Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
310 participants
INTERVENTIONAL
2009-01-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo + pioglitazone (with or without metformin)
Placebo albiglutide weekly injection + pioglitazone (with or without metformin)
placebo
placebo weekly subcutaneous injection
albiglutide + pioglitazone (with or without metformin)
albiglutide weekly injection + pioglitazone (with or without meformin)
albiglutide
albiglutide weekly subcutaneous injection
Interventions
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albiglutide
albiglutide weekly subcutaneous injection
placebo
placebo weekly subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* BMI 20-45kg/m2
Exclusion Criteria
* females who are pregnant, lactating, or less than 6 weeks post-partum
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Port Glasgow, Renfrewshire, United Kingdom
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Coventry, West Midlands, United Kingdom
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Glasgow, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Alabaster, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Hueytown, Alabama, United States
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Mobile, Alabama, United States
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Tuscaloosa, Alabama, United States
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Chandler, Arizona, United States
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Gilbert, Arizona, United States
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Green Valley, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Bull Shoals, Arkansas, United States
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Harrisburg, Arkansas, United States
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Hot Springs, Arkansas, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Searcy, Arkansas, United States
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Buena Park, California, United States
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Carmichael, California, United States
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Chula Vista, California, United States
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Foothill Ranch, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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Huntington Beach, California, United States
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Huntington Beach, California, United States
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Indio, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Lakewood, California, United States
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Long Beach, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Los Angeles, 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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Northridge, California, United States
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Palm Desert, California, United States
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Palm Springs, California, United States
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Pasadena, California, United States
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Poway, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Satna Monica, California, United States
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Tarzana, California, United States
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Torrance, California, United States
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Tustin, California, United States
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Victorville, California, United States
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Walnut Creek, California, United States
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West Hills, California, United States
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Arvada, Colorado, United States
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Denver, Colorado, United States
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New Britain, Connecticut, United States
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Trumbull, Connecticut, United States
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Waterbury, Connecticut, United States
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Middletown, Delaware, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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Cocoa, Florida, United States
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Cutler Bay, Florida, United States
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Deerfield Beach, Florida, United States
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Delray Beach, Florida, United States
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Edgewater, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Hallandale, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Lauderdale Lakes, Florida, United States
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Marianna, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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North Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Oviedo, Florida, United States
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Panama City, Florida, United States
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Pembroke Pines, Florida, United States
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Pembroke Pines, Florida, United States
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Plantation, Florida, United States
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Ponte Verda, Florida, United States
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Saint Cloud, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Blue Ridge, Georgia, United States
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Columbus, Georgia, United States
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Decatur, Georgia, United States
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Savannah, Georgia, United States
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Savannah, Georgia, United States
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Snellville, Georgia, United States
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Stone Mountain, Georgia, United States
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Tucker, Georgia, United States
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Honolulu, Hawaii, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Evergreen Park, Illinois, United States
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La Grange, Illinois, United States
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Naperville, Illinois, United States
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Peoria, Illinois, United States
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Avon, Indiana, United States
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Evansville, Indiana, United States
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Fishers, Indiana, United States
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Indianapolis, Indiana, United States
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La Porte, Indiana, United States
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Lafayette, Indiana, United States
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South Bend, Indiana, United States
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Council Bluffs, Iowa, United States
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Des Moines, Iowa, United States
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Dubuque, Iowa, United States
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Iowa City, Iowa, United States
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Waterloo, Iowa, United States
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Arkansas City, Kansas, United States
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Mission, Kansas, United States
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Newton, Kansas, United States
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Overland Park, Kansas, United States
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Topeka, Kansas, United States
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Crescent Springs, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Paducah, Kentucky, United States
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Covington, Louisiana, United States
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Lake Charles, Louisiana, United States
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Shreveport, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Hyattsville, Maryland, United States
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Oxon Hill, Maryland, United States
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Haverhill, Massachusetts, United States
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Bay City, Michigan, United States
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Benzonia, Michigan, United States
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Bloomfield Hills, Michigan, United States
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Dearborn, Michigan, United States
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Interlochen, Michigan, United States
