal investigator
St. Paul Heart Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rosiglitazone and glyburide in people with Type 2 Diabetes Mellitus, run by St. Paul Heart Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow Mediated Dilation (time frame: change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.