Diabetes Mellitus, Type 2Phase 4NCT00571506
Effect of Thiazolidinedione Treatment Vascular Risk Markers
A Phase 4 study testing Rosiglitazone and Pioglitazone in people with Diabetes Mellitus, Type 2 and Vascular Diseases, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of two diabetes medications, rosiglitazone and pioglitazone, on markers of vascular disease in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Vascular Diseases
- What is being tested?
- Rosiglitazone and Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Aug 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women of all races
- Age 40-65 years
- Diagnosis of type 2 diabetes
- hemoglobin A1C ≥ 7%
- eligible whether or not currently taking antihyperglycemic medications
Who cannot join
- History of rosiglitazone or pioglitazone use in the previous 3 months
- Known diagnosis of peripheral vascular disease or cardiac failure
- Recent history (within past 6 months) of ischemic stroke, myocardial infarction, percutaneous coronary intervention, or coronary artery bypass surgery
- Active liver disease or elevated serum transaminases (ALT >2.5x upper limit of normal)
- Current therapy with oral anticoagulants (warfarin, heparin, low molecular weight heparin), clopidogrel, or immunosuppressive agents
- Pregnancy or breastfeeding
- Any other condition, in the opinion of the investigator, that renders the subject unable to complete the study, that interferes with optimal participation in the study, or that produces significant risk to the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: A Pilot Study to Determine the Effects of Short-term Thiazolidinedione Treatment on Vascular Risk Markers in Type 2 Diabetes Patients
The purpose of this study is to examine the effects of two diabetes medications, rosiglitazone and pioglitazone, on markers of vascular disease in subjects with type 2 diabetes.
Read the detailed description
Diabetes is a common disease in the United States, affecting over 10 million Americans. Vascular disease, including heart attack and stroke, affects many diabetic patients and will cause the death of three-fourths of these patients. Because the majority of diabetic patients will suffer complications or death from vascular disease, we will explore treatments that have the potential to reduce or prevent vascular disease in type 2 diabetes patients. Our study will examine the effects of two diabetes medications, rosiglitazone (ROSI) and pioglitazone (PIO), on markers of vascular disease in 20 subjects with type 2 diabetes. It is thought that these two medications will reduce the risk of vascular disease by affecting the platelets and proteins that that regulate the processes involved in clot formation. One-half of the subjects enrolled in our study will take ROSI and the other half will take PIO. We will measure the clumping ability of these subjects' platelets before, during, and after three months of treatment with ROSI or PIO. We will measure the blood concentrations of several proteins (fibrinogen, PAI-1, CRP, adiponectin, and leptin) before and after treatment with the study drugs. These experiments will give us information about any beneficial effects of ROSI and PIO on the clot-forming ability in diabetes patients. We expect that treatment with ROSI and PIO will result in improvement of the disturbed clot-forming processes that predispose diabetic patients to vascular disease.
- Conditions
- Diabetes Mellitus, Type 2, Vascular Diseases
- Being tested
- Rosiglitazone, Pioglitazone
- Keywords
- Diabetes Mellitus, Type 2, Vascular Diseases, Thiazolidinediones, Platelet Aggregation
- Medical subject headings
- Diabetes Mellitus, Type 2, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
Also called Avandia
Rosiglitazone 4 mg tablets by mouth daily for 3 months
PioglitazoneDrug
Also called Actos
Pioglitazone 30 mg tablet by mouth once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rosiglitazone 4 mg by mouth daily Receives: Drug: Rosiglitazone |
| 2 | Active comparator | Pioglitazone 30 mg by mouth daily Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine if treatment with rosiglitazone or pioglitazone affects platelet function as assessed by spontaneous and agonist-induced platelet aggregation
Measured: 3 months
Secondary outcomes (1)
adipocytokine concentrations (adiponectin, leptin), hemostatic parameters (fibrinogen, plasminogen activator inhibitor-1), high-sensitivity C-reactive protein
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startMay 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Investigators
- Amy M. Franks, Pharm.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571506
- Sponsor's protocol ID
- 26963
- Status last verified
- Dec 2009
- First submitted
- 10 Dec 2007
- Last updated
- 9 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Effects of Short-term Thiazolidinedione Treatment on Vascular Risk Markers in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT00571506
- Acronym / sponsor ID
- 26963
- Conditions
- Diabetes Mellitus, Type 2, Vascular Diseases
- Keywords
- Diabetes Mellitus, Type 2, Vascular Diseases, Thiazolidinediones, Platelet Aggregation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
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 examine the effects of two diabetes medications, rosiglitazone and pioglitazone, on markers of vascular disease in subjects with type 2 diabetes.
