Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00225342
• Other study ID #: GlasUniRosiGlic
• Secondary ID: Eudract No. 2004
• Status: Withdrawn
• Phase: Phase 4
• First received: September 21, 2005
• Last updated: September 7, 2006

Study information

• Verified date: September 2005
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Rosiglitazone

• Gliclazide (Comparison drug)

Locations

Country	Name	City	State
United Kingdom	Cardiology Department, Glasgow Royal Infirmary	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angina status at 3 months
Secondary	Pulse wave velocity at 3 months
Secondary	Small vessel function at 3 months
Secondary	Haemostatic markers at 3 months
Secondary	Biochemical markers of inflammation at 3 months