Status:
COMPLETED
GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-50 years
Phase:
PHASE2
Brief Summary
This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in patients with type 2 di...
Eligibility Criteria
Inclusion
- Provision of a written informed consent
- Men or women who are 30 to 80 years of age
- Female patients: postmenopausal or surgically sterile
- Diagnosed with type 2 diabetes with C-peptide levels \> 0.8 ng/mL
- 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), or to other PPAR g or PPAR a and g agonists.
- History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
- Creatinine levels above 1.2 mg/dL
- Received any investigational product in other clinical studies within 30 days
- 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 :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00280865
Start Date
April 1 2002
End Date
June 1 2003
Last Update
July 31 2006
Active Locations (110)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Huntsville, Alabama, United States
3
Research Site
Montgomery, Alabama, United States
4
Research Site
Mesa, Arizona, United States