Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225342
Status:
WITHDRAWN
Last Update Posted:
2006-09-08
First Post:
2005-09-21
Brief Title:
Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina
Sponsor:
University of Glasgow
Organization:
University of Glasgow
Study Overview
Official Title:
Effects of Rosiglitazone and Sulphonylureas on Ischaemic Burden Blood Pressure and Novel Risk Markers Inclusive of Vascular Function in Patients With Chronic Stable Angina and Type 2 Diabetes Mellitus A Randomised Double-Blinded Study
Status:
WITHDRAWN
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Angina status will be measured via exercise tolerance testing 24-hour ECG testing and angina quality of life questionnaire
Angina status will be measured via exercise tolerance testing 24-hour ECG testing and angina quality of life questionnaire
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 improve cardiovascular mortality or morbidity Chronic stable angina is a common problem in patients with type 2 diabetes mellitus
We postulate that in subjects with uncontrolled type 2 diabetes mellitus Hba1c 75 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
We postulate that in subjects with uncontrolled type 2 diabetes mellitus Hba1c 75 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eudract No 2004-000943-40 | None | None | None |