Diabetes Mellitus, Type 2Phase 4NCT00306644
Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes
A Phase 4 study testing Rosiglitazone in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in Sweden.
Trial summary
The study investigated the effect of rosiglitazone and placebo on carotid intima media thickness in patients with insulin resistance syndrome and/or type 2 diabetes. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Rosiglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteSweden
- Study dates
- May 2002to Nov 2004
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- insulin resistant syndrome or Type 2 Diabetes.
Who cannot join
- Use of >= 2 concomitant oral antihyperglycaemic agents within 3 months of study start.
- Initiation of anti-hypertensive or lipid lowering therapy <= 6 months prior to study start or who increased the dose 3 months prior to study start.
- Unstable or severe angina or congestive heart failure NYHA class i-iv, history of acute myocardial infarction or stroke within last 6 months.
- Any history of surgical intervention in the right carotid artery.
- Clinically significant hepatic disease.
- Creatinine clearance <40ml/min.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rosiglitazone and Placebo on Carotid Intima Media Thickness in Patients With Insulin Resistance Syndrome and/or Type 2 Diabetes
The study investigated the effect of rosiglitazone and placebo on carotid intima media thickness in patients with insulin resistance syndrome and/or type 2 diabetes.
Read the detailed description
RAS Rosiglitazone and Atherosclerosis Study: A 1 year randomised, double-blind, parallel group, placebo controlled study to evaluate the efficacy of rosiglitazone on the progression of intima-media thickness in the carotid artery in subjects with insulin resistance syndrome and/or type 2 diabetes mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Rosiglitazone
- Keywords
- rosiglitazone, Type 2 diabetes, intima media thickness, Insulin resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
study drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | study drug Receives: Drug: Rosiglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment.
Measured: 52 weeks
Secondary outcomes (1)
Plaque occurrence & stenosis within the right carotid artery.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startMay 2002
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306644
- Sponsor's protocol ID
- 49653/334
- Status last verified
- Aug 2016
- First submitted
- 22 Mar 2006
- Last updated
- 1 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Hedblad B, Zambanini A, Nilsson P, Janzon L, Berglund G. Rosiglitazone and carotid IMT progression rate in a mixed cohort of patients with type 2 diabetes and the insulin resistance syndrome: main results from the Rosiglitazone Atherosclerosis Study. J Intern Med. 2007 Mar;261(3):293-305. doi: 10.1111/j.1365-2796.2007.01767.x.
PubMed 17305652
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rosiglitazone and Placebo on Carotid Intima Media Thickness in Patients With Insulin Resistance Syndrome and/or Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00306644
- Acronym / sponsor ID
- 49653/334
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- rosiglitazone, Type 2 diabetes, intima media thickness, Insulin resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 24 Mar 2006 (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 study investigated the effect of rosiglitazone and placebo on carotid intima media thickness in patients with insulin resistance syndrome and/or type 2 diabetes.
Detailed description
RAS Rosiglitazone and Atherosclerosis Study: A 1 year randomised, double-blind, parallel group, placebo controlled study to evaluate the efficacy of rosiglitazone on the progression of intima-media thickness in the carotid artery in subjects with insulin resistance syndrome and/or type 2 diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Rosiglitazonestudy drug |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- insulin resistant syndrome or Type 2 Diabetes.
Key exclusion criteria (6 listed)
- Use of >= 2 concomitant oral antihyperglycaemic agents within 3 months of study start.
- Initiation of anti-hypertensive or lipid lowering therapy <= 6 months prior to study start or who increased the dose 3 months prior to study start.
- Unstable or severe angina or congestive heart failure NYHA class i-iv, history of acute myocardial infarction or stroke within last 6 months.
- Any history of surgical intervention in the right carotid artery.
- Clinically significant hepatic disease.
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 |
|---|---|---|
| Rosiglitazonestudy drug | Drug | Arm 1 |
Primary outcome
Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment.
Time frame: 52 weeks
1 secondary outcome
Plaque occurrence & stenosis within the right carotid artery.
Time frame: 52 weeks
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 1 Sep 2016.
- Results publication: PubMed 17305652Hedblad B, Zambanini A, Nilsson P, Janzon L, Berglund G. Rosiglitazone and carotid IMT progression rate in a mixed cohort of patients with type 2 diabetes and the insulin resistance syndrome: main results from the Rosiglitazone Atherosclerosis Study. J Intern Med. 2007 Mar;261(3):293-305. doi: 10.1111/j.1365-2796.2007.01767.x.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in Sweden.
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 1 inclusion and 6 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 1 Sep 2016. 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 Sweden. 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?
Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment. (time frame: 52 weeks). 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 NCT00306644, which also lists 1 linked publication.
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 Sep 2016.