A Phase 3 interventional study of rosiglitazone in Non-insulin-dependent Diabetes Mellitus, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-23.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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.
Time frame: 52 Weeks
These include magnetic resonance endpoints related to plaque lipid content, volume, plaque size and fibrous cap thickness. Colour duplex measurements, laboratory assays for glycaemia and lipids.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline