NCT00849056

Brief Summary

The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
6 countries

331 active sites

Status
completed

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

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 1, 2014

Completed
Last Updated

January 9, 2017

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

February 19, 2009

Results QC Date

April 24, 2014

Last Update Submit

November 18, 2016

Conditions

Keywords

diabetes

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 + current antidiabetic therapy. 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. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.

    Baseline and Week 52

Secondary Outcomes (8)

  • Change From Baseline in HbA1c at Weeks 104 and 156

    Baseline and Weeks 104 and 156

  • Time to Hyperglycemia Rescue

    From the start of study medication until the end of the treatment (up to Week 156)

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

    Baseline and Week 52

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156

    Baseline and 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 (2)

placebo + pioglitazone (with or without metformin)

PLACEBO COMPARATOR

Placebo albiglutide weekly injection + pioglitazone (with or without metformin)

Drug: placebo

albiglutide + pioglitazone (with or without metformin)

EXPERIMENTAL

albiglutide weekly injection + pioglitazone (with or without meformin)

Biological: albiglutide

Interventions

albiglutideBIOLOGICAL

albiglutide weekly subcutaneous injection

albiglutide + pioglitazone (with or without metformin)

placebo weekly subcutaneous injection

placebo + pioglitazone (with or without metformin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • BMI 20-45kg/m2

You may not qualify if:

  • NYHA Class II to IV heart failure
  • females who are pregnant, lactating, or less than 6 weeks post-partum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (331)

GSK Investigational Site

Alabaster, Alabama, 35007, United States

Location

GSK Investigational Site

Birmingham, Alabama, 35205, United States

Location

GSK Investigational Site

Birmingham, Alabama, 35235, United States

Location

GSK Investigational Site

Birmingham, Alabama, 35242, United States

Location

GSK Investigational Site

Dothan, Alabama, 36301, United States

Location

GSK Investigational Site

Hueytown, Alabama, 35023, United States

Location

GSK Investigational Site

Mobile, Alabama, 36617, United States

Location

GSK Investigational Site

Tuscaloosa, Alabama, 35406, United States

Location

GSK Investigational Site

Chandler, Arizona, 85224, United States

Location

GSK Investigational Site

Gilbert, Arizona, 85295, United States

Location

GSK Investigational Site

Green Valley, Arizona, 85614, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85023, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85028, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85032, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85051, United States

Location

GSK Investigational Site

Tucson, Arizona, 85745, United States

Location

GSK Investigational Site

Bull Shoals, Arkansas, 72619, United States

Location

GSK Investigational Site

Harrisburg, Arkansas, 72432, United States

Location

GSK Investigational Site

Hot Springs, Arkansas, 71913, United States

Location

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Searcy, Arkansas, 72143, United States

Location

GSK Investigational Site

Buena Park, California, 90620, United States

Location

GSK Investigational Site

Carmichael, California, 95608, United States

Location

GSK Investigational Site

Chula Vista, California, 91910, United States

Location

GSK Investigational Site

Foothill Ranch, California, 92610, United States

Location

GSK Investigational Site

Fountain Valley, California, 92708, United States

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GSK Investigational Site

Fresno, California, 93720, United States

Location

GSK Investigational Site

Fullerton, California, 92835, United States

Location

GSK Investigational Site

Huntington Beach, California, 92646, United States

Location

GSK Investigational Site

Huntington Beach, California, 92648, United States

Location

GSK Investigational Site

Indio, California, 92201, United States

Location

GSK Investigational Site

Irvine, California, 92618, United States

Location

GSK Investigational Site

La Jolla, California, 92037, United States

Location

GSK Investigational Site

Lakewood, California, 90712, United States

Location

GSK Investigational Site

Long Beach, California, 90806, United States

Location

GSK Investigational Site

Los Alamitos, California, 90720, United States

Location

GSK Investigational Site

Los Angeles, California, 90017, United States

Location

GSK Investigational Site

Los Angeles, California, 90022, United States

Location

GSK Investigational Site

Los Angeles, California, 90025, United States

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GSK Investigational Site

Mission Viejo, California, 92691, United States

Location

GSK Investigational Site

Northridge, California, 91325, United States

Location

GSK Investigational Site

Palm Desert, California, 92260, United States

Location

GSK Investigational Site

Palm Springs, California, 92262, United States

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GSK Investigational Site

Pasadena, California, 91105, United States

Location

GSK Investigational Site

Poway, California, 92064, United States

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GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

