Status:
TERMINATED
GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes dur...
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 9
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 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00229710
Start Date
February 1 2005
End Date
December 1 2006
Last Update
November 19 2010
Active Locations (69)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Phoenix, Arizona, United States
3
Research Site
Tucson, Arizona, United States
4
Research Site
Fresno, California, United States