Status:
COMPLETED
Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus
Lead Sponsor:
GlaxoSmithKline
Conditions:
Non-insulin-dependent Diabetes Mellitus
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
Brief Summary
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 wil...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00231387
Start Date
September 1 2002
End Date
May 1 2005
Last Update
January 23 2017
Active Locations (1)
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1
GSK Clinical Trials Call Center
London, United Kingdom, W2 1NY