Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Glasgow
• Collaborator: GlaxoSmithKline
• Treatments: Gliclazide; Rosiglitazone

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