Status:
WITHDRAWN
Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina
Lead Sponsor:
University of Glasgow
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Angina Pectoris
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The principle objective of the trial is to compare rosiglitazone to gliclazide in patients with type 2 diabetes mellitus and chronic stable angina to see how the subjects' angina status changes. Angi...
Detailed Description
Ischaemic heart disease is one of the main complications of type 2 diabetes mellitus, both in terms of morbidity and mortality. Reducing plasma glucose with hypoglycaemic agents has not been shown to ...
Eligibility Criteria
Inclusion
- Chronic stable angina with ongoing symptoms. (The treatment goal being an improvement in symptoms)
- 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
- Renal impairment (creatinine \>130mmol/l)
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00225342
Last Update
September 8 2006
Active Locations (1)
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1
Cardiology Department, Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF