Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina
NCT ID: NCT00225342
Last Updated: 2006-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
60 participants
INTERVENTIONAL
Brief Summary
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Angina status will be measured via exercise tolerance testing, 24-hour ECG testing and angina quality of life questionnaire.
Detailed Description
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We postulate that in subjects with uncontrolled type 2 diabetes mellitus (Hba1c \>7.5%), on metformin therapy, and chronic stable angina that the addition of the insulin sensitiser, rosiglitazone to control their diabetes will improve their angina when compared to the addition of the hypoglycaemic agent gliclazide. This hypothesis is based on the fact that insulin resistance is an upstream mechanism common to both conditions.
We will randomise such patients to 3 months therapy of rosiglitazone or gliclazide for 3 months, comparing angina status before and after by way of full Bruce protocol exercise testing, 24 hour ST segment analysis and angina questionnaire.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Rosiglitazone
Gliclazide (Comparison drug)
Eligibility Criteria
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Inclusion Criteria
* Participants will have uncontrolled diabetes (Hba1c\>7.5) on metformin monotherapy (so the diabetes is not over treated)
* Participants will be diabetic for less than 8 years.
Exclusion Criteria
* Hepatic Impairment (ALT\>70U/l, AST\>80U/l)
* Any clinical signs of heart failure
* Physical disability precluding treadmill exercise tolerance testing
* Abnormal resting ECG (left or right bundle-branch block, left or right ventricular hypertrophy, ventricular preexcitation, Q-wave myocardial infarction, digitalis therapy)
* Women of childbearing potential
* Women who are breastfeeding
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
University of Glasgow
OTHER
Principal Investigators
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Naveed Sattar, MBChB PhD
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Stuart M Cobbe, MBChB MD
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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Cardiology Department, Glasgow Royal Infirmary
Glasgow, , United Kingdom
Countries
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Other Identifiers
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Eudract No. 2004-000943-40
Identifier Type: -
Identifier Source: secondary_id
GlasUniRosiGlic
Identifier Type: -
Identifier Source: org_study_id