Status:
TERMINATED
GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type ...
Eligibility Criteria
Inclusion
- 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 the randomized treatment period in GALLANT 6
Exclusion
- 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 by 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT00226330
Start Date
March 1 2005
End Date
December 1 2006
Last Update
November 19 2010
Active Locations (171)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Birmingham, Alabama, United States
2
Research Site
Columbiana, Alabama, United States
3
Research Site
Mobile, Alabama, United States
4
Research Site
Chandler, Arizona, United States