Sacramento, California, 95821, United States

Location

GSK Investigational Site

Sacramento, California, 95825, United States

Location

GSK Investigational Site

San Diego, California, 92117, United States

Location

GSK Investigational Site

San Diego, California, 92120, United States

Location

GSK Investigational Site

Satna Monica, California, 90404, United States

Location

GSK Investigational Site

Tarzana, California, 91356, United States

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GSK Investigational Site

Torrance, California, 90503, United States

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GSK Investigational Site

Tustin, California, 92780, United States

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GSK Investigational Site

Victorville, California, 92395, United States

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GSK Investigational Site

Walnut Creek, California, 94598, United States

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GSK Investigational Site

West Hills, California, 91307, United States

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GSK Investigational Site

Arvada, Colorado, 80005, United States

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GSK Investigational Site

Denver, Colorado, 80209, United States

Location

GSK Investigational Site

New Britain, Connecticut, 06050, United States

Location

GSK Investigational Site

Trumbull, Connecticut, 06611, United States

Location

GSK Investigational Site

Waterbury, Connecticut, 06708, United States

Location

GSK Investigational Site

Middletown, Delaware, 19709, United States

Location

GSK Investigational Site

Clearwater, Florida, 33756, United States

Location

GSK Investigational Site

Clearwater, Florida, 33765, United States

Location

GSK Investigational Site

Cocoa, Florida, 32927, United States

Location

GSK Investigational Site

Cutler Bay, Florida, 33189, United States

Location

GSK Investigational Site

Deerfield Beach, Florida, 33442, United States

Location

GSK Investigational Site

Delray Beach, Florida, 33445, United States

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GSK Investigational Site

Edgewater, Florida, 32132, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

Location

GSK Investigational Site

Gainesville, Florida, 32605, United States

Location

GSK Investigational Site

Hallandale, Florida, 33009, United States

Location

GSK Investigational Site

Hialeah, Florida, 33012, United States

Location

GSK Investigational Site

Hialeah, Florida, 33013, United States

Location

GSK Investigational Site

Hollywood, Florida, 33023, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32205, United States

Location

GSK Investigational Site

Lauderdale Lakes, Florida, 33319, United States

Location

GSK Investigational Site

Marianna, Florida, 32446, United States

Location

GSK Investigational Site

Miami, Florida, 33135, United States

Location

GSK Investigational Site

Miami, Florida, 33156, United States

Location

GSK Investigational Site

North Miami, Florida, 33161, United States

Location

GSK Investigational Site

Ocala, Florida, 34471, United States

Location

GSK Investigational Site

Orlando, Florida, 32822, United States

Location

GSK Investigational Site

Ormond Beach, Florida, 32174, United States

Location

GSK Investigational Site

Oviedo, Florida, 32765, United States

Location

GSK Investigational Site

Panama City, Florida, 32401, United States

Location

GSK Investigational Site

Pembroke Pines, Florida, 33026, United States

Location

GSK Investigational Site

Pembroke Pines, Florida, 33027, United States

Location

GSK Investigational Site

Plantation, Florida, 33317, United States

Location

GSK Investigational Site

Ponte Verda, Florida, 32081, United States

Location

GSK Investigational Site

Saint Cloud, Florida, 34769, United States

Location

GSK Investigational Site

Tampa, Florida, 33603, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30308, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30309, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30312, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30328, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30338, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Blue Ridge, Georgia, 30513, United States

