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Clinical Trial Details

Trial ID: L3873
Source ID: NCT00229710
Associated Drug: Tesaglitazar
Title: GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 Diabetes
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Tesaglitazar
Outcome Measures: Primary: Adverse events|Laboratory variables|Physical examination|Cardiac evaluation|Hypoglycemic events|Electrocardiogram|Vital signs (blood pressure and pulse)|Body weight | Secondary: Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c|Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)|Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C|C-reactive protein (CRP)|Central obesity (waist circumference, hip circumference, waist/hip ratio)
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 270
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2005-02
Completion Date: 2006-12
Results First Posted:
Last Update Posted: 2010-11-19
Locations: Research Site, Birmingham, Alabama, United States|Research Site, Phoenix, Arizona, United States|Research Site, Tucson, Arizona, United States|Research Site, Fresno, California, United States|Research Site, Greenbrae, California, United States|Research Site, La Jolla, California, United States|Research Site, Northridge, California, United States|Research Site, Riverside, California, United States|Research Site, San Diego, California, United States|Research Site, Santa Monica, California, United States|Research Site, Spring Valley, California, United States|Research Site, Walnut Creek, California, United States|Research Site, West Hills, California, United States|Research Site, Waterbury, Connecticut, United States|Research Site, Washington, District of Columbia, United States|Research Site, Gainesville, Florida, United States|Research Site, Hollywood, Florida, United States|Research Site, Jacksonville, Florida, United States|Research Site, Miami, Florida, United States|Research Site, Orlando, Florida, United States|Research Site, Palm Harbor, Florida, United States|Research Site, West Palm Beach, Florida, United States|Research Site, Augusta, Georgia, United States|Research Site, Dunwoody, Georgia, United States|Research Site, Boise, Idaho, United States|Research Site, Chicago Heights, Illinois, United States|Research Site, Chicago, Illinois, United States|Research Site, Gurnee, Illinois, United States|Research Site, Springfield, Illinois, United States|Research Site, Indianapolis, Indiana, United States|Research Site, Wichita, Kansas, United States|Research Site, New Orleans, Louisiana, United States|Research Site, Baltimore, Maryland, United States|Research Site, Cadillac, Michigan, United States|Research Site, Richmond Heights, Missouri, United States|Research Site, St. Louis, Missouri, United States|Research Site, Omaha, Nebraska, United States|Research Site, North Las Vegas, Nevada, United States|Research Site, Pahrump, Nevada, United States|Research Site, Dover, New Hampshire, United States|Research Site, Albuquerque, New Mexico, United States|Research Site, Brooklyn, New York, United States|Research Site, New Hyde Park, New York, United States|Research Site, Charlotte, North Carolina, United States|Research Site, Wilmington, North Carolina, United States|Research Site, Cincinnati, Ohio, United States|Research Site, Kettering, Ohio, United States|Research Site, Toledo, Ohio, United States|Research Site, Oklahoma City, Oklahoma, United States|Research Site, Medford, Oregon, United States|Research Site, Portland, Oregon, United States|Research Site, Altoona, Pennsylvania, United States|Research Site, Cheswick, Pennsylvania, United States|Research Site, Erie, Pennsylvania, United States|Research Site, Philadelphia, Pennsylvania, United States|Research Site, Columbia, South Carolina, United States|Research Site, Greer, South Carolina, United States|Research Site, Corpus Christi, Texas, United States|Research Site, Dallas, Texas, United States|Research Site, Fort Worth, Texas, United States|Research Site, Houston, Texas, United States|Research Site, Roseland, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, Richmond, Virginia, United States|Research Site, Bellevue, Washington, United States|Research Site, Renton, Washington, United States|Research Site, Spokane, Washington, United States|Research Site, Tacoma, Washington, United States|Research Site, Madison, Wisconsin, United States
URL: https://clinicaltrials.gov/show/NCT00229710