A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
A Randomized, Double-blind, Placebo and Active-Controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
685
9 countries
358
Brief Summary
The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Feb 2009
Longer than P75 for phase_3 diabetes-mellitus-type-2
358 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 5, 2009
CompletedFirst Posted
Study publicly available on registry
February 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
July 1, 2014
CompletedJanuary 9, 2017
November 1, 2016
2.9 years
February 5, 2009
April 24, 2014
November 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained \>14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.
Baseline and Week 52
Secondary Outcomes (8)
Change From Baseline in HbA1c at Week 104 and Week 156
Baseline, Week 104, and Week 156
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Baseline and Week 52
Change From Baseline in FPG at Week 104 and Week 156
Baseline, Week 104, and Week 156
Time to Hyperglycemia Rescue
From the start of study medication until the end of the treatment (up to Week 156)
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52
Week 52
- +3 more secondary outcomes
Study Arms (3)
metformin + glimepiride + pioglitazone + albiglutide placebo
ACTIVE COMPARATORMetformin + glimepiride + pioglitazone + matching albiglutide placebo
metformin + glimepiride + pioglitazone placebo + albiglutide
EXPERIMENTALMetformin + open-label glimepiride + pioglitazone matching placebo + albiglutide
met + glimepiride + pioglitazone placebo + albiglutide placebo
ACTIVE COMPARATORmetformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo
Interventions
albiglutide matching placebo weekly subcutaneous injection
albiglutide weekly subcutaneous injection
metformin
glimepiride
pioglitazone matching placebo
Eligibility Criteria
You may qualify if:
- type 2 diabetes
- BMI 20-45kg/m2 inclusive
You may not qualify if:
- females who are pregnant, lactating, or less than 6 weeks post-partum
- current symptomatic heart failure (NYHA Class II-IV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (358)
GSK Investigational Site
Alabaster, Alabama, 35007, United States
GSK Investigational Site
Birmingham, Alabama, 35205, United States
GSK Investigational Site
Birmingham, Alabama, 35235, United States
GSK Investigational Site
Birmingham, Alabama, 35242, United States
GSK Investigational Site
Dothan, Alabama, 36301, United States
GSK Investigational Site
Mobile, Alabama, 36617, United States
GSK Investigational Site
Tuscaloosa, Alabama, 35406, United States
GSK Investigational Site
Chandler, Arizona, 85225, United States
GSK Investigational Site
Gilbert, Arizona, 85295, United States
GSK Investigational Site
Green Valley, Arizona, 85614, United States
GSK Investigational Site
Phoenix, Arizona, 85023, United States
GSK Investigational Site
Phoenix, Arizona, 85028, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Phoenix, Arizona, 85051, United States
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
Tucson, Arizona, 85745, United States
GSK Investigational Site
Bull Shoals, Arkansas, 72619, United States
GSK Investigational Site
Harrisburg, Arkansas, 72432, United States
GSK Investigational Site
Hot Springs, Arkansas, 71913, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Searcy, Arkansas, 72143, United States
GSK Investigational Site
Buena Park, California, 90620, United States
GSK Investigational Site
Chino, California, 91710, United States
GSK Investigational Site
Chula Vista, California, 91910, United States
GSK Investigational Site
Commerce, California, 90040, United States
GSK Investigational Site
Escondido, California, 92026, United States
GSK Investigational Site
Foothill Ranch, California, 92610, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Fullerton, California, 92835, United States
GSK Investigational Site
Huntington Beach, California, 92646, United States
GSK Investigational Site
Indio, California, 92201, United States
GSK Investigational Site
La Jolla, California, 92037, United States
GSK Investigational Site
Lakewood, California, 90712, United States
GSK Investigational Site
Loma Linda, California, 92354, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Los Alamitos, California, 90720, United States
GSK Investigational Site
Los Angeles, California, 90017, United States
GSK Investigational Site
Los Angeles, California, 90022, United States
GSK Investigational Site
Los Angeles, California, 90025, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Northridge, California, 91325, United States
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Palm Desert, California, 92260, United States
GSK Investigational Site
Palm Springs, California, 92262, United States
GSK Investigational Site
Pasadena, California, 91105, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Sacramento, California, 95825, United States
GSK Investigational Site
Sacramento, California, 95831, United States
GSK Investigational Site
San Diego, California, 92117, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
Santa Ana, California, 92701, United States
GSK Investigational Site