Detailed description
Diabetes is a common disease in the United States, affecting over 10 million Americans. Vascular disease, including heart attack and stroke, affects many diabetic patients and will cause the death of three-fourths of these patients. Because the majority of diabetic patients will suffer complications or death from vascular disease, we will explore treatments that have the potential to reduce or prevent vascular disease in type 2 diabetes patients. Our study will examine the effects of two diabetes medications, rosiglitazone (ROSI) and pioglitazone (PIO), on markers of vascular disease in 20 subjects with type 2 diabetes. It is thought that these two medications will reduce the risk of vascular disease by affecting the platelets and proteins that that regulate the processes involved in clot formation. One-half of the subjects enrolled in our study will take ROSI and the other half will take PIO. We will measure the clumping ability of these subjects' platelets before, during, and after three months of treatment with ROSI or PIO. We will measure the blood concentrations of several proteins (fibrinogen, PAI-1, CRP, adiponectin, and leptin) before and after treatment with the study drugs. These experiments will give us information about any beneficial effects of ROSI and PIO on the clot-forming ability in diabetes patients. We expect that treatment with ROSI and PIO will result in improvement of the disturbed clot-forming processes that predispose diabetic patients to vascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RosiglitazoneRosiglitazone 4 mg by mouth daily |
| 2 | Active comparator | Drug: PioglitazonePioglitazone 30 mg by mouth daily |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women of all races
- Age 40-65 years
- Diagnosis of type 2 diabetes
- hemoglobin A1C ≥ 7%
- eligible whether or not currently taking antihyperglycemic medications
Key exclusion criteria (7 listed)
- History of rosiglitazone or pioglitazone use in the previous 3 months
- Known diagnosis of peripheral vascular disease or cardiac failure
- Recent history (within past 6 months) of ischemic stroke, myocardial infarction, percutaneous coronary intervention, or coronary artery bypass surgery
- Active liver disease or elevated serum transaminases (ALT >2.5x upper limit of normal)
- Current therapy with oral anticoagulants (warfarin, heparin, low molecular weight heparin), clopidogrel, or immunosuppressive agents
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 |
|---|---|---|
| RosiglitazoneAlso: AvandiaRosiglitazone 4 mg tablets by mouth daily for 3 months | Drug | 1 |
| PioglitazoneAlso: ActosPioglitazone 30 mg tablet by mouth once daily | Drug | 2 |
Primary outcome
determine if treatment with rosiglitazone or pioglitazone affects platelet function as assessed by spontaneous and agonist-induced platelet aggregation
Time frame: 3 months
1 secondary outcome
adipocytokine concentrations (adiponectin, leptin), hemostatic parameters (fibrinogen, plasminogen activator inhibitor-1), high-sensitivity C-reactive protein
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2009.
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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.
Amy M. Franks, Pharm.D. principal investigator
University of Arkansas
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 Pioglitazone in people with Diabetes Mellitus, Type 2 and Vascular Diseases, run by University of Arkansas 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 5 inclusion and 7 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 9 Dec 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
determine if treatment with rosiglitazone or pioglitazone affects platelet function as assessed by spontaneous and agonist-induced platelet aggregation (time frame: 3 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 9 Dec 2009.