Last updated: 11/04/2018 05:43:51
Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus
GSK study ID
BRL-049563/351
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Rosiglitazone and Plaque Study: A 12 Month Randomised, Double-blind, Placebo-controlled, Magnetic Resonance Imaging Study to Evaluate the Effect of Rosiglitazone on the Structure and Composition of Carotid Atherosclerotic Plaques in Subjects with Type 2 Diabetes Mellitus and Coexisting Vascular Disease or Hypertension
Trial description: This is a phase IIIb, randomised, double blind, placebo controlled, study in patients with type 2 diabetes mellitus and coexisting vascular disease or hypertension. The total duration of the study will be approximately 60 weeks. The aim of this study is to examine the potential beneficial effects of rosiglitazone on carotid atheroma in patients with type 2 diabetes mellitus and coexisting vascular disease or hypertension. It is hypothesised that treatment with rosiglitazone will lead to an decrease in plaque size. In addition, it is hoped that rosiglitazone will have a positive effect on plaque composition and stability.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
The effect of 52 wks oral treatment with rosiglitazone in comparison to placebo on change from baseline of the plaque total wall volume in the carotid artery, in patients with type 2 dm and vascular disease/hypertension, using cardiac mri.
Timeframe: 52 Weeks
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
60
Primary completion date:
2005-31-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Non-Insulin-Dependent Diabetes Mellitus
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
February 2003 to May 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
30 - 75 Years
Accepts healthy volunteers
No
- Type 2 diabetes.
- Co-existing vascular disease.
- Patients with >2 concomitant oral anti-hyperglycaemic agents within 3 months of screening.
- Previous exposure to a thiazolidinedione.
Inclusion and exclusion criteria
Inclusion criteria:
- Type 2 diabetes.
- Co-existing vascular disease.
- At least 6 months of statin or fibrate therapy.
- HbA1c <10% at screening and with at least one atheromatous plaque causing 10-95% narrowing of the internal carotid artery.
Exclusion criteria:
- Patients with >2 concomitant oral anti-hyperglycaemic agents within 3 months of screening.
- Previous exposure to a thiazolidinedione.
- History of chronic insulin use.
- Use of investigational drug within 30 days.
- Systolic blood pressure (bp) > 170 mmHg or diastolic bp >100 mmHg.
- Severe or unstable angina.
- History of: gangrene, TIA, stroke, hepatic disease, alcohol or drug abuse, surgery of the carotid arteries or claustrophobia.
Trial location(s)
Location
GSK Clinical Trials Call Center
London, N/A, United Kingdom, W2 1NY
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
2005-31-05
Actual study completion date
2005-31-05
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.
Additional information about the trial
Additional information
Not applicable
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