Status:
TERMINATED
ARMOR (Analyzing Renal Mechanisms of Creatinine Excretion in Patients On tesaglitazaR)
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
45+ years
Phase:
PHASE2
Brief Summary
This is a prospective 24-week, randomized, parallel-group, multi-center, active-controlled (pioglitazone 45 mg) open-label study designed to assess the effects of tesaglitazar 2 mg per day on componen...
Eligibility Criteria
Inclusion
- Provision of a written informed consent
- Men or women who are \>=45 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 :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00229684
Start Date
September 1 2004
End Date
June 1 2006
Last Update
August 30 2011
Active Locations (21)
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1
Research Site
Pasadena, California, United States
2
Research Site
Washington D.C., District of Columbia, United States
3
Research Site
Gainesville, Florida, United States
4
Research Site
Miami, Florida, United States