Status:
TERMINATED
GALLANT 2 Tesaglitazar vs. Placebo
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet an...
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
- 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
- Drug-naïve (ie, no use of antidiabetic drug\[s\] for at least 24 weeks prior to visit 1).
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 :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00252772
Start Date
September 1 2004
End Date
November 1 2006
Last Update
April 22 2009
Active Locations (14)
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1
Research Site
Hanko, Finland
2
Research Site
Helsinki, Finland
3
Research Site
Imatra, Finland
4
Research Site
Jakobstad, Finland