Type 2 DiabetesNCT00255645

G-PLUS (GALLANT, GALLEX and ARMOR - Post Treatment Follow-up Study)

An observational study of Type 2 Diabetes, run by AstraZeneca at 543 sites in 40 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
How many people: 4,500 participants
Where: 543 sitesin 40 countries
Study dates: Sep 2005to Dec 2006
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of a written informed consent
Men or women who either completed at least 6 months in a previous treatment study GALLANT, GALLEX or ARMOR or met a pre-defined laboratory or clinical finding during participation in any of the said studies.

Who cannot join

Received open-label treatment with tesaglitazar (since this is a post-treatment study)

Trial locations and contacts

543 sites in 40 countries.

Country

City, postcode or hospital

543 sites in 40 countries

United States165 sites

Research Site
Albuquerque, New Mexico
Research Site
Altoona, Pennsylvania
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Anaheim, California
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Asheville, North Carolina
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Atlanta, Georgia
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Augusta, Georgia
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Baltimore, Maryland
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Bellevue, Washington
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Berwyn, Illinois
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Birmingham, Alabama
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Boise, Idaho
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Bossier City, Louisiana
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Brandon, Florida
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Brooklyn, New York
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Brunswick, Georgia
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Burke, Virginia
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Cadillac, Michigan
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Carlisle, Arkansas
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Carmichael, California
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Carrollton, Texas
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Chandler, Arizona
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Charlotte, North Carolina
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Cheswick, Pennsylvania
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Chicago, Illinois
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Chicago Heights, Illinois
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Chula Vista, California
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Cincinnati, Ohio
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Clearwater, Florida
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Cleveland, Ohio
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Colorado Springs, Colorado
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Columbia, Maryland
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Columbia, South Carolina
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Columbiana, Alabama
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Columbus, Georgia
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Columbus, Ohio
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Cooper City, Florida
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Corpus Christi, Texas
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Dallas, Texas
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Dayton, Ohio
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Delray Beach, Florida
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Dover, New Hampshire
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Dunwoody, Georgia
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Elk Grove, California
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Elk Grove Village, Illinois
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Encinitas, California
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Encino, California
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Erie, Pennsylvania
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Escondido, California
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Evansville, Indiana
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Excelsior Springs, Missouri
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Flushing, New York
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Fort Worth, Texas
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Fresno, California
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Gainesville, Florida
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Gig Harbor, Washington
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Greenbrae, California
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Greer, South Carolina
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Gurnee, Illinois
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Hamilton, New Jersey
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Haverhill, Massachusetts
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Hialeah, Florida
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Hollywood, Florida
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Honolulu, Hawaii
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Houston, Texas
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Huntington, West Virginia
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Huntington Beach, California
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Indianapolis, Indiana
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Jacksonville, Florida
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Jonesboro, Arkansas
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Kalamazoo, Michigan
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Kettering, Ohio
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La Jolla, California
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Las Vegas, Nevada
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Lexington, Kentucky
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Little Rock, Arkansas
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Loma Linda, California
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Long Beach, California
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Los Angeles, California
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Louisville, Kentucky
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Madison, Wisconsin
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Manlius, New York
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Medford, Oregon
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Melbourne, Florida
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Melrose Park, Illinois
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Memphis, Tennessee
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Menomonee Falls, Wisconsin
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Mesa, Arizona
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Miami, Florida
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Midland, Texas
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Milwaukee, Wisconsin
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Mission Viejo, California
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Mobile, Alabama
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Morristown, Tennessee
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New Hyde Park, New York
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New Orleans, Louisiana
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New York, New York
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Newark, Delaware
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Norfolk, Virginia
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North Chicago, Illinois
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North Las Vegas, Nevada
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North Richland Hills, Texas
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Northridge, California
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Ocoee, Florida
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Oklahoma City, Oklahoma
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Olean, New York
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Omaha, Nebraska
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Orange, California
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Orlando, Florida
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Pahrump, Nevada
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Palm Harbor, Florida
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Pasadena, California
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Peoria, Illinois
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Plantation, Florida
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Pleasantville, New Jersey
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Portland, Oregon
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Reading, Pennsylvania
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Redondo Beach, California
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Reno, Nevada
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Renton, Washington
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Richmond, Virginia
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Richmond Heights, Missouri
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Riverside, California
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Rochester, New York
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Rolla, Missouri
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Roseland, Texas
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Sacramento, California
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Salt Lake City, Utah
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San Antonio, Texas
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San Diego, California
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Santa Ana, California
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Santa Monica, California
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Searcy, Arizona
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Seattle, Washington
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Sherwood, Arkansas
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Sierra Vista, Arizona
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Simpsonville, South Carolina
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Slidell, Louisiana
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Spokane, Washington
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Spring Valley, California
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Springfield, Illinois
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St Louis, Missouri
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Staten Island, New York
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Sterling, Illinois
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Tacoma, Washington
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The Bronx, New York
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Toledo, Ohio
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Topeka, Kansas
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Tucson, Arizona
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Tulsa, Oklahoma
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Tustin, California
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Virginia Beach, Virginia
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Walnut Creek, California
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Warminster, Pennsylvania
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Washington D.C., District of Columbia
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Waterbury, Connecticut
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Waterloo, Iowa
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West Hills, California
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West Palm Beach, Florida
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Wheat Ridge, Colorado
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White Plains, New York
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Wichita, Kansas
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Wilmington, North Carolina
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Winston-Salem, North Carolina

