Status:
TERMINATED
ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
Brief Summary
This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2 diabetes. After a 1-wee...
Eligibility Criteria
Inclusion
- Provision of a written informed consent
- Men or women who are 30-70 years of age
- Female patients: postmenopausal, hysterectomized
- 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 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00263965
Start Date
August 1 2005
End Date
July 1 2006
Last Update
March 17 2008
Active Locations (3)
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1
Research Site
Helsinki, Finland
2
Research Site
Pisa, Italy
3
Research Site
Oxford, United Kingdom