Status:
TERMINATED
GALLANT 6 Tesaglitazar vs. Pioglitazone
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet a...
Eligibility Criteria
Inclusion
- Provision of a written informed consent
- Men or women who are ³18 years of age
- Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
- Diagnosed with type 2 diabetes
- Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
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, neutropenia (low white blood cells)
- Creatinine levels above twice the normal range
- Creatine kinase above 3 times the upper limit of normal
- Received any investigational product in other clinical studies within 12 weeks
- 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 :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
1450 Patients enrolled
Trial Details
Trial ID
NCT00214565
Start Date
August 1 2004
End Date
October 1 2006
Last Update
November 19 2010
Active Locations (74)
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1
Research Site
Altoona, Pennsylvania, United States
2
Research Site
Ciudad de Buenos Aires, Argentina
3
Research Site
Córdoba, Argentina
4
Research Site
Moron- Buenos Aires, Argentina