Status:
TERMINATED
GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin (along or in combinatio...
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 for less than 20 years and receiving at least 30 U insulin per day
Exclusion
- Type 1 diabetes
- New York Heart Association heart failure Class III or IV
- Treatment with any thiazolidinedione class of antidiabetic agents
- 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 :
March 1 2006
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT00242372
Start Date
August 1 2004
End Date
March 1 2006
Last Update
April 22 2009
Active Locations (71)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Phoenix, Arizona, United States
3
Research Site
Tuscson, Arizona, United States
4
Research Site
Fresno, California, United States