GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy 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, or neutropenia (low white blood cells)
• - Creatinine levels of above twice the normal range
• - Creatine kinase of 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