- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00280865
GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
July 27, 2006 updated by: AstraZeneca
Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
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 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period.
The study comprises a 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
500
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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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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Alberta
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Edmonton, Alberta, Canada
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Ontario
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Burlington, Ontario, Canada
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Courtice, Ontario, Canada
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Quebec
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Granby, Quebec, Canada
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Laval, Quebec, Canada
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Andard, France
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Angers, France
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Avrille, France
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Chalonnes-sur-Loire, France
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Montrevault, France
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Segre, France
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Tierce, France
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Colonia Seccion XVI, Mexico
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Colonia Valle, Mexico
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Delegacion Cuauhtemoc, Mexico
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Alabama
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Montgomery, Alabama, United States
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Arizona
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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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California
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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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Connecticut
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Stamford, Connecticut, United States
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Waterbury, Connecticut, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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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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Georgia
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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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Illinois
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Gurnee, Illinois, United States
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Springfield, Illinois, United States
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Indiana
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Kansas
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Wichita, Kansas, United States
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Kentucky
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Louisville, Kentucky, United States
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Louisiana
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New Orleans, Louisiana, United States
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Maine
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Bangor, Maine, United States
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Maryland
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Baltimore, Maryland, United States
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Massachusetts
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Salisbury, Massachusetts, United States
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Worcester, Massachusetts, United States
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Michigan
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Ann Arbor, Michigan, United States
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Cadillac, Michigan, United States
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Mississippi
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Jackson, Mississippi, United States
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Missouri
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St. Louis, Missouri, United States
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Nebraska
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Omaha, Nebraska, United States
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Nevada
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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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New Jersey
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Lawrenceville, New Jersey, United States
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Newark, New Jersey, United States
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New York
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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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North Carolina
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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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Ohio
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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
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Oklahoma City, Oklahoma, United States
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Oregon
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Eugene, Oregon, United States
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Pennsylvania
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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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Rhode Island
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Warwick, Rhode Island, United States
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South Carolina
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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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South Dakota
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Sioux Falls, South Dakota, United States
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Texas
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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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Utah
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Salt Lake City, Utah, United States
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Virginia
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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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Washington
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Edmonds, Washington, United States
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Renton, Washington, United States
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West Virginia
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Huntington, West Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG)
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Secondary Outcome Measures
Outcome Measure |
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Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
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Pharmacokinetics of tesaglitazar
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Changes in the following variables from baseline to the end of the randomized treatment period:
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The change in plasma glucose and insulin during an oral glucose tolerance test
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Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids
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Change in insulin levels and hemoglobin A1c (HbA1c) levels
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Responder analyses for FPG, TG, and HDL C according to pre-specified values
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To assess the burden of type 2 diabetes mellitus in patients through the administration of the SF-36 health survey and the Well-Being Questionnaire (W BQ12) and comparing the study population data to published national and international normative data
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To evaluate diabetes-specific instruments, Audit of Diabetes Dependent Quality of Life (ADDQoL) and The Diabetes Treatment Satisfaction Questionnaire (DTSQ) (s and c) in the study population and estimate the effect size of the instruments in patients r
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Study Completion
June 1, 2003
Study Registration Dates
First Submitted
January 20, 2006
First Submitted That Met QC Criteria
January 20, 2006
First Posted (Estimate)
January 24, 2006
Study Record Updates
Last Update Posted (Estimate)
July 31, 2006
Last Update Submitted That Met QC Criteria
July 27, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SH-SBD-0001
- GLAD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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