Diabetes MellitusPhase 3CHICAGONCT00225264
Efficacy Study of Pioglitazone and Glimepiride on the Rate of Progression of Atherosclerotic Disease.
A Phase 3 study testing Pioglitazone and Glimepiride in people with Diabetes Mellitus, run by Takeda at 1 site in United States.
Trial summary
The primary purpose of this study is to compare the effects of pioglitazone, once daily (QD), versus glimepiride on the amount of thickening of the carotid artery. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Pioglitazone and Glimepiride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to May 2006
- Phase
- Phase 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the time of randomization.
- Diagnosis of type 2 diabetes mellitus.
- Has received appropriate counseling on lifestyle modification for type 2 diabetes, including diet and exercise.
- Naïve to or not currently taking antidiabetic therapy, or is currently treated with monotherapy or combination antidiabetic therapy.
- Glycosylated hemoglobin greater than or equal to 6.0% and less than 9% at screening if taking antidiabetic medication or glycosylated hemoglobin greater than or equal to 6.5% and less than 10% at screening if naïve to or not taking antidiabetic medication.
Who cannot join
- Type 1 diabetes mellitus.
- Taking more than 2 antidiabetic therapies at screening. For combination medications, each component is counted as 1 therapy.
- Symptomatic coronary artery disease, cerebrovascular disease, or peripheral vascular disease at the time of screening.
- Taking or have taken pioglitazone or other thiazolidinediones within 12 weeks of randomization or were discontinued from thiazolidinedione therapy due to lack of efficacy or clinical or laboratory signs of intolerance.
- Was discontinued from glimepiride or other sulfonylureas due to lack of efficacy or clinical or laboratory signs of intolerance.
- Participating in another investigational study or has participated in an investigational study within the past 30 days or is scheduled to participate in an investigational study during the time frame of this study.
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- Women who are pregnant, intend to become pregnant during the course of the study, or are lactating.
- Men who have serum creatinine greater than or equal to 2.0 mg/dL (greater than or equal to 1.5 mg/dL if taking metformin) and women with serum creatinine greater than or equal to 1.8 mg/dL (greater than or equal to1.4 mg/dL if taking metformin).
- Unexplained microscopic hematuria of greater than plus 1 confirmed by repeat testing.
- History of drug abuse or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
- Clinical cardiac failure as defined by New York Heart Association class III or IV, or known left ventricular dysfunction measured as left ventricular ejection fraction less than 40%, or by current use of diuretics or angiotensin converting enzyme inhibitors for the treatment of heart failure. Use of these agents for other therapeutic reasons is not an exclusion.
- Alanine transaminase level of greater than 2.5 times the upper limit of normal, active liver disease or jaundice.
- Weighs greater than 300 pounds or has a body mass index greater than 45 kg/m2 as calculated by weight (kg)/height (m)2 or weight (pounds)/height (inches)2 x 703.
- Has taken excluded medications.
- Known or suspected malignancy or recurrence of malignancy within the past 5 years, with the exception of basal cell carcinoma and Stage 1 squamous cell carcinoma of the skin.
- Any disease where, in the opinion of the investigator, survival is expected to be less than 18 months.
- Anticipated to undergo coronary bypass surgery or cardiac intervention during the course of the study.
- Has, in the opinion of the investigator, clinically significant valvular heart disease likely to require surgical repair or replacement during the course of the study.
- Has had uncontrolled hypertension (ie, sitting systolic blood pressure greater than160 mm Hg or sitting diastolic blood pressure greater than 100 mm Hg) at randomization.
- Men who have hemoglobin less than10.5 g/dL and women who have hemoglobin less than10.0 g/dL.
- Triglycerides greater than 500 mg/dL.
- Unwilling or unable to comply with the protocol or scheduled appointments.
- Unable to understand verbal and/or written English or any other language for which a certified translation of the informed consent is available.
- Known or suspected hypersensitivity to blood, blood products, or albumin.
- Subjects for whom it is not possible to obtain good quality images of the common carotid artery for technical reasons.
- Potentially clinically significant stenosis of the carotid artery as determined according to current guidelines by the physician assessing carotid intima-media thickness results. In these cases, the carotid intima-media thickness results should be reviewed by the investigator in consultation with the carotid intima-media thickness physician prior to determining whether the subject should be randomized.
- Has had bilateral endarterectomies, bilateral carotid stents, or radiation to the head or neck.
- Has received radiation therapy in the past year, who has had more than one computed tomography scan in the past year, or who is unable to raise one's arms above one's head while in a prone position.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Comparator-Controlled Study in Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl Versus Glimepiride on the Rate of Progression of Atherosclerotic Disease as Measured by Carotid Intima-Media Thickness
The primary purpose of this study is to compare the effects of pioglitazone, once daily (QD), versus glimepiride on the amount of thickening of the carotid artery.
