A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.
A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
841
8 countries
173
Brief Summary
This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide 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 May 2010
173 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
First Submitted
Initial submission to the registry
April 29, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
May 20, 2014
CompletedFebruary 23, 2017
January 1, 2017
1.3 years
April 29, 2010
April 17, 2014
January 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32
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 Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. 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 data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Baseline and Week 32
Secondary Outcomes (6)
Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26
Baseline, Weeks 4, 6, 12, 18 and 26
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32
Baseline and Week 32
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26
Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26
Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32
Week 32
Time to Hyperglycemia Rescue at Week 32
Week 32
- +1 more secondary outcomes
Study Arms (2)
albiglutide
EXPERIMENTALweekly albiglutide subcutaneous injection
liraglutide
ACTIVE COMPARATORliraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
Interventions
liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
Eligibility Criteria
You may qualify if:
- Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
- BMI \>/=20kg/m2 and \</=45 kg/m2
- Fasting C-peptide \>/=0.8 ng/mL (\>/=0.26 nmol/L)
- HbA1c between 7.0% and 10.0%, inclusive
- Female subjects of childbearing potential must be practicing adequate contraception.
You may not qualify if:
- History of cancer
- History of treated diabetic gastroparesis
- Current biliary disease or history of pancreatitis
- History of significant GI surgery
- Recent clinically significant cardiovascular and/or cerebrovascular disease
- Hypertension
- History of human immunodeficiency virus infection
- History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
- History of alcohol or substance abuse
- Female subject is pregnant, lactating, or \<6 weeks postpartum
- Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
- History of type 1 diabetes mellitus
- Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)
- Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
- History or family history of thyroid disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (173)
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Gilbert, Arizona, 85295, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
Searcy, Arkansas, 72143, United States
GSK Investigational Site
Chula Vista, California, 91910, United States
GSK Investigational Site
Escondido, California, 92026, United States
GSK Investigational Site
Fresno, California, 93720, 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
Los Angeles, California, 90017, United States
GSK Investigational Site
Los Angeles, California, 90022, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Palm Desert, California, 92260, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Diego, California, 92128, 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
Walnut Creek, California, 94598, United States
GSK Investigational Site
West Hills, California, 91307, United States
GSK Investigational Site
Clearwater, Florida, 33765, United States
GSK Investigational Site
Cocoa, Florida, 32927, 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
Pembroke Pines, Florida, 33026, United States
GSK Investigational Site
St. Petersburg, Florida, 33709, United States
GSK Investigational Site
Tampa, Florida, 33613, United States
GSK Investigational Site
Winter Park, Florida, 32789, United States
GSK Investigational Site
Winter Park, Florida, 32792, United States
GSK Investigational Site
Atlanta, Georgia, 30309, 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
Roswell, Georgia, 30076, United States
GSK Investigational Site
Stone Mountain, Georgia, 30088, United States
GSK Investigational Site
Honolulu, Hawaii, 96814, United States
GSK Investigational Site
Idaho Falls, Idaho, 83404, United States
GSK Investigational Site
La Grange, Illinois, 60525, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Valparaiso, Indiana, 46383, United States
GSK Investigational Site
Council Bluffs, Iowa, 51501, United States
GSK Investigational Site
Dubuque, Iowa, 52001, United States
GSK Investigational Site
Lexington, Kentucky, 40504, United States
GSK Investigational Site
Paducah, Kentucky, 42003, United States
GSK Investigational Site
Covington, Louisiana, 70433, United States
GSK Investigational Site
Shreveport, Louisiana, 71101, United States
GSK Investigational Site
