Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes

Exclusion Criteria

• •Type 1 diabetes and/or history of diabetic ketoacidosis.
• •Exposure to a TZD or other PPAR-g agonist within the 6 months prior to screening visit.
• •Subjects treated with triple OAD therapy or high dose dual combination OAD therapy \[1\].
• •Subjects who have required chronic insulin use in the last 6 months (except during pregnancy or acute episodes such as hospitalization, trauma or infection).
• •ST segment elevation myocardial infarction in the last 30 days.
• •Subjects who have a history or are scheduled to receive coronary artery bypass graft surgery (CABG), valve repair or replacement, aneurysmectomy or planned major non-cardiac surgery during the study period.
• •Subjects who have severe cardiac valvular disease
• •Stroke or resuscitated in the past 6 months
• •History of congestive heart failure (NYHA class I - IV)
• •History of significant hypersensitivity or reaction (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to any TZD, SU, biguanide or insulin
• •Prior history of severe edema or edema requiring medical treatment.
• •Chronic disease requiring chronic or intermittent treatment with oral, intravenous, or injected corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
• •Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
• •Untreated hypo- or hyperthyroidism
• •A diagnosis of cancer (other than superficial squamous, basal cell skin cancer, or adequately treated cervical carcinoma in situ) in the past 3 years or current treatment for the active cancer.
• •Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgement of the Investigator, would preclude safe completion of the study.
• •Blood pressure: SBP \>170 or DBP \> 100 mmHg
• •Significant anemia (Hemoglobin \< 11 g/dL for males and \< 10 g/dL for females).
• •Significant renal disease manifested by serum creatinine (\> 1.5mg/dL for males or \> 1.4mg/dL for females), or where the use of metformin is contra-indicated.
• •Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 2.5 times upper limit of normal (ULN) or bilirubin \>2x ULN).
• •History of myopathy or history of elevated creatine kinase (CK) \> 3 times upper normal limit.
• •Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer).
• •Women who are lactating, pregnant or planning to become pregnant during the course of the study.
• •Unwillingness or inability to comply with the procedures described in this protocol.