Read the detailed description
Diabetes is a chronic disease with multiple metabolic defects that result in hyperglycemia arising from inadequate insulin activity. Type 2 diabetes usually is the result of a progression from reduced sensitivity of hepatic and peripheral tissue cells to circulating insulin to a progressive inability of the body to produce adequate insulin to overcome insulin resistance, resulting in impaired glucose tolerance and ultimately overt diabetes. In the United States, an estimated 21 million people have diabetes, with type 2 diabetes occurring in approximately 90% to 95% of cases.
Type 2 diabetes also represents an important risk group for the development of accelerated atherosclerosis. Atherosclerosis can be measured with different procedures. One of the noninvasive, commonly used procedures is carotid B-mode ultrasound measurement of carotid intima-media thickness, which has been shown to be a useful measurement for clinical cardiovascular events in multiple studies.
Coronary artery calcification is a marker of coronary artery disease, and electron beam tomography is a sensitive tool for evaluation of coronary artery calcium. Electron beam tomography measurements produce a coronary artery calcium score that represents plaque burden. Subjects with diabetes mellitus have accelerated coronary artery disease. Even after treatment of elevated lipid levels, rates for coronary events still exceed those seen in non-diabetic subjects treated with the same lipid-lowering agents. Diabetic subjects also continue to have increased mortality rates compared with non-diabetic subjects after a myocardial infarction. Therefore, detection of sub-clinical atherosclerosis and prevention of myocardial infarction in subjects with diabetes remains an important priority.
Pioglitazone is a thiazolidinedione developed by Takeda Chemical Industries, Ltd, and depends on the presence of insulin for its mechanism of action. Data suggests that thiazolidinediones may inhibit the development of atherosclerosis in non-diabetic, atherosclerosis mouse models. These findings suggest that this class of drugs may have an effect on vessel walls to suppress development of atherosclerotic lesions.
This study will investigate the effects of pioglitazone and glimepiride on the rate of progression of atherosclerotic disease as measured by carotid intima-media thickness and by electron beam tomography of the coronary arteries in subjects with type 2 diabetes.
- Conditions
- Diabetes Mellitus
- Being tested
- Pioglitazone, Glimepiride
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
- Medical subject headings
- Diabetes Mellitus, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Diabetes Mellitus, Lipoatrophic, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos, AD-4833
Pioglitazone 15 mg titrated up to 45 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily for up to 72 weeks.
GlimepirideDrug
Also called Amaryl
Pioglitazone placebo-matching tablets, orally, once daily and glimepiride 1 mg titrated up to 4 mg, capsules, orally, once daily for up to 72 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone QD | Experimental | Not described Receives: Drug: Pioglitazone |
| Glimepiride QD | Active comparator | Not described Receives: Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from Baseline in carotid intima-media thickness.
Measured: Weeks 24, 48 and Final Visit.
Secondary outcomes (5)
Change from Baseline in carotid intima-media thickness.
Measured: Weeks 24, 48 and Final Visit.
Change from Baseline in coronary artery calcium-volume score.
Measured: At Final Visit
Change from Baseline in abdominal adipose tissue content and distribution.
Measured: At Final Visit
Incidence of cardiovascular events as a composite of cardiovascular mortality, nonfatal myocardial infarction and nonfatal stroke
Measured: At each occurrence
Incidence of cardiovascular events as a composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, coronary revascularization, carotid endarterectomy/stenting, hospitalization for unstable angina and hospitalization for CHF
Measured: At each occurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- VP Clinical Science Strategy, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225264
- Sponsor's protocol ID
- 01-02-TL-OPI-518
- Other IDs
- U1111-1114-2799
- Acronym
- CHICAGO
- Status last verified
- Feb 2012
- First submitted
- 21 Sep 2005
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mazzone T, Meyer PM, Feinstein SB, Davidson MH, Kondos GT, D'Agostino RB Sr, Perez A, Provost JC, Haffner SM. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes: a randomized trial. JAMA. 2006 Dec 6;296(21):2572-81. doi: 10.1001/jama.296.21.joc60158. Epub 2006 Nov 13.
PubMed 17101640Davidson M, Meyer PM, Haffner S, Feinstein S, D'Agostino R Sr, Kondos GT, Perez A, Chen Z, Mazzone T. Increased high-density lipoprotein cholesterol predicts the pioglitazone-mediated reduction of carotid intima-media thickness progression in patients with type 2 diabetes mellitus. Circulation. 2008 Apr 22;117(16):2123-30. doi: 10.1161/CIRCULATIONAHA.107.746610. Epub 2008 Apr 14.