Satna Monica, California, 90404, United States
GSK Investigational Site
Spring Valley, California, 91978, United States
GSK Investigational Site
Tarzana, California, 91356, United States
GSK Investigational Site
Tustin, California, 92780, United States
GSK Investigational Site
Victorville, California, 92395, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
West Hills, California, 91307, United States
GSK Investigational Site
Arvada, Colorado, 80005, United States
GSK Investigational Site
Denver, Colorado, 80209, United States
GSK Investigational Site
New Britain, Connecticut, 06050, United States
GSK Investigational Site
Trumbull, Connecticut, 06611, United States
GSK Investigational Site
Waterbury, Connecticut, 06708, United States
GSK Investigational Site
Middletown, Delaware, 19709, United States
GSK Investigational Site
Boynton Beach, Florida, 33426, United States
GSK Investigational Site
Boynton Beach, Florida, 33437, United States
GSK Investigational Site
Clearwater, Florida, 33756, United States
GSK Investigational Site
Clearwater, Florida, 33765, United States
GSK Investigational Site
Cocoa, Florida, 32927, United States
GSK Investigational Site
Cutler Bay, Florida, 33189, United States
GSK Investigational Site
Deerfield Beach, Florida, 33442, United States
GSK Investigational Site
Delray Beach, Florida, 33445, United States
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Edgewater, Florida, 32132, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Gainesville, Florida, 32605, United States
GSK Investigational Site
Hallandale, Florida, 33009, United States
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Hialeah, Florida, 33012, United States
GSK Investigational Site
Hialeah, Florida, 33013, United States
GSK Investigational Site
Hollywood, Florida, 33023, United States
GSK Investigational Site
Lauderdale Lakes, Florida, 33319, United States
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Marianna, Florida, 32446, United States
GSK Investigational Site
Miami, Florida, 33135, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
North Miami, Florida, 33161, United States
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
Orlando, Florida, 32822, United States
GSK Investigational Site
Ormond Beach, Florida, 32174, United States
GSK Investigational Site
Oviedo, Florida, 32765, United States
GSK Investigational Site
Panama City, Florida, 32401, United States
GSK Investigational Site
Pembroke Pines, Florida, 33026, United States
GSK Investigational Site
Pembroke Pines, Florida, 33027, United States
GSK Investigational Site
Plantation, Florida, 33317, United States
GSK Investigational Site
Ponte Verda, Florida, 32081, United States
GSK Investigational Site
Saint Cloud, Florida, 34769, United States
GSK Investigational Site
St. Petersburg, Florida, 33709, United States
GSK Investigational Site
Tampa, Florida, 33603, United States
GSK Investigational Site
West Palm Beach, Florida, 33401, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Atlanta, Georgia, 30312, United States
GSK Investigational Site
Atlanta, Georgia, 30328, United States
GSK Investigational Site
Atlanta, Georgia, 30338, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Blue Ridge, Georgia, 30513, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Decatur, Georgia, 30032, United States
GSK Investigational Site
Savannah, Georgia, 31406, United States
GSK Investigational Site
Savannah, Georgia, 31419, United States
GSK Investigational Site
Snellville, Georgia, 30078, United States
GSK Investigational Site
Stone Mountain, Georgia, 30088, United States
GSK Investigational Site
Tucker, Georgia, 30084, United States
GSK Investigational Site
Honolulu, Hawaii, 96813, United States
GSK Investigational Site
Honolulu, Hawaii, 96814, United States
GSK Investigational Site
Boise, Idaho, 83702, United States
GSK Investigational Site
Idaho Falls, Idaho, 83404, United States
GSK Investigational Site
Aurora, Illinois, 60504, United States
GSK Investigational Site
Chicago, Illinois, 60607, United States
GSK Investigational Site
Evergreen Park, Illinois, 60805, United States
GSK Investigational Site
Gurnee, Illinois, 60031, United States
GSK Investigational Site
La Grange, Illinois, 60525, United States
GSK Investigational Site
Naperville, Illinois, 60564, United States
GSK Investigational Site
Peoria, Illinois, 61602, United States
GSK Investigational Site
Avon, Indiana, 46123, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Fishers, Indiana, 46037, United States
GSK Investigational Site
La Porte, Indiana, 46350, United States
GSK Investigational Site
Lafayette, Indiana, 47904, United States
GSK Investigational Site
South Bend, Indiana, 46614, United States
GSK Investigational Site
Council Bluffs, Iowa, 51501, United States
GSK Investigational Site
Des Moines, Iowa, 50314, United States
GSK Investigational Site
Dubuque, Iowa, 52001, United States
GSK Investigational Site
Iowa City, Iowa, 52243, United States
GSK Investigational Site
Waterloo, Iowa, 50701, United States
GSK Investigational Site
Arkansas City, Kansas, 67005, United States
GSK Investigational Site
Mission, Kansas, 66202, United States