Location

GSK Investigational Site

Columbus, Georgia, 31904, United States

Location

GSK Investigational Site

Decatur, Georgia, 30032, United States

Location

GSK Investigational Site

Savannah, Georgia, 31406, United States

Location

GSK Investigational Site

Savannah, Georgia, 31419, United States

Location

GSK Investigational Site

Snellville, Georgia, 30078, United States

Location

GSK Investigational Site

Stone Mountain, Georgia, 30088, United States

Location

GSK Investigational Site

Tucker, Georgia, 30084, United States

Location

GSK Investigational Site

Honolulu, Hawaii, 96813, United States

Location

GSK Investigational Site

Honolulu, Hawaii, 96814, United States

Location

GSK Investigational Site

Boise, Idaho, 83702, United States

Location

GSK Investigational Site

Idaho Falls, Idaho, 83404, United States

Location

GSK Investigational Site

Chicago, Illinois, 60607, United States

Location

GSK Investigational Site

Evergreen Park, Illinois, 60805, United States

Location

GSK Investigational Site

La Grange, Illinois, 60525, United States

Location

GSK Investigational Site

Naperville, Illinois, 60564, United States

Location

GSK Investigational Site

Peoria, Illinois, 61602, United States

Location

GSK Investigational Site

Avon, Indiana, 46123, United States

Location

GSK Investigational Site

Evansville, Indiana, 47714, United States

Location

GSK Investigational Site

Fishers, Indiana, 46037, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46254, United States

Location

GSK Investigational Site

La Porte, Indiana, 46350, United States

Location

GSK Investigational Site

Lafayette, Indiana, 47904, United States

Location

GSK Investigational Site

South Bend, Indiana, 46614, United States

Location

GSK Investigational Site

Council Bluffs, Iowa, 51501, United States

Location

GSK Investigational Site

Des Moines, Iowa, 50314, United States

Location

GSK Investigational Site

Dubuque, Iowa, 52001, United States

Location

GSK Investigational Site

Iowa City, Iowa, 52243, United States

Location

GSK Investigational Site

Waterloo, Iowa, 50701, United States

Location

GSK Investigational Site

Arkansas City, Kansas, 67005, United States

Location

GSK Investigational Site

Mission, Kansas, 66202, United States

Location

GSK Investigational Site

Newton, Kansas, 67114, United States

Location

GSK Investigational Site

Overland Park, Kansas, 66211, United States

Location

GSK Investigational Site

Topeka, Kansas, 66606, United States

Location

GSK Investigational Site

Crescent Springs, Kentucky, 41017, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40504, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40202, United States

Location

GSK Investigational Site

Paducah, Kentucky, 42003, United States

Location

GSK Investigational Site

Covington, Louisiana, 70433, United States

Location

GSK Investigational Site

Lake Charles, Louisiana, 70601, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71101, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71115, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21237, United States

Location

GSK Investigational Site

Hyattsville, Maryland, 20782, United States

Location

GSK Investigational Site

Oxon Hill, Maryland, 20745, United States

Location

GSK Investigational Site

Haverhill, Massachusetts, 01830, United States

Location

GSK Investigational Site

Bay City, Michigan, 48708, United States

Location

GSK Investigational Site

Benzonia, Michigan, 49616, United States

Location

GSK Investigational Site

Bloomfield Hills, Michigan, 48302, United States

Location

GSK Investigational Site

Dearborn, Michigan, 48124, United States

Location

GSK Investigational Site

Interlochen, Michigan, 49643, United States

Location

GSK Investigational Site

Kalamazoo, Michigan, 49009, United States

Location

GSK Investigational Site

Kalamazoo, Michigan, 49048, United States

Location

GSK Investigational Site

Saint Clair Shores, Michigan, 48081, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55430, United States