PubMed 18413496Sam S, Haffner S, Davidson MH, D'Agostino RB Sr, Feinstein S, Kondos G, Perez A, Mazzone T. Relationship of abdominal visceral and subcutaneous adipose tissue with lipoprotein particle number and size in type 2 diabetes. Diabetes. 2008 Aug;57(8):2022-7. doi: 10.2337/db08-0157. Epub 2008 May 9.
PubMed 18469202Mazzone T, Meyer PM, Kondos GT, Davidson MH, Feinstein SB, D'Agostino RB Sr, Perez A, Haffner SM. Relationship of traditional and nontraditional cardiovascular risk factors to coronary artery calcium in type 2 diabetes. Diabetes. 2007 Mar;56(3):849-55. doi: 10.2337/db06-0935.
PubMed 17327456Sam S, Haffner S, Davidson MH, D'Agostino RB Sr, Feinstein S, Kondos G, Perez A, Mazzone T. Relation of abdominal fat depots to systemic markers of inflammation in type 2 diabetes. Diabetes Care. 2009 May;32(5):932-7. doi: 10.2337/dc08-1856. Epub 2009 Feb 19.
PubMed 19228869Betteridge DJ. CHICAGO, PERISCOPE and PROactive: CV risk modification in diabetes with pioglitazone. Fundam Clin Pharmacol. 2009 Dec;23(6):675-9. doi: 10.1111/j.1472-8206.2009.00741.x. Epub 2009 Sep 10.
PubMed 19744248
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Comparator-Controlled Study in Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl Versus Glimepiride on the Rate of Progression of Atherosclerotic Disease as Measured by Carotid Intima-Media Thickness
- ClinicalTrials.gov ID
- NCT00225264
- Acronym / sponsor ID
- CHICAGO / 01-02-TL-OPI-518
- Conditions
- Diabetes Mellitus
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 23 Sep 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 primary purpose of this study is to compare the effects of pioglitazone, once daily (QD), versus glimepiride on the amount of thickening of the carotid artery.
Detailed description
Diabetes is a chronic disease with multiple metabolic defects that result in hyperglycemia arising from inadequate insulin activity. Type 2 diabetes usually is the result of a progression from reduced sensitivity of hepatic and peripheral tissue cells to circulating insulin to a progressive inability of the body to produce adequate insulin to overcome insulin resistance, resulting in impaired glucose tolerance and ultimately overt diabetes. In the United States, an estimated 21 million people have diabetes, with type 2 diabetes occurring in approximately 90% to 95% of cases.
Type 2 diabetes also represents an important risk group for the development of accelerated atherosclerosis. Atherosclerosis can be measured with different procedures. One of the noninvasive, commonly used procedures is carotid B-mode ultrasound measurement of carotid intima-media thickness, which has been shown to be a useful measurement for clinical cardiovascular events in multiple studies.
Coronary artery calcification is a marker of coronary artery disease, and electron beam tomography is a sensitive tool for evaluation of coronary artery calcium. Electron beam tomography measurements produce a coronary artery calcium score that represents plaque burden. Subjects with diabetes mellitus have accelerated coronary artery disease. Even after treatment of elevated lipid levels, rates for coronary events still exceed those seen in non-diabetic subjects treated with the same lipid-lowering agents. Diabetic subjects also continue to have increased mortality rates compared with non-diabetic subjects after a myocardial infarction. Therefore, detection of sub-clinical atherosclerosis and prevention of myocardial infarction in subjects with diabetes remains an important priority.
Pioglitazone is a thiazolidinedione developed by Takeda Chemical Industries, Ltd, and depends on the presence of insulin for its mechanism of action. Data suggests that thiazolidinediones may inhibit the development of atherosclerosis in non-diabetic, atherosclerosis mouse models. These findings suggest that this class of drugs may have an effect on vessel walls to suppress development of atherosclerotic lesions.
This study will investigate the effects of pioglitazone and glimepiride on the rate of progression of atherosclerotic disease as measured by carotid intima-media thickness and by electron beam tomography of the coronary arteries in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone QD | Experimental | Drug: Pioglitazone |
| Glimepiride QD | Active comparator | Drug: Glimepiride |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the time of randomization.
- Diagnosis of type 2 diabetes mellitus.
- Has received appropriate counseling on lifestyle modification for type 2 diabetes, including diet and exercise.
- Naïve to or not currently taking antidiabetic therapy, or is currently treated with monotherapy or combination antidiabetic therapy.
- Glycosylated hemoglobin greater than or equal to 6.0% and less than 9% at screening if taking antidiabetic medication or glycosylated hemoglobin greater than or equal to 6.5% and less than 10% at screening if naïve to or not taking antidiabetic medication.
