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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes

Keywords

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Tesaglitazar type 2 diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tesaglitazar

Intervention Type DRUG

Pioglitazone

Intervention Type DRUG

Dietary and Lifestyle Modification Counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Galida Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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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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

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Countries

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United States Canada France Mexico

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.

Reference Type DERIVED
PMID: 17166340 (View on PubMed)

Other Identifiers

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GLAD

Identifier Type: -

Identifier Source: secondary_id

SH-SBD-0001

Identifier Type: -

Identifier Source: org_study_id