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Kalamazoo, Michigan, United States
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Kalamazoo, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Minneapolis, Minnesota, United States
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Gulfport, Mississippi, United States
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Picayune, Mississippi, United States
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Rolling Fork, Mississippi, United States
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Chesterfield, Missouri, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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West Plains, Missouri, United States
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Billings, Montana, United States
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Butte, Montana, United States
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Great Falls, Montana, United States
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Broken Bow, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
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Elizabeth, New Jersey, United States
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Haddon Heights, New Jersey, United States
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Hainesport, New Jersey, United States
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Stratford, New Jersey, United States
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New York, New York, United States
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North Massapequa, New York, United States
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Asheboro, North Carolina, United States
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Asheville, North Carolina, United States
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Burlington, North Carolina, United States
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Calabash, North Carolina, United States
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Chadbourn, North Carolina, United States
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Durham, North Carolina, United States
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Fayetteville, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Lenoir, North Carolina, United States
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Mint Hill, North Carolina, United States
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Morehead City, North Carolina, United States
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Shelby, North Carolina, United States
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Tabor City, North Carolina, United States
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Akron, Ohio, United States
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Canal Fulton, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Kettering, Ohio, United States
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Mason, Ohio, United States
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Maumee, Ohio, United States
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Thornville, Ohio, United States
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Zanesville, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Ashland, Oregon, United States
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Bensalem, Pennsylvania, United States
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Carlisle, Pennsylvania, United States
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Downington, Pennsylvania, United States
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Feasterville, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Landsdale, Pennsylvania, United States
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Melrose Park, Pennsylvania, United States
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Tipton, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Cumberland, Rhode Island, United States
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East Providence, Rhode Island, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Greenville, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Murrells Inlet, South Carolina, United States
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North Myrtle Beach, South Carolina, United States
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Orangeburg, South Carolina, United States
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Simpsonville, South Carolina, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Clarksville, Tennessee, United States
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Columbia, Tennessee, United States
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Crossville, Tennessee, United States
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Fayetteville, Tennessee, United States
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Germantown, Tennessee, United States
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Johnson City, Tennessee, United States
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McKenzie, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Tullahoma, Tennessee, United States
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Arlington, Texas, United States
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Bedford, Texas, United States
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Cleburne, Texas, United States
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Corpus Christi, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Deer Park, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Hurst, Texas, United States
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Katy, Texas, United States
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Lake Jackson, Texas, United States
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Lewisville, Texas, United States
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Midland, Texas, United States
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North Richland Hills, Texas, United States
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Odessa, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Schertz, Texas, United States
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Sugar Land, Texas, United States
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Sugarland, Texas, United States
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Bountiful, Utah, United States
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Orem, Utah, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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West Jordan, Utah, United States
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West Valley City, Utah, United States
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South Burlington, Vermont, United States
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Burke, Virginia, United States
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Hampton, Virginia, United States
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Manassas, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Suffolk, Virginia, United States
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Weber City, Virginia, United States
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Federal Way, Washington, United States
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Renton, Washington, United States
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Richland, Washington, United States
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Selah, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Lewisburg, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Aurangabad, , India
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Pune, , India
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Arequipa, Arequipa, Peru
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Lima, Lima Province, Peru
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El Agustino, Lima region, Peru
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Huacho, Lima region, Peru
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Trujillo, , Peru
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Port Elizabeth, Eastern Cape, South Africa
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Phoenix, KwaZulu-Natal, South Africa
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Kempton Park, , South Africa
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Somerset West, , South Africa
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Seongnam-si, , South Korea
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Suwon, Kyonggi-do, , South Korea
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Canterbury, Kent, United Kingdom
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Blackpool, Lancashire, United Kingdom
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Sunbury-on-Thames, Middlesex, United Kingdom
Countries
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References
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Home PD, Ahren B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15.
Study Documents
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Document Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Other Identifiers
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112755
Identifier Type: -
Identifier Source: org_study_id
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