GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
2 other identifiers
interventional
500
4 countries
110
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started Apr 2002
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 20, 2006
CompletedFirst Posted
Study publicly available on registry
January 24, 2006
CompletedJuly 31, 2006
July 1, 2006
January 20, 2006
July 27, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG)
Secondary Outcomes (9)
Changes in the following variables from baseline to the end of the randomized treatment period:
The change in plasma glucose and insulin during an oral glucose tolerance test
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
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
Change in insulin levels and hemoglobin A1c (HbA1c) levels
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (110)
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
Related Publications (1)
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.
PMID: 17166340DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Galida Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 20, 2006
First Posted
January 24, 2006
Study Start
April 1, 2002
Study Completion
June 1, 2003
Last Updated
July 31, 2006
Record last verified: 2006-07