GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 Diabetes
NCT ID: NCT00229710
Last Updated: 2010-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
270 participants
INTERVENTIONAL
2005-02-28
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Tesaglitazar
0.5 in combination with insulin (with or without other oral antidiabetic drugs)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Completed the last two visits of the randomized treatment period in GALLANT 9
Exclusion Criteria
* 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, or neutropenia (low white blood cells)
* Creatinine levels of above twice the normal range
* Creatine kinase of above 3 times the upper limit of normal
* Previous enrollment in this long-term extension study
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Galida Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Fresno, California, United States
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Greenbrae, California, United States
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La Jolla, California, United States
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Northridge, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Spring Valley, California, United States
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Walnut Creek, California, United States
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West Hills, California, United States
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Waterbury, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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West Palm Beach, Florida, United States
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Augusta, Georgia, United States
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Dunwoody, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Chicago Heights, Illinois, United States
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Gurnee, Illinois, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Cadillac, Michigan, United States
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Richmond Heights, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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North Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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Dover, New Hampshire, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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New Hyde Park, New York, United States
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Charlotte, North Carolina, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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Kettering, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
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Cheswick, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greer, South Carolina, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Roseland, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Renton, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
Countries
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Other Identifiers
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D6160C00049
Identifier Type: -
Identifier Source: org_study_id