GSK Investigational Site
Newton, Kansas, 67114, United States
GSK Investigational Site
Overland Park, Kansas, 66211, United States
GSK Investigational Site
Topeka, Kansas, 66606, United States
GSK Investigational Site
Fort Mitchell, Kentucky, 41017, United States
GSK Investigational Site
Lexington, Kentucky, 40503, United States
GSK Investigational Site
Lexington, Kentucky, 40504, United States
GSK Investigational Site
Madisonville, Kentucky, 42431, United States
GSK Investigational Site
Paducah, Kentucky, 42003, United States
GSK Investigational Site
Covington, Louisiana, 70433, United States
GSK Investigational Site
Lake Charles, Louisiana, 70601, United States
GSK Investigational Site
Shreveport, Louisiana, 71101, United States
GSK Investigational Site
Shreveport, Louisiana, 71115, United States
GSK Investigational Site
Baltimore, Maryland, 21237-3998, United States
GSK Investigational Site
Hyattsville, Maryland, 20782, United States
GSK Investigational Site
Oxon Hill, Maryland, 20745, United States
GSK Investigational Site
Haverhill, Massachusetts, 01830, United States
GSK Investigational Site
Bay City, Michigan, 48706, United States
GSK Investigational Site
Benzonia, Michigan, 49616, United States
GSK Investigational Site
Bloomfield Hills, Michigan, 48302, United States
GSK Investigational Site
Cadillac, Michigan, 49601, United States
GSK Investigational Site
Dearborn, Michigan, 48124, United States
GSK Investigational Site
Kalamazoo, Michigan, 49009, United States
GSK Investigational Site
Kalamazoo, Michigan, 49048, United States
GSK Investigational Site
Saint Clair Shores, Michigan, 48081, United States
GSK Investigational Site
Minneapolis, Minnesota, 55430, United States
GSK Investigational Site
Gulfport, Mississippi, 39501, United States
GSK Investigational Site
Picayune, Mississippi, 39466, United States
GSK Investigational Site
Rolling Fork, Mississippi, 39159, United States
GSK Investigational Site
Chesterfield, Missouri, 63017, United States
GSK Investigational Site
Jefferson City, Missouri, 65109, United States
GSK Investigational Site
Kansas City, Missouri, 64106, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Springfield, Missouri, 65807, United States
GSK Investigational Site
St Louis, Missouri, 63117, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
West Plains, Missouri, 65775, United States
GSK Investigational Site
Billings, Montana, 59102, United States
GSK Investigational Site
Butte, Montana, 59701, United States
GSK Investigational Site
Great Falls, Montana, 59405, United States
GSK Investigational Site
Broken Bow, Nebraska, 68822, United States
GSK Investigational Site
Lincoln, Nebraska, 68516, United States
GSK Investigational Site
Omaha, Nebraska, 68124, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Las Vegas, Nevada, 89102, United States
GSK Investigational Site
Las Vegas, Nevada, 89104, United States
GSK Investigational Site
Las Vegas, Nevada, 89106, United States
GSK Investigational Site
Las Vegas, Nevada, 89128, United States
GSK Investigational Site
Las Vegas, Nevada, 89130, United States
GSK Investigational Site
Berlin, New Jersey, 08009, United States
GSK Investigational Site
Elizabeth, New Jersey, 07202, United States
GSK Investigational Site
Haddon Heights, New Jersey, 08035, United States
GSK Investigational Site
Hainesport, New Jersey, 08036, United States
GSK Investigational Site
New Brunswick, New Jersey, 08903, United States
GSK Investigational Site
Stratford, New Jersey, 08084, United States
GSK Investigational Site
Albuquerque, New Mexico, 87106, United States
GSK Investigational Site
New York, New York, 10022, United States
GSK Investigational Site
New York, New York, 10025, United States
GSK Investigational Site
North Massapequa, New York, 11758, United States
GSK Investigational Site
Asheboro, North Carolina, 27203, United States
GSK Investigational Site
Asheville, North Carolina, 28803, United States
GSK Investigational Site
Burlington, North Carolina, 27215, United States
GSK Investigational Site
Calabash, North Carolina, 28467, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Fayetteville, North Carolina, 28304, United States
GSK Investigational Site
Greensboro, North Carolina, 27405, United States
GSK Investigational Site
Hickory, North Carolina, 28601, United States
GSK Investigational Site
Huntersville, North Carolina, 28078, United States
GSK Investigational Site
Lenoir, North Carolina, 28645, United States
GSK Investigational Site
Mint Hill, North Carolina, 28227, United States
GSK Investigational Site
Morehead City, North Carolina, 28557, United States
GSK Investigational Site
Shelby, North Carolina, 28150, United States
GSK Investigational Site
Tabor City, North Carolina, 28463, United States
GSK Investigational Site
Akron, Ohio, 44320, United States
GSK Investigational Site
Canal Fulton, Ohio, 44614, United States
GSK Investigational Site
Cincinnati, Ohio, 45211, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Cincinnati, Ohio, 45227, United States
GSK Investigational Site
Cincinnati, Ohio, 45245, United States
GSK Investigational Site
Cleveland, Ohio, 44122, United States
