GALLEX 1 - Long Term Extension Study in patients with Type 2 Diabetes

Exclusion Criteria

• - Type 1 diabetes
• - New York Heart Association heart failure Class III or IV
• - Treatment with chronic insulin
• - History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
• - History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
• - Creatinine levels above twice the normal range
• - Creatine kinase above 3 times the upper limit of normal
• - Previous enrollment in this long-term extension study
• - Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient’s safety or successful participation in the clinical study