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France41 sites

Research Site
Ambriere Les Vallees
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Angers
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Béziers
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Briey
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Broglie
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Château-Gontier
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Cremeaux
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Fontaine Saint Martin
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Gan
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Hyères
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Jarny
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La Garde
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La Seyne-sur-Mer
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Lambersat
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Laval
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Le Brusc
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Le Lavandou
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Lille
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Lomme
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Marignane
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Mars Da Tour
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Mayenne
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Metz
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Mondelange
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Montbrison
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Montpellier
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Montrevault
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Moûtiers
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Nantes
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Paris
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Poitiers
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Roanne
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Roquevaire
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Saint-Chamond
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Saint-Cyr
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Saint-Jean-de-Luz
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Six-Fours-les-Plages
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Tantonville
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Tiercé
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Toulon
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Toulouse

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Canada35 sites

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Abbotsford British Columbia, British Columbia
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Bay Roberts, Newfoundland and Labrador
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Bolton, Ontario
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Brampton, Ontario
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Calgary, Alberta
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Chicoutimi, Quebec
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Coquitlam, British Columbia
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Edmonton, Alberta
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Etobicoke, Ontario
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Halifax, Nova Scotia
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Hamilton, Ontario
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Hastings, Ontario
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Kingston, Ontario
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Laval, Quebec
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London, Ontario
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Longueuil, Quebec
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Montreal, Quebec
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Mount Pearl, Newfoundland and Labrador
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Napanee, Ontario
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Niagara Falls, Ontario
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North York, Ontario
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Oshawa, Ontario
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Ottawa, Ontario
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Saint Catherines, Ontario
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Scarborough Village, Ontario
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Sherbrooke, Quebec
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Smith Falls, Ontario
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St. John's, Newfoundland and Labrador
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Surrey, British Columbia
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Toronto, Ontario
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Trois-Rivières, Quebec
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Truro, Nova Scotia
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Vancouver, British Columbia
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Windzor, Nova Scotia
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Winnipeg, Manitoba

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United Kingdom31 sites

Research Site
Aberdeen
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Atherstone
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Ayr
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Bath
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Belfast
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Berks
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Birmingham
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Bolton
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Bucks
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Cardiff
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Co Antrim N Ireland
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Co. Wexford, Ireland
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Coventry
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Dublin
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Dundee
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Edinburgh
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Glasgow
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Kent
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Leeds
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Liverpool
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Manchester
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Northampton
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Pembrokeshire
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Plymouth
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Radstock
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Reading
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Shrewsbury
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Surrey
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West Midlands
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Wiltshire
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Wrexham