GSK Investigational Site
Columbus, Ohio, 43212, United States
GSK Investigational Site
Columbus, Ohio, 43213, United States
GSK Investigational Site
Dayton, Ohio, 45432, United States
GSK Investigational Site
Dayton, Ohio, 45439, United States
GSK Investigational Site
Kettering, Ohio, 45429, United States
GSK Investigational Site
Mason, Ohio, 45040, United States
GSK Investigational Site
Maumee, Ohio, 43537-9402, United States
GSK Investigational Site
Thornville, Ohio, 43076, United States
GSK Investigational Site
Zanesville, Ohio, 43701, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Tulsa, Oklahoma, 74104, United States
GSK Investigational Site
Tulsa, Oklahoma, 74136, United States
GSK Investigational Site
Ashland, Oregon, 97520, United States
GSK Investigational Site
Bensalem, Pennsylvania, 19020, United States
GSK Investigational Site
Carlisle, Pennsylvania, 17013, United States
GSK Investigational Site
Downington, Pennsylvania, 19335, United States
GSK Investigational Site
Harrisburg, Pennsylvania, 17112, United States
GSK Investigational Site
Landsdale, Pennsylvania, 19446, United States
GSK Investigational Site
Melrose Park, Pennsylvania, 19027, United States
GSK Investigational Site
Tipton, Pennsylvania, 16684, United States
GSK Investigational Site
Uniontown, Pennsylvania, 15401, United States
GSK Investigational Site
Cumberland, Rhode Island, 02864, United States
GSK Investigational Site
East Providence, Rhode Island, 02914, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Greenville, South Carolina, 29601, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Manning, South Carolina, 29102, United States
GSK Investigational Site
Murrells Inlet, South Carolina, 29576, United States
GSK Investigational Site
North Myrtle Beach, South Carolina, 29582, United States
GSK Investigational Site
Orangeburg, South Carolina, 29115, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Taylors, South Carolina, 29687, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Chattanooga, Tennessee, 37421, United States
GSK Investigational Site
Clarksville, Tennessee, 37043, United States
GSK Investigational Site
Columbia, Tennessee, 38401, United States
GSK Investigational Site
Fayetteville, Tennessee, 37334, United States
GSK Investigational Site
Germantown, Tennessee, 38138, United States
GSK Investigational Site
Johnson City, Tennessee, 37604, United States
GSK Investigational Site
McKenzie, Tennessee, 38201, United States
GSK Investigational Site
Memphis, Tennessee, 38125, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Tullahoma, Tennessee, 37398, United States
GSK Investigational Site
Arlington, Texas, 76012, United States
GSK Investigational Site
Bedford, Texas, 76201, United States
GSK Investigational Site
Cleburne, Texas, 76033, United States
GSK Investigational Site
Corpus Christi, Texas, 78404, United States
GSK Investigational Site
Corpus Christi, Texas, 78414, United States
GSK Investigational Site
Dallas, Texas, 75224, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75235, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Dallas, Texas, 75251, United States
GSK Investigational Site
Deer Park, Texas, 77536, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
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Fort Worth, Texas, 76104, United States
GSK Investigational Site
Fort Worth, Texas, 76135, United States
GSK Investigational Site
Houston, Texas, 77024, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77034, United States
GSK Investigational Site
Houston, Texas, 77036, United States
GSK Investigational Site
Houston, Texas, 77055, United States
GSK Investigational Site
Houston, Texas, 77058, United States
GSK Investigational Site
Houston, Texas, 77070, United States
GSK Investigational Site
Houston, Texas, 77074, United States
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Hurst, Texas, 76054, United States
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Katy, Texas, 77450, United States
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Lake Jackson, Texas, 77566, United States
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Lewisville, Texas, 75067, United States
GSK Investigational Site
Midland, Texas, 79707, United States
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North Richland Hills, Texas, 76180, United States
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Odessa, Texas, 79761, United States
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San Antonio, Texas, 78215, United States
GSK Investigational Site
San Antonio, Texas, 78217, United States
GSK Investigational Site
San Antonio, Texas, 78218, United States
GSK Investigational Site
San Antonio, Texas, 78224, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
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Schertz, Texas, 78154, United States
GSK Investigational Site
Sugar Land, Texas, 77479, United States
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Sugarland, Texas, 77479, United States
GSK Investigational Site
Temple, Texas, 76508, United States
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Orem, Utah, 84058, United States
