GALLEX 4 - Long-Term Extension Study to Evaluate Tesaglitazar Therapy in Patients With Type 2 Diabetes

A Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar Therapy in Patients With Type 2 Diabetes

This is a parallel-group, multi-center, long-term extension study from the GALLANT 4 study to monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including treatment and follow-up, is 103 weeks.

Inclusion Criteria:

• Provision of a written informed consent
• Men or women who are >=18 years of age
• Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
• Completed the last two visits of randomized treatment period in GALLANT 4

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