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Norway24 sites

Research Site
Ås
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Aursmoen
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Bergen
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Elverum
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Enebakk
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Fredrikstad
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Hamar
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Haugesund
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Hønefoss
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Horten
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Inderøy
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Kongsberg
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Larvik
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Lena
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Lierskogen
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Lysaker
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Oslo
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Østerås
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Rolvsøy
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Rud
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Soerumsand
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Stavanger
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Straume
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Germany20 sites

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Aschaffenburg
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Beckum
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Berlin
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Dresden
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Düsseldorf
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Ehrenberg
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Essen
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Gelnhausen
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Hamburg
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Hanover
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Heidelberg
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Heilbronn
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Hermaringen
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Künzing
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Langen
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Mannheim
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Marl
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Nürberg
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Pirna
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Rotenburg/Fulda

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Finland19 sites

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Hämeenlinna
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Helsinki
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Imatra
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Jakobstad
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Joensuu
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Kauniainen
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Kokkola
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Kouvola
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Kuopio
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Lahti
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Mikkeli
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Oulu
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Pori
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Salo
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Tampere
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Turku
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Vantaa

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Italy19 sites

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Arenzano
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Chiavari (GE)
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Florence
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Gubbio (PG)
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Messina
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Milan
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Monteccio Emilia
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Naples
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Padova
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Perugia
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Pescara
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Piacenza
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Pistoia
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Reggio Emilia
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Poland19 sites

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Gdansk
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Lodz
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Lublin
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Poznan
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Radom
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Sopot
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Szczecin
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Slovakia17 sites

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Košice
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Levice
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Sweden14 sites

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Netherlands10 sites

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Spain9 sites

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Australia8 sites

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Hungary8 sites

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Israel8 sites

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Belgium7 sites

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Latvia7 sites

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About this study

Official title: A Long-Term, Post-Treatment, Safety Follow-Up, Multi-Center Study in Patients With Type 2 Diabetes Mellitus From the GALLANT, GALLEX or ARMOR Studies.

This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24 months, in patients with type 2 diabetes after participation in the phaseII/III studies GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined laboratory or clinical findings, will have a 12-week post-treatment follow-up visit, including laboratory evaluation and adverse event recording.

Conditions: Type 2 Diabetes
Medical subject headings: Diabetes Mellitus, Type 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Dec 2006

First posted21 Nov 2005 (estimated)
Study startSep 2005
Study completionDec 2006

Why it stopped: The development program has been terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 4,500 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00255645
Sponsor's protocol ID: D6160C00056
Other IDs: EudraCT No 2005-001373-97
Status last verified: Mar 2008
First submitted: 18 Nov 2005
Last updated: 17 Mar 2008
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-Term, Post-Treatment, Safety Follow-Up, Multi-Center Study in Patients With Type 2 Diabetes Mellitus From the GALLANT, GALLEX or ARMOR Studies.
ClinicalTrials.gov ID: NCT00255645
Acronym / sponsor ID: D6160C00056
Conditions: Type 2 Diabetes
Study type: Observational
Recruitment status: TerminatedReason stopped: The development program has been terminated
Enrolment: 4,500 participants
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2005
Study completion: Dec 2006 (actual)
First posted: 21 Nov 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Provision of a written informed consent
Men or women who either completed at least 6 months in a previous treatment study GALLANT, GALLEX or ARMOR or met a pre-defined laboratory or clinical finding during participation in any of the said studies.

Key exclusion criteria (1 listed)

Received open-label treatment with tesaglitazar (since this is a post-treatment study)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Not reported in the source record.

Results and safety

The study was stopped early (reason given: The development program has been terminated). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2008.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstrasZeneca Galida Medical Science Director, MD study director

AstraZeneca

543 sites in 40 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by AstraZeneca at 543 sites in 40 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 543 sites in United States, France, Canada, United Kingdom, Norway and 35 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The development program has been terminated). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00255645.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2008.