Safety and Efficacy Study of Albiglutide in Type 2 Diabetes
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
309
3 countries
262
Brief Summary
The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Jan 2009
Longer than P75 for phase_3 diabetes-mellitus-type-2
262 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
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 19, 2009
CompletedFirst Posted
Study publicly available on registry
February 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
June 5, 2014
CompletedJanuary 9, 2017
November 1, 2016
2.8 years
February 19, 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
Glycated hemoglobin (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 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. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. 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.
Baseline and Week 52
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (3)
albiglutide
EXPERIMENTALalbiglutide weekly injection
placebo
PLACEBO COMPARATORalbiglutide matching placebo
albiglutide up-titration
EXPERIMENTALalbiglutide weekly injection uptitration at week 12
Interventions
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 \<6 weeks post-partum
- CHF NYHA class III-IV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (262)
GSK Investigational Site
Alabaster, Alabama, 35007, 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
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, 85051, United States
GSK Investigational Site
Tucson, Arizona, 85745, United States
GSK Investigational Site
Bull Shoals, Arkansas, 72619, United States
GSK Investigational Site
Hot Springs, Arkansas, 71913, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Searcy, Arkansas, 72143, United States
GSK Investigational Site
Carmichael, California, 95608, United States
GSK Investigational Site
Chula Vista, California, 91910, United States
GSK Investigational Site
Foothill Ranch, California, 92610, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Huntington Beach, California, 92646, United States
GSK Investigational Site
Huntington Beach, California, 92648, United States
GSK Investigational Site
Indio, California, 92201, United States
GSK Investigational Site
Irvine, California, 92618, United States
GSK Investigational Site
Lakewood, California, 90712, 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
GSK Investigational Site
Palm Desert, California, 92260, 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
San Diego, California, 92117, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Diego, California, 92128, United States
GSK Investigational Site
San Diego, California, 92177, 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
Torrance, California, 90503, United States
GSK Investigational Site
Victorville, California, 92395, United States
GSK Investigational Site
Vista, California, 92083, 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
New Britain, Connecticut, 06050, United States
GSK Investigational Site
Middletown, Delaware, 19709, United States
GSK Investigational Site
Clearwater, Florida, 33756, 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
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Hallandale, Florida, 33009, United States
GSK Investigational Site
Hialeah, Florida, 33012, United States
GSK Investigational Site
Hollywood, Florida, 33023, United States
GSK Investigational Site
Lauderdale Lakes, Florida, 33319, United States
GSK Investigational Site
Marianna, Florida, 32446, United States
GSK Investigational Site
Miami, Florida, 33156, 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
Saint Cloud, Florida, 34769, 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, 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
Tucker, Georgia, 30084, United States
GSK Investigational Site
Honolulu, Hawaii, 96813, United States
GSK Investigational Site
Honolulu, Hawaii, 96814, United States
GSK Investigational Site
Idaho Falls, Idaho, 83404, United States
GSK Investigational Site
Chicago, Illinois, 60607, United States
GSK Investigational Site
Evergreen Park, Illinois, 60805, 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
Indianapolis, Indiana, 46254, United States
GSK Investigational Site
La Porte, Indiana, 46350, United States
GSK Investigational Site
South Bend, Indiana, 46614, United States
GSK Investigational Site
Council Bluffs, Iowa, 51501, 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
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
Crescent Springs, Kentucky, 41017, 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
Oxon Hill, Maryland, 20745, United States
GSK Investigational Site
Haverhill, Massachusetts, 01830, United States
GSK Investigational Site
Bay City, Michigan, 48708, United States
GSK Investigational Site
Benzonia, Michigan, 49616, United States
GSK Investigational Site
Dearborn, Michigan, 48124, United States
GSK Investigational Site
Interlochen, Michigan, 49643, 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
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, 64111, United States
GSK Investigational Site
Springfield, Missouri, 65807, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
West Plains, Missouri, 65775, 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, 89103, United States
GSK Investigational Site
Las Vegas, Nevada, 89106, United States
GSK Investigational Site
Las Vegas, Nevada, 89128, 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
Stratford, New Jersey, 08084, United States
GSK Investigational Site
North Massapequa, New York, 11758, 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
Chadbourn, North Carolina, 28431, United States
GSK Investigational Site
Fayetteville, North Carolina, 28304, United States
GSK Investigational Site
Greensboro, North Carolina, 27455, United States
GSK Investigational Site
Hickory, North Carolina, 28601, 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
Cleveland, Ohio, 44122, 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
Downington, Pennsylvania, 19335, United States
GSK Investigational Site
Harrisburg, Pennsylvania, 17112, United States
GSK Investigational Site
Lansdale, Pennsylvania, 19446, United States
GSK Investigational Site
Melrose Park, Pennsylvania, 19027, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243, United States
GSK Investigational Site
Tipton, Pennsylvania, 16684, United States
GSK Investigational Site
Uniontown, Pennsylvania, 15401, 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
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
Clarksville, Tennessee, 37043, United States
GSK Investigational Site
Columbia, Tennessee, 38401, United States
GSK Investigational Site
Crossville, Tennessee, 38555, United States
GSK Investigational Site
Johnson City, Tennessee, 37604, United States
GSK Investigational Site
McKenzie, Tennessee, 38201, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Tullahoma, Tennessee, 37388, United States
GSK Investigational Site
Arlington, Texas, 76012, United States
GSK Investigational Site
Cleburne, Texas, 76033, 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, 75251, United States
GSK Investigational Site
Deer Park, Texas, 77536, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
GSK Investigational Site
Fort Worth, Texas, 76104, 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
GSK Investigational Site
Hurst, Texas, 76054, United States
GSK Investigational Site
Katy, Texas, 77450, United States
GSK Investigational Site
Lewisville, Texas, 75067, United States
GSK Investigational Site
Midland, Texas, 79705, United States
GSK Investigational Site
Odessa, Texas, 79761, United States
GSK Investigational Site
San Antonio, Texas, 78215, 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, 78229-4801, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Schertz, Texas, 78154, United States
GSK Investigational Site
Sugar Land, Texas, 77479, United States
GSK Investigational Site
Sugarland, Texas, 77479, United States
GSK Investigational Site
Salt Lake City, Utah, 84102, United States
GSK Investigational Site
Salt Lake City, Utah, 84107, United States
GSK Investigational Site
Salt Lake City, Utah, 84120, United States
GSK Investigational Site
West Jordan, Utah, 84088, United States
GSK Investigational Site
West Valley City, Utah, 84120, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Burke, Virginia, 22015, United States
GSK Investigational Site
Manassas, Virginia, 20110, United States
GSK Investigational Site
Norfolk, Virginia, 23502, United States
GSK Investigational Site
Suffolk, Virginia, 23434, United States
GSK Investigational Site
Virgina Beach, Virginia, 23455, United States
GSK Investigational Site
Weber City, Virginia, 24290, United States
GSK Investigational Site
Richland, Washington, 99352, United States
GSK Investigational Site
Selah, Washington, 98942, United States
GSK Investigational Site
Spokane, Washington, 99216, United States
GSK Investigational Site
Lewisburg, West Virginia, 24901, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, United States
GSK Investigational Site
Tijuana, Baja California Norte, 22010, Mexico
GSK Investigational Site
Pachuca, Hidalgo, 42086, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45200, Mexico
GSK Investigational Site
Morelia, Michoacán, C.P. 58249, Mexico
GSK Investigational Site
Puebla City, Puebla, 72190, Mexico
GSK Investigational Site
Mérida, Yucatán, 97000, Mexico
GSK Investigational Site
Cuernavaca, 62250, Mexico
GSK Investigational Site
Distrito Federal, 06700, Mexico
GSK Investigational Site
Guadalajara, 44600, Mexico
GSK Investigational Site
Guadalajara, 44680, Mexico
GSK Investigational Site
Mexico City, 03300, Mexico
GSK Investigational Site
Mexico City, 11570, Mexico
GSK Investigational Site
Nezahualcóyotl, 57170, Mexico
GSK Investigational Site
Torreón, 27000, Mexico
GSK Investigational Site
Parow, 7505, South Africa
Related Publications (4)
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: 28683300DERIVEDNauck MA, Stewart MW, Perkins C, Jones-Leone A, Yang F, Perry C, Reinhardt RR, Rendell M. Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetologia. 2016 Feb;59(2):266-74. doi: 10.1007/s00125-015-3795-1. Epub 2015 Nov 17.
PMID: 26577795DERIVEDYoung 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)
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 19, 2009
First Posted
February 23, 2009
Study Start
January 1, 2009
Primary Completion
November 1, 2011
Study Completion
February 1, 2013
Last Updated
January 9, 2017
Results First Posted
June 5, 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.