GALLANT 5 Tesaglitazar Versus Metformin

NCT ID: NCT00214591

Last Updated: 2010-11-19

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-12-31

Brief Summary

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This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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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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GALIDA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of a written informed consent
* Men or women who are ³18 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Diagnosed with type 2 diabetes
* 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), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* 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

18 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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Columbiana, Alabama, United States

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Mobile, Alabama, United States

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Carlisle, Arizona, United States

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Research Center

Sherwood, Arizona, United States

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Chula Vista, California, United States

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Escondido, California, United States

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Huntington Beach, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Orange, California, United States

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Pasadena, California, United States

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Pomona, California, United States

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Redondo Beach, California, United States

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Sacramento, California, United States

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Colorado Springs, Colorado, United States

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Wheat Ridge, Colorado, United States

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Clearwater, Florida, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Brunswick, Georgia, United States

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Carollton, Georgia, United States

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Honolulu, Hawaii, United States

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Boise, Idaho, United States

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Evansville, Indiana, United States

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Kansas City, Kansas, United States

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Overland Park, Kansas, United States

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Witchita, Kansas, United States

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Bossier City, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Kalamazoo, Missouri, United States

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Las Vegas, Nevada, United States

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Hamilton, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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New York, New York, United States

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Pahrump, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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White Plains, New York, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Simpsonville, South Carolina, United States

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Morristown, Tennessee, 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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San Antonio, Texas, United States

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Burke, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Menomonee Falls, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Hämeenlinna, , Finland

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Helsinki, , Finland

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Joensuu, , Finland

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Kouvola, , Finland

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Kuopio, , Finland

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Mikkeli, , Finland

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Oulu, , Finland

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Salo, , Finland

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Tampere, , Finland

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Vantaa, , Finland

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Aschaffenburg, , Germany

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Bad Segeberg, , Germany

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Beckum, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Ehrenberg, , Germany

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Essen, , Germany

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Feldafing, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Hermaringen, , Germany

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Künzing, , Germany

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Langen, , Germany

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Mannheim, , Germany

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Marl, , Germany

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Nuremberg, , Germany

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Pirna, , Germany

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Rotenburg/Fulda, , Germany

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Ashkelon, , Israel

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Rishon LeZiyyon, , Israel

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Safed, , Israel

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Tel Aviv, , Israel

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Beek en Donk, , Netherlands

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Bennebroe, , Netherlands

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Deurne, , Netherlands

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Huizen, , Netherlands

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Losser, , Netherlands

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Nijverdal, , Netherlands

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Rijswijk, , Netherlands

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Roelofarendsveen, , Netherlands

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Rotterdam, , Netherlands

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The Hague, , Netherlands

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Bergen, , Norway

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Oslo, , Norway

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Østerås, , Norway

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San Vicente de Raspeig, Alicante, Spain

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Villar del Arzobispo, Valencia, Spain

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Alzira (Valencia), , Spain

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Barcelona, , Spain

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Begonte (Lugo), , Spain

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Madrid, , Spain

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Seville, , Spain

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Aberdeen, , United Kingdom

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Ayr, , United Kingdom

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Bath, , United Kingdom

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Berks, , United Kingdom

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Bucks, , United Kingdom

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Coventry, , United Kingdom

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Dundee, , United Kingdom

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Glasgow, , United Kingdom

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Manchester, , United Kingdom

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Northampton, , United Kingdom

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Wiltshire, , United Kingdom

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Countries

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United States Finland Germany Israel Netherlands Norway Spain United Kingdom

Other Identifiers

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D6160C00029

Identifier Type: -

Identifier Source: org_study_id