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Salt Lake City, Utah, 84102, United States
GSK Investigational Site
Salt Lake City, Utah, 84107, United States
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West Jordan, Utah, 84088, United States
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West Valley City, Utah, 84120, United States
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South Burlington, Vermont, 05403, United States
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Burke, Virginia, 22015, United States
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Hampton, Virginia, 23666, United States
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Manassas, Virginia, 20110, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23294, United States
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Suffolk, Virginia, United States
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Virgina Beach, Virginia, 23455, United States
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Weber City, Virginia, 24290, United States
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Federal Way, Washington, 98003, United States
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Renton, Washington, 98057, United States
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Richland, Washington, 99352, United States
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Selah, Washington, 98942, United States
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Spokane, Washington, 99208, United States
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Spokane, Washington, 99216, United States
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Tacoma, Washington, 98405, United States
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Lewisburg, West Virginia, 24901, United States
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Milwaukee, Wisconsin, 53226, United States
GSK Investigational Site
Villingen-Schwenningen, Baden-Wurttemberg, 78054, Germany
GSK Investigational Site
Künzing, Bavaria, 94550, Germany
GSK Investigational Site
Kelkheim, Hesse, 65779, Germany
GSK Investigational Site
Rotenburg an der Fulda, Hesse, 36199, Germany
GSK Investigational Site
Bad Lauterberg im Harz, Lower Saxony, 37431, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Berlin, State of Berlin, 10115, Germany
GSK Investigational Site
Chai Wan, Hong Kong
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Kwun Tong, Kowloon, Hong Kong
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Shatin, Hong Kong
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Tai Po, Hong Kong
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Aurangabad, 431001, India
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Bangalore, 560043, India
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Chennai, 600086, India
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Pune, 411 011, India
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Pune, 411011, India
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Ica, Ica, 11, Peru
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Lima, Lima Province, 01, Peru
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Lima, Lima Province, Lima 1, Peru
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Callao, Lima, Callao 2, Peru
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Cebu City, 6000, Philippines
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Marikina City, 1810, Philippines
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Quezon City, 1101, Philippines
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Quezon City, 1102, Philippines
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San Juan City, 1500, Philippines
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Taytay Rizal, 1920, Philippines
GSK Investigational Site
Smolensk, 214 019, Russia
GSK Investigational Site
Yaroslavl, 150062, Russia
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Alzira/Valencia, 46600, Spain
GSK Investigational Site
Barcelona, 08022, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Palma de Mallorca, 07010, Spain
GSK Investigational Site
Seville, 41003, Spain
GSK Investigational Site
Blackpool, Lancashire, FY4 3AD, United Kingdom
GSK Investigational Site
Coventry, West Midlands, CV2 2DX, United Kingdom
GSK Investigational Site
Glasgow, G45 9AW, United Kingdom
GSK Investigational Site
London, SE1 9NH, United Kingdom
Related Publications (3)
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.
PMID: 28683300DERIVEDYoung MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
PMID: 25387217DERIVEDYoung MA, Wald JA, Matthews JE, Yang F, Reinhardt RR. Effect of renal impairment on the pharmacokinetics, efficacy, and safety of albiglutide. Postgrad Med. 2014 May;126(3):35-46. doi: 10.3810/pgm.2014.05.2754.
PMID: 24918790DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2009
First Posted
February 9, 2009
Study Start
February 1, 2009
Primary Completion
January 1, 2012
Study Completion
April 1, 2013
Last Updated
January 9, 2017
Results First Posted
July 1, 2014
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.