GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
NCT ID: NCT00280865
Last Updated: 2006-07-31
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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COMPLETED
PHASE2
500 participants
INTERVENTIONAL
2002-04-30
2003-06-30
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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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Tesaglitazar
Pioglitazone
Dietary and Lifestyle Modification Counseling
Eligibility Criteria
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Inclusion Criteria
* 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 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), 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
30 Years
50 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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Huntsville, Alabama, United States
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Montgomery, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Alhambra, California, United States
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Anaheim, California, United States
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Dinuba, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Greenbrae, California, United States
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Long Beach, California, United States
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Mission Viejo, California, United States
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Orange, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Walnut Creek, California, United States
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Stamford, Connecticut, 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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Brandon, Florida, United States
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Coral Gables, Florida, United States
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DeLand, Florida, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Blue Ridge, Georgia, United States
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Dunwoody, Georgia, United States
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Gurnee, Illinois, United States
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Springfield, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Bangor, Maine, United States
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Baltimore, Maryland, United States
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Salisbury, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Cadillac, Michigan, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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Lawrenceville, New Jersey, United States
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Newark, New Jersey, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canfield, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Kettering, Ohio, United States
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Lakewood, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Altoona, Pennsylvania, United States
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Cheswick, Pennsylvania, United States
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Penndel, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Warminster, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Columbia, South Carolina, United States
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Ninety Six, South Carolina, United States
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Summerville, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Arlington, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Lubbock, Texas, United States
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North Richland Hills, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Falls Church, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Edmonds, Washington, United States
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Renton, Washington, United States
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Huntington, West Virginia, United States
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Edmonton, Alberta, Canada
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Burlington, Ontario, Canada
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Courtice, Ontario, Canada
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Granby, Quebec, Canada
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Laval, Quebec, Canada
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Longueuil, , Canada
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Montreal, , Canada
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Sherbrooke, , Canada
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Windsor, , Canada
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Winnipeg, , Canada
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Andard, , France
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Angers, , France
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Avrillé, , France
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Chalonnes-sur-Loire, , France
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Montrevault, , France
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Segré, , France
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Tiercé, , France
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Colonia del Valle, , Mexico
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Colonia Seccion XVI, , Mexico
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Delegacion Cuauhtemoc, , Mexico
Countries
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References
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Goldstein BJ, Rosenstock J, Anzalone D, Tou C, Ohman KP. Effect of tesaglitazar, a dual PPAR alpha/gamma agonist, on glucose and lipid abnormalities in patients with type 2 diabetes: a 12-week dose-ranging trial. Curr Med Res Opin. 2006 Dec;22(12):2575-90. doi: 10.1185/030079906x154169.
Other Identifiers
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GLAD
Identifier Type: -
Identifier Source: secondary_id
SH-SBD-0001
Identifier Type: -
Identifier Source: org_study_id