Location

GSK Investigational Site

Gulfport, Mississippi, 39501, United States

Location

GSK Investigational Site

Picayune, Mississippi, 39466, United States

Location

GSK Investigational Site

Rolling Fork, Mississippi, 39159, United States

Location

GSK Investigational Site

Chesterfield, Missouri, 63017, United States

Location

GSK Investigational Site

Jefferson City, Missouri, 65109, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64106, United States

Location

GSK Investigational Site

Kansas City, Missouri, United States

Location

GSK Investigational Site

St Louis, Missouri, 63117, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

West Plains, Missouri, 65775, United States

Location

GSK Investigational Site

Billings, Montana, 59102, United States

Location

GSK Investigational Site

Butte, Montana, 59701, United States

Location

GSK Investigational Site

Great Falls, Montana, 59404, United States

Location

GSK Investigational Site

Broken Bow, Nebraska, 68822, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68516, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68124, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68131, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68134, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89102, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89103, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89106, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89128, United States

Location

GSK Investigational Site

Berlin, New Jersey, 08009, United States

Location

GSK Investigational Site

Elizabeth, New Jersey, 07202, United States

Location

GSK Investigational Site

Haddon Heights, New Jersey, 08035, United States

Location

GSK Investigational Site

Hainesport, New Jersey, 08036, United States

Location

GSK Investigational Site

Stratford, New Jersey, 08084, United States

Location

GSK Investigational Site

New York, New York, 10022, United States

Location

GSK Investigational Site

North Massapequa, New York, 11758, United States

Location

GSK Investigational Site

Asheboro, North Carolina, 27203, United States

Location

GSK Investigational Site

Asheville, North Carolina, 28803, United States

Location

GSK Investigational Site

Burlington, North Carolina, 27215, United States

Location

GSK Investigational Site

Calabash, North Carolina, 28467, United States

Location

GSK Investigational Site

Chadbourn, North Carolina, 28431, United States

Location

GSK Investigational Site

Durham, North Carolina, 27710, United States

Location

GSK Investigational Site

Fayetteville, North Carolina, 28304, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27405, United States

Location

GSK Investigational Site

Hickory, North Carolina, 28601, United States

Location

GSK Investigational Site

Lenoir, North Carolina, 28645, United States

Location

GSK Investigational Site

Mint Hill, North Carolina, 28227, United States

Location

GSK Investigational Site

Morehead City, North Carolina, 28557, United States

Location

GSK Investigational Site

Shelby, North Carolina, 28150, United States

Location

GSK Investigational Site

Tabor City, North Carolina, 28463, United States

Location

GSK Investigational Site

Akron, Ohio, 44320, United States

Location

GSK Investigational Site

Canal Fulton, Ohio, 44614, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45227, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45245, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44122, United States

Location

GSK Investigational Site

Columbus, Ohio, 43213, United States

Location

GSK Investigational Site

Dayton, Ohio, 45432, United States

Location

GSK Investigational Site

Dayton, Ohio, 45439, United States

Location

GSK Investigational Site

Kettering, Ohio, 45429, United States

Location

GSK Investigational Site

Mason, Ohio, 45040, United States

Location

GSK Investigational Site

Maumee, Ohio, 43537-9402, United States

Location

GSK Investigational Site

Thornville, Ohio, 43076, United States

Location

GSK Investigational Site

Zanesville, Ohio, 43701, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73116, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74104, United States

