Clinical trial NCT00225342: Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Angina Pectoris
Diabetes Mellitus, Type 2
Keywords: Angina
Ischaemic heart disease
Diabetes
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \>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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Angina status at 3 months
Secondary outcomes:
measure: Pulse wave velocity at 3 months
measure: Small vessel function at 3 months
measure: Haemostatic markers at 3 months
measure: Biochemical markers of inflammation at 3 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Cardiology Department, Glasgow Royal Infirmary
Study officials:
affiliation: University of Glasgow
name: Naveed Sattar, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Stuart M Cobbe, MBChB MD
role: PRINCIPAL_INVESTIGATOR
References: