Last updated: 11/04/2018 03:26:28
Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Effect of rosiglitazone and placebo on carotid intima media thickness in patients with insulin resistance syndrome and/or type 2 diabetes
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment.
Timeframe: 52 weeks
Secondary outcomes:
Plaque occurrence & stenosis within the right carotid artery.
Timeframe: 52 weeks
Interventions:
Drug: Rosiglitazone
Enrollment:
556
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical 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. Journal Of Internal Medicine 2007; 261: 293-305.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
May 2002 to November 2004
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
35 - 80 years
Accepts healthy volunteers
No
- insulin resistant syndrome or Type 2 Diabetes.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- insulin resistant syndrome or Type 2 Diabetes.
Exclusion criteria:
- 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 location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-04-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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