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GSK Investigational Site

Tulsa, Oklahoma, 74136, United States

Location

GSK Investigational Site

Ashland, Oregon, 97520, United States

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GSK Investigational Site

Bensalem, Pennsylvania, 19020, United States

Location

GSK Investigational Site

Carlisle, Pennsylvania, 17013, United States

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GSK Investigational Site

Downington, Pennsylvania, 19335, United States

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GSK Investigational Site

Feasterville, Pennsylvania, 19053, United States

Location

GSK Investigational Site

Harrisburg, Pennsylvania, 17112, United States

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GSK Investigational Site

Landsdale, Pennsylvania, 19446, United States

Location

GSK Investigational Site

Melrose Park, Pennsylvania, 19027, United States

Location

GSK Investigational Site

Tipton, Pennsylvania, 16684, United States

Location

GSK Investigational Site

Uniontown, Pennsylvania, 15401, United States

Location

GSK Investigational Site

Cumberland, Rhode Island, 02864, United States

Location

GSK Investigational Site

East Providence, Rhode Island, 02914, United States

Location

GSK Investigational Site

Columbia, South Carolina, 29201, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29601, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29605, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Greer, South Carolina, 29651, United States

Location

GSK Investigational Site

Murrells Inlet, South Carolina, 29576, United States

Location

GSK Investigational Site

North Myrtle Beach, South Carolina, 29582, United States

Location

GSK Investigational Site

Orangeburg, South Carolina, 29115, United States

Location

GSK Investigational Site

Simpsonville, South Carolina, 29681, United States

Location

GSK Investigational Site

Bristol, Tennessee, 37620, United States

Location

GSK Investigational Site

Chattanooga, Tennessee, 37421, United States

Location

GSK Investigational Site

Clarksville, Tennessee, 37043, United States

Location

GSK Investigational Site

Columbia, Tennessee, 38401, United States

Location

GSK Investigational Site

Crossville, Tennessee, 38555, United States

Location

GSK Investigational Site

Fayetteville, Tennessee, 37334, United States

Location

GSK Investigational Site

Germantown, Tennessee, 38138, United States

Location

GSK Investigational Site

Johnson City, Tennessee, 37604, United States

Location

GSK Investigational Site

McKenzie, Tennessee, 38201, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38125, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Tullahoma, Tennessee, 37398, United States

Location

GSK Investigational Site

Arlington, Texas, 76012, United States

Location

GSK Investigational Site

Bedford, Texas, 76201, United States

Location

GSK Investigational Site

Cleburne, Texas, 76033, United States

Location

GSK Investigational Site

Corpus Christi, Texas, 78404, United States

Location

GSK Investigational Site

Corpus Christi, Texas, 78414, United States

Location

GSK Investigational Site

Dallas, Texas, 75224, United States

Location

GSK Investigational Site

Dallas, Texas, 75230, United States

Location

GSK Investigational Site

Dallas, Texas, 75235, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Dallas, Texas, 75251, United States

Location

GSK Investigational Site

Deer Park, Texas, 77536, United States

Location

GSK Investigational Site

El Paso, Texas, 79925, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76135, United States

Location

GSK Investigational Site

Houston, Texas, 77024, United States

Location

GSK Investigational Site

Houston, Texas, 77027, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Houston, Texas, 77034, United States

Location

GSK Investigational Site

Houston, Texas, 77036, United States

Location

GSK Investigational Site

Houston, Texas, 77055, United States

Location

GSK Investigational Site

Houston, Texas, 77058, United States

Location

GSK Investigational Site

Houston, Texas, 77070, United States

Location

GSK Investigational Site

Houston, Texas, 77074, United States

Location

GSK Investigational Site

Hurst, Texas, 76054, United States

Location

GSK Investigational Site

Katy, Texas, 77450, United States

Location

GSK Investigational Site

Lake Jackson, Texas, 77566, United States

Location

GSK Investigational Site

Lewisville, Texas, 75067, United States

Location

GSK Investigational Site

Midland, Texas, 79707, United States

Location

GSK Investigational Site

North Richland Hills, Texas, 76180, United States

Location

GSK Investigational Site

Odessa, Texas, 79761, United States

Location

GSK Investigational Site

San Antonio, Texas, 78205, United States

Location

GSK Investigational Site

San Antonio, Texas, 78215, United States

Location

GSK Investigational Site

San Antonio, Texas, 78218, United States

Location

GSK Investigational Site

San Antonio, Texas, 78224, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

San Antonio, Texas, 78258, United States

Location

GSK Investigational Site

Schertz, Texas, 78154, United States

Location

GSK Investigational Site

Sugar Land, Texas, 77479, United States

Location

GSK Investigational Site

Sugarland, Texas, 77479, United States

Location

GSK Investigational Site

Bountiful, Utah, 84010, United States

Location

GSK Investigational Site

Orem, Utah, 84058, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84107, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84120, United States

