AtherosclerosisPhase 2/3NCT00116545
TART - Troglitazone Atherosclerosis Regression Trial
A Phase 2/3 study testing troglitazone in people with Atherosclerosis and Diabetes Mellitus, run by Parke-Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine if troglitazone reduces the progression of early preintrusive carotid atherosclerosis in insulin-requiring diabetes patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Atherosclerosis, Diabetes Mellitus
- What is being tested?
- troglitazone
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1997to Apr 2000
- Phase
- Phase 2/3
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ages 30-70 years
- Diabetes: fasting glucose over 140 mg/dL but under 350 mg/dL on at least 2 occasions
- At least 30 years of age at onset of diabetes
- Metabolic control and management requiring insulin without other anti-diabetic medications
- Willingness to sign informed consent
Who cannot join
- Known sensitivity to troglitazone or other thiazolidinediones
- For premenopausal females: pregnancy, breastfeeding, unwilling to use effective contraception for the duration of the trial
- Active liver disease or hepatic dysfunction; renal dysfunction; high blood pressure; major vascular events within 6 months prior to randomization; untreated hypothyroidism or uncured hyperthyroidism; other severe or unstable disease within 5 years of randomization
- Medical illness that may require oral or parenteral glucocorticoid therapy
- Physical disability that would interfere with diabetes self-management
- Untreated or unstable diabetic retinopathy
Show all 10Show fewer
- History of insulin allergy
- Present or recent history of alcohol intake over 5 drinks per day or substance abuse
- Participation in another clinical trial
- Currently taking nicotinic acid
Trial locations and contacts
1 site in 1 country.
United States1 site
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, 90033
About this study
The purpose of this study is to determine if troglitazone reduces the progression of early preintrusive carotid atherosclerosis in insulin-requiring diabetes patients.
Read the detailed description
Insulin resistance and hyperinsulinism appear to be important risk factors for the development of atherosclerosis in diabetes patients. The atherogenic potential of insulin has been shown to improve cholesterol and may have an effect on the thickness and structure of the arterial wall. Troglitazone is an oral diabetic agent that treats insulin resistance. Based on the initial data available, it would appear that troglitazone may be effective in both glycemic control and improved atherosclerosis risk in diabetes patients. This study will compare the effects of troglitazone to placebo in insulin-requiring diabetes patients on both glycemic control and progression of atherosclerosis.
A total of 288 men and women 30 to 70 years of age with insulin-treated diabetes were recruited and entered an 8 week run-in phase to stabilize diet, exercise, insulin dose and glucose levels. Upon successful completion of the run-in phase, all patients were randomized into one of two groups to receive either troglitazone 400mg/day or a matching placebo while continuing with diet and exercise regimens and insulin dose to maintain pre-meal glucose levels between 100 to 150 mg/dL.
Follow up visits occurred every 2 weeks for 2 months, every 4 weeks for 2 months, then every 8 weeks for the remainder of the 2-year trial. The progression of atherosclerosis was measured by ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment.
- Conditions
- Atherosclerosis, Diabetes Mellitus
- Being tested
- troglitazone
- Keywords
- IDDM, Insulin, cardiovascular disease
- Medical subject headings
- Atherosclerosis, Diabetes Mellitus, Diabetes Mellitus, Type 1, Insulin Resistance, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
troglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of change of the right distal common carotid artery far wall intima-media thickness (IMT) measured every 6 months
flow mediated brachial artery vasoactivity
Secondary outcomes (1)
carbohydrate and lipid metabolism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2005 (estimated)
- Study startJan 1997
- Primary completionApr 2000
- Study completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 288 participants
Sponsor and investigators
- Lead sponsor
- Parke-Davis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Howard N. Hodis, MD, Principal investigator, University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116545
- Sponsor's protocol ID
- AG0028
- Other IDs
- 991-081-00
- Status last verified
- Jun 2005
- First submitted
- 29 Jun 2005
- Last updated
- 11 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TART - Troglitazone Atherosclerosis Regression Trial
- ClinicalTrials.gov ID
- NCT00116545
- Acronym / sponsor ID
- AG0028
- Conditions
- Atherosclerosis, Diabetes Mellitus
- Keywords
- IDDM, Insulin, cardiovascular disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants
- Lead sponsor
- Parke-DavisIndustry (pharma, biotech, devices)
- Study start
- Jan 1997
- Primary completion
- Apr 2000 (actual)
- Study completion
- Apr 2000 (actual)
- First posted
- 30 Jun 2005 (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 determine if troglitazone reduces the progression of early preintrusive carotid atherosclerosis in insulin-requiring diabetes patients.
Detailed description
Insulin resistance and hyperinsulinism appear to be important risk factors for the development of atherosclerosis in diabetes patients. The atherogenic potential of insulin has been shown to improve cholesterol and may have an effect on the thickness and structure of the arterial wall. Troglitazone is an oral diabetic agent that treats insulin resistance. Based on the initial data available, it would appear that troglitazone may be effective in both glycemic control and improved atherosclerosis risk in diabetes patients. This study will compare the effects of troglitazone to placebo in insulin-requiring diabetes patients on both glycemic control and progression of atherosclerosis.
A total of 288 men and women 30 to 70 years of age with insulin-treated diabetes were recruited and entered an 8 week run-in phase to stabilize diet, exercise, insulin dose and glucose levels. Upon successful completion of the run-in phase, all patients were randomized into one of two groups to receive either troglitazone 400mg/day or a matching placebo while continuing with diet and exercise regimens and insulin dose to maintain pre-meal glucose levels between 100 to 150 mg/dL.
Follow up visits occurred every 2 weeks for 2 months, every 4 weeks for 2 months, then every 8 weeks for the remainder of the 2-year trial. The progression of atherosclerosis was measured by ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women ages 30-70 years
- Diabetes: fasting glucose over 140 mg/dL but under 350 mg/dL on at least 2 occasions
- At least 30 years of age at onset of diabetes
- Metabolic control and management requiring insulin without other anti-diabetic medications
- Willingness to sign informed consent
Key exclusion criteria (10 listed)
- Known sensitivity to troglitazone or other thiazolidinediones
- For premenopausal females: pregnancy, breastfeeding, unwilling to use effective contraception for the duration of the trial
- Active liver disease or hepatic dysfunction; renal dysfunction; high blood pressure; major vascular events within 6 months prior to randomization; untreated hypothyroidism or uncured hyperthyroidism; other severe or unstable disease within 5 years of randomization
- Medical illness that may require oral or parenteral glucocorticoid therapy
- Physical disability that would interfere with diabetes self-management
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 |
|---|---|---|
| troglitazone | Drug | – |
Primary outcome
rate of change of the right distal common carotid artery far wall intima-media thickness (IMT) measured every 6 months
flow mediated brachial artery vasoactivity
1 secondary outcome
carbohydrate and lipid metabolism
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 11 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.
Howard N. Hodis, MD principal investigator
University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing troglitazone in people with Atherosclerosis and Diabetes Mellitus, run by Parke-Davis 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 10 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 11 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
rate of change of the right distal common carotid artery far wall intima-media thickness (IMT) measured every 6 months. The study lists 2 primary outcomes in all. 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 11 Dec 2009.