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Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT00225342
First received: September 21, 2005
Last updated: September 7, 2006
Last verified: September 2005
History of Changes
  Purpose

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 Intervention Phase
Angina Pectoris
Diabetes Mellitus, Type 2
 Drug: Rosiglitazone
Drug: Gliclazide (Comparison drug)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 NLM:

U.S. FDA Resources

Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • Angina status at 3 months

Secondary Outcome Measures:
  • Pulse wave velocity at 3 months
  • Small vessel function at 3 months
  • Haemostatic markers at 3 months
  • Biochemical markers of inflammation at 3 months

Estimated Enrollment: 60
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225342

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

No publications provided

ClinicalTrials.gov Identifier: NCT00225342     History of Changes
Other Study ID Numbers: GlasUniRosiGlic, Eudract No. 2004-000943-40
Study First Received: September 21, 2005
Last Updated: September 7, 2006
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Glasgow:
Angina
Ischaemic heart disease
Diabetes

Additional relevant MeSH terms:
Angina Pectoris
Diabetes Mellitus
Diabetes Mellitus, Type 2
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
 Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013