Location

GSK Investigational Site

West Jordan, Utah, 84088, United States

Location

GSK Investigational Site

West Valley City, Utah, 84120, United States

Location

GSK Investigational Site

South Burlington, Vermont, 05403, United States

Location

GSK Investigational Site

Burke, Virginia, 22015, United States

Location

GSK Investigational Site

Hampton, Virginia, 23666, United States

Location

GSK Investigational Site

Manassas, Virginia, 20110, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23502, United States

Location

GSK Investigational Site

Richmond, Virginia, 23294, United States

Location

GSK Investigational Site

Suffolk, Virginia, United States

Location

GSK Investigational Site

Weber City, Virginia, 24290, United States

Location

GSK Investigational Site

Federal Way, Washington, 98003, United States

Location

GSK Investigational Site

Renton, Washington, 98057, United States

Location

GSK Investigational Site

Richland, Washington, 99352, United States

Location

GSK Investigational Site

Selah, Washington, 98942, United States

Location

GSK Investigational Site

Spokane, Washington, 99208, United States

Location

GSK Investigational Site

Spokane, Washington, 99216, United States

Location

GSK Investigational Site

Tacoma, Washington, 98405, United States

Location

GSK Investigational Site

Lewisburg, West Virginia, 24901, United States

Location

GSK Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

GSK Investigational Site

Aurangabad, 431001, India

Location

GSK Investigational Site

Pune, 411011, India

Location

GSK Investigational Site

Arequipa, Arequipa, 54, Peru

Location

GSK Investigational Site

Lima, Lima Province, 17, Peru

Location

GSK Investigational Site

El Agustino, Lima region, 10, Peru

Location

GSK Investigational Site

Huacho, Lima region, Peru

Location

GSK Investigational Site

Trujillo, Peru

Location

GSK Investigational Site

Port Elizabeth, Eastern Cape, 6014, South Africa

Location

GSK Investigational Site

Phoenix, KwaZulu-Natal, 4068, South Africa

Location

GSK Investigational Site

Kempton Park, 1619, South Africa

Location

GSK Investigational Site

Somerset West, 07129, South Africa

Location

GSK Investigational Site

Seongnam-si, 463712, South Korea

Location

GSK Investigational Site

Suwon, Kyonggi-do, 443-721, South Korea

Location

GSK Investigational Site

Canterbury, Kent, CT1 3HX, United Kingdom

Location

GSK Investigational Site

Blackpool, Lancashire, FY4 3AD, United Kingdom

Location

GSK Investigational Site

Sunbury-on-Thames, Middlesex, TW16 6RH, United Kingdom

Location

GSK Investigational Site

Port Glasgow, Renfrewshire, PA14 6HW, United Kingdom

Location

GSK Investigational Site

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

GSK Investigational Site

Glasgow, G45 9AW, United Kingdom

Location

GSK Investigational Site

Liverpool, L9 7AL, United Kingdom

Location

GSK Investigational Site

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

rGLP-1 protein

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

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 19, 2009

First Posted

February 23, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2011

Study Completion

January 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.

Available IPD Datasets

Individual Participant Data Set (112755)Access
Study Protocol (112755)Access
Dataset Specification (112755)Access
Clinical Study Report (112755)Access
Statistical Analysis Plan (112755)Access
Informed Consent Form (112755)Access
Annotated Case Report Form (112755)Access

Locations