Key exclusion criteria (28 listed)
- Type 1 diabetes mellitus.
- Taking more than 2 antidiabetic therapies at screening. For combination medications, each component is counted as 1 therapy.
- Symptomatic coronary artery disease, cerebrovascular disease, or peripheral vascular disease at the time of screening.
- Taking or have taken pioglitazone or other thiazolidinediones within 12 weeks of randomization or were discontinued from thiazolidinedione therapy due to lack of efficacy or clinical or laboratory signs of intolerance.
- Was discontinued from glimepiride or other sulfonylureas due to lack of efficacy or clinical or laboratory signs of intolerance.
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 |
|---|---|---|
| PioglitazoneAlso: Actos, AD-4833Pioglitazone 15 mg titrated up to 45 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily for up to 72 weeks. | Drug | Pioglitazone QD |
| GlimepirideAlso: AmarylPioglitazone placebo-matching tablets, orally, once daily and glimepiride 1 mg titrated up to 4 mg, capsules, orally, once daily for up to 72 weeks. | Drug | Glimepiride QD |
Primary outcome
Absolute change from Baseline in carotid intima-media thickness.
Time frame: Weeks 24, 48 and Final Visit.
5 secondary outcomes
Change from Baseline in carotid intima-media thickness.
Time frame: Weeks 24, 48 and Final Visit.
Change from Baseline in coronary artery calcium-volume score.
Time frame: At Final Visit
Change from Baseline in abdominal adipose tissue content and distribution.
Time frame: At Final Visit
Incidence of cardiovascular events as a composite of cardiovascular mortality, nonfatal myocardial infarction and nonfatal stroke
Time frame: At each occurrence
Incidence of cardiovascular events as a composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, coronary revascularization, carotid endarterectomy/stenting, hospitalization for unstable angina and hospitalization for CHF
Time frame: At each occurrence
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 28 Feb 2012.
- Results publication: PubMed 17101640Mazzone T, Meyer PM, Feinstein SB, Davidson MH, Kondos GT, D'Agostino RB Sr, Perez A, Provost JC, Haffner SM. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes: a randomized trial. JAMA. 2006 Dec 6;296(21):2572-81. doi: 10.1001/jama.296.21.joc60158. Epub 2006 Nov 13.
- Results publication: PubMed 18413496Davidson M, Meyer PM, Haffner S, Feinstein S, D'Agostino R Sr, Kondos GT, Perez A, Chen Z, Mazzone T. Increased high-density lipoprotein cholesterol predicts the pioglitazone-mediated reduction of carotid intima-media thickness progression in patients with type 2 diabetes mellitus. Circulation. 2008 Apr 22;117(16):2123-30. doi: 10.1161/CIRCULATIONAHA.107.746610. Epub 2008 Apr 14.
- Results publication: PubMed 18469202Sam S, Haffner S, Davidson MH, D'Agostino RB Sr, Feinstein S, Kondos G, Perez A, Mazzone T. Relationship of abdominal visceral and subcutaneous adipose tissue with lipoprotein particle number and size in type 2 diabetes. Diabetes. 2008 Aug;57(8):2022-7. doi: 10.2337/db08-0157. Epub 2008 May 9.
- Results publication: PubMed 17327456Mazzone T, Meyer PM, Kondos GT, Davidson MH, Feinstein SB, D'Agostino RB Sr, Perez A, Haffner SM. Relationship of traditional and nontraditional cardiovascular risk factors to coronary artery calcium in type 2 diabetes. Diabetes. 2007 Mar;56(3):849-55. doi: 10.2337/db06-0935.
- Results publication: PubMed 19228869Sam S, Haffner S, Davidson MH, D'Agostino RB Sr, Feinstein S, Kondos G, Perez A, Mazzone T. Relation of abdominal fat depots to systemic markers of inflammation in type 2 diabetes. Diabetes Care. 2009 May;32(5):932-7. doi: 10.2337/dc08-1856. Epub 2009 Feb 19.
- Results publication: PubMed 19744248Betteridge DJ. CHICAGO, PERISCOPE and PROactive: CV risk modification in diabetes with pioglitazone. Fundam Clin Pharmacol. 2009 Dec;23(6):675-9. doi: 10.1111/j.1472-8206.2009.00741.x. Epub 2009 Sep 10.
- ACTOS® Package InsertLink provided by the sponsor.
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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.
VP Clinical Science Strategy study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pioglitazone and Glimepiride in people with Diabetes Mellitus, run by Takeda 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 28 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 28 Feb 2012. 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 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?
Absolute change from Baseline in carotid intima-media thickness. (time frame: Weeks 24, 48 and Final Visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00225264, which also lists 6 linked publications.
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 28 Feb 2012.