Haverhill, Massachusetts, 01830, United States
GSK Investigational Site
Bloomfield Hills, Michigan, 48302, United States
GSK Investigational Site
Dearborn, Michigan, 48124, United States
GSK Investigational Site
Detroit, Michigan, 48235, 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
Picayune, Mississippi, 39466, United States
GSK Investigational Site
Kansas City, Missouri, 64111, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Lincoln, Nebraska, 68516, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Las Vegas, Nevada, 89102, United States
GSK Investigational Site
Las Vegas, Nevada, 89103, United States
GSK Investigational Site
Elizabeth, New Jersey, 07202, United States
GSK Investigational Site
Haddon Heights, New Jersey, 08035, United States
GSK Investigational Site
North Massapequa, New York, 11758, United States
GSK Investigational Site
Staten Island, New York, 10301, United States
GSK Investigational Site
Burlington, North Carolina, 27215, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Greensboro, North Carolina, 27405, United States
GSK Investigational Site
Lenoir, North Carolina, 28645, United States
GSK Investigational Site
Morehead City, North Carolina, 28557, United States
GSK Investigational Site
Shelby, North Carolina, 28150, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, 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, 45439, United States
GSK Investigational Site
Gallipolis, Ohio, 45631, United States
GSK Investigational Site
Kettering, Ohio, 45429, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Portland, Oregon, 97239, United States
GSK Investigational Site
Downington, Pennsylvania, 19335, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Murrells Inlet, South Carolina, 29576, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Clarksville, Tennessee, 37043, United States
GSK Investigational Site
Memphis, Tennessee, 38125, United States
GSK Investigational Site
Tullahoma, Tennessee, 37398, United States
GSK Investigational Site
Arlington, Texas, 76012, United States
GSK Investigational Site
Corpus Christi, Texas, 78404, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Dallas, Texas, 75251, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Houston, Texas, 77036, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
Houston, Texas, 77088, United States
GSK Investigational Site
Hurst, Texas, 76054, United States
GSK Investigational Site
Katy, Texas, 77450, United States
GSK Investigational Site
Midland, Texas, 79707, United States
GSK Investigational Site
North Richland Hills, Texas, 76180, United States
GSK Investigational Site
San Antonio, Texas, 78215, United States
GSK Investigational Site
San Antonio, Texas, 78217, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78237, United States
GSK Investigational Site
Schertz, Texas, 78154, United States
GSK Investigational Site
Sugarland, Texas, 77479, United States
GSK Investigational Site
Bountiful, Utah, 84010, United States
GSK Investigational Site
Draper, Utah, 84020, United States
GSK Investigational Site
West Jordan, Utah, 84088, 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
Richmond, Virginia, 23225, United States
GSK Investigational Site
Richmond, Virginia, 23294, United States
GSK Investigational Site
Salem, Virginia, 24153, United States
GSK Investigational Site
Spokane, Washington, 99208, United States
GSK Investigational Site
Spokane, Washington, 99216, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Garran, Australian Capital Territory, 2606, Australia
GSK Investigational Site
Camperdown, New South Wales, 2050, Australia
GSK Investigational Site
St Leonards, New South Wales, 2065, Australia
GSK Investigational Site
Herston, Queensland, 4029, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
Geelong, Victoria, 3220, Australia
GSK Investigational Site
Heidelberg, Victoria, 3081, Australia
GSK Investigational Site
Ringwood East, Victoria, 3135, Australia
GSK Investigational Site
Fremantle, Western Australia, 6160, Australia
GSK Investigational Site
Beersheba, 84101, Israel
GSK Investigational Site
Haifa, 35251, Israel
GSK Investigational Site
Kfar Saba, 44281, Israel
GSK Investigational Site
Nahariya, 22100, Israel
GSK Investigational Site
Ica, Ica, 11, Peru
GSK Investigational Site
Lima, Lima Province, 01, Peru
GSK Investigational Site
Lima, Lima Province, 17, Peru
GSK Investigational Site
Huacho, Lima region, Peru
GSK Investigational Site
Callao, Lima, Callao 2, Peru
GSK Investigational Site
Piura, Piura, Peru
GSK Investigational Site
Lima, Lima 1, Peru
GSK Investigational Site
Cebu City, 6000, Philippines
GSK Investigational Site
Iloilo City, 5000, Philippines
GSK Investigational Site
Makati City, 1218, Philippines
GSK Investigational Site
Marikina City, 1810, Philippines
GSK Investigational Site
Pasay, 1300, Philippines
GSK Investigational Site
Pasig, 1600, Philippines
GSK Investigational Site
