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Diabetes Mellitus, Type 2Phase 3NCT00123227

Rosiglitazone Plaque Study

A Phase 3 study testing Rosiglitazone in people with Diabetes Mellitus, Type 2 and Vascular Diseases, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether rosiglitazone, a peroxisome proliferator activated receptor gamma (PPAR-gamma) agonist, induces regression in carotid atherosclerotic plaques in diabetic patients with vascular disease and/or hypertension over a 12 month period. Read more about this study

Who is it for?
Ages 30 to 75 years
What is being tested?
Rosiglitazone
How many people
60 participants
Where
2 sitesUnited Kingdom
Study dates
Oct 2002to May 2005
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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with type 2 diabetes as defined by the World Health Organization (WHO) criteria
  • Male or female patient who is 30 to 75 years of age at screening
  • Patients with coexisting vascular disease (previous myocardial infarction, cerebrovascular accident or peripheral vascular disease) or hypertension (BP > 150/90)
  • Patients who have initiated statin and fibrate therapy at least 6 months prior to screening, and have been receiving a stable dose for at least 3 months prior to screening. [Note: patients not receiving statin or fibrate therapy will be allowed to enter the study providing that this method of treatment is not required as active treatment for their medical condition at the time of screening; if any of these patients develop the need for statin or fibrate therapy during the course of the study, therapy will be started without the need to withdraw the patient from the study.]
  • Female patients must be post-menopausal, surgically sterile, or using effective contraceptive measures. Women of childbearing age must use effective contraceptive measures for at least 1 month prior to visit 1 (screening), and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study treatment.
  • Patients who give their signed informed consent to participate.
  • Patients with an HbA1c value < 10% at screening visit.
  • Patients with evidence of at least one atheromatous plaque causing narrowing of internal carotid artery between 10 and 95%. Diagnosis to be performed prior to randomisation by colour duplex examination.

Who cannot join

  • Patients who have taken >2 concomitant oral anti-hypertensive agents (i.e. oral combination) within the 3 months prior to the screening visit (visit 1)
  • Previous exposure to a thiazolidinedione (TZD) or other PPAR-gamma agonist (e.g. rosiglitazone, troglitazone, pioglitazone, GI262570) or participation in a double-blind clinical study involving a TZD or PPAR-gamma agonist where the randomisation code has not been broken prior to visit 1 (screening) of this study.
  • Patients who have required the chronic use of insulin for glycaemic control at any time in the past (with the exception of those who have needed short-term insulin use to maintain glycaemic control during a hospitalisation, during pregnancy or during a medical procedure or intervention) or patients with a history of ketoacidosis.
  • Use of any investigational drug within 30 days of 5 half-lives preceding the first dose of medication at the start of the study.
  • Systolic blood pressure >170 mmHg or diastolic blood pressure > 100mHg.
  • Patients with unstable or severe angina or congestive heart failure (New York Heart Association [NYHA] class I-IV)
Show all 18Show fewer
  • History of gangrene or transient ischaemic attack (TIA)
  • History of stroke within the previous year.
  • Presence of clinically significant hepatic disease (i.e. patients with ALT, total bilirubin, or alkaline phosphatase > 2.5 times the upper limit of the normal laboratory range)
  • Any pre-existing condition or clinically significant abnormality identified in the screening (visit 1) physical examination, electrocardiogram, ultrasound examination or laboratory tests which, in the judgement of the investigator, would preclude safe completion of the study.
  • Clinically significant anaemia defined by haemoglobin concentration <11g/dL for males, or <10 g/dL for females
  • Patients with creatinine > 150 umol/L.
  • Women who are lactating, pregnant, or planning to become pregnant during the course of the study.
  • Alcohol or drug abuse within the last 6 months.
  • Previous surgery to carotid arteries.
  • Pacemakers, cerebral aneurysm clips, claustrophobia or any implantable devices incompatible with magnetic resonance imaging.
  • Patients exhibiting total occlusion of the internal carotid artery (when assessed by colour duplex examination performed).
  • Patients unable to lie supine for 60 minutes.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Cardiovascular Magnetic Resonance Unit, Royal Brompton Hospital

    London, SW3 6NP

  • St Mary's NHS Trust

    London, W2 1NY

Other trials in United Kingdom

About this study

Official title: A Randomised, Double-Blind, Placebo-Controlled, Cardiovascular Magnetic Resonance (CMR) Study to Evaluate the Effect of Rosiglitazone on Carotid Atherosclerotic Plaques in Type 2 Diabetics With Vascular Disease or Hypertension

The purpose of this study is to determine whether rosiglitazone, a peroxisome proliferator activated receptor gamma (PPAR-gamma) agonist, induces regression in carotid atherosclerotic plaques in diabetic patients with vascular disease and/or hypertension over a 12 month period.

Read the detailed description

Rosiglitazone is a new member of the thiazolidinediones (TZDs), a class of drugs which act by binding to peroxisome proliferator activated receptor gamma (PPAR-gamma). It has been suggested that the TZD class od anti-diabetic drug may exhibit anti-atherosclerotic effects. The aim of this study is to evaluate over a 12 month period the potential benefits of rosiglitazone on carotid artery atherosclerotic plaques in the type 2 diabetic population with coexisting vascular disease or hypertension. It is hypothesised that treatment with rosiglitazone will lead to a decrease in plaque size. In addition it is hoped that rosiglitazone will have a positive effect on the plaque composition and stability.

The primary endpoint will be the plaque volume change over 12 months as assessed by cardiovascular magnetic resonance (CMR). The effectiveness of this modality to evaluate the effects of pharmacological agents on atherosclerosis in vivo has been demonstrated in previous studies using statins.

The secondary endpoints will be to define the changes in plaque lipid content, fibrous cap thickness and gadolinium enhancement as a measure of fibrous cap inflammation and plaque neovascularisation.

Being tested
Rosiglitazone
Keywords
Randomised controlled trial, Rosiglitazone, Cardiovascular magnetic resonance, Diabetes Mellitus, Vascular Diseases, Hypertension
Medical subject headings
Diabetes Mellitus, Type 2, Vascular Diseases, Hypertension, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RosiglitazoneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plaque volume change over 12 months as assessed by cardiovascular magnetic resonance (CMR)

Secondary outcomes (3)

  1. Change in plaque lipid content

  2. Change in plaque fibrous cap thickness

  3. Change in plaque gadolinium enhancement as a measure of fibrous cap inflammation and plaque neovascularisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2005 (estimated)
  2. Study startOct 2002
  3. Study completionMay 2005

Resources

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
Single group
Masking
Double blind
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00123227
Sponsor's protocol ID
02-210
Status last verified
May 2005
First submitted
19 Jul 2005
Last updated
1 Aug 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosiglitazone in people with Diabetes Mellitus, Type 2 and Vascular Diseases, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.

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 8 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 1 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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?

Results are not available in the source record.

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?

Plaque volume change over 12 months as assessed by cardiovascular magnetic resonance (CMR). 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 NCT00123227.

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 1 Aug 2005.

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