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Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00225342
Recruitment Status : Withdrawn
First Posted : September 23, 2005
Last Update Posted : September 8, 2006
Information provided by:
University of Glasgow

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.

Condition or disease Intervention/treatment Phase
Angina Pectoris Diabetes Mellitus, Type 2 Drug: Rosiglitazone Drug: Gliclazide (Comparison drug) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Primary Outcome Measures :
  1. Angina status at 3 months

Secondary Outcome Measures :
  1. Pulse wave velocity at 3 months
  2. Small vessel function at 3 months
  3. Haemostatic markers at 3 months
  4. Biochemical markers of inflammation at 3 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00225342

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United Kingdom
Cardiology Department, Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Sponsors and Collaborators
University of Glasgow
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Principal Investigator: Naveed Sattar, MBChB PhD University of Glasgow
Principal Investigator: Stuart M Cobbe, MBChB MD University of Glasgow

Layout table for additonal information Identifier: NCT00225342    
Other Study ID Numbers: GlasUniRosiGlic
Eudract No. 2004-000943-40
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: September 2005
Keywords provided by University of Glasgow:
Ischaemic heart disease
Additional relevant MeSH terms:
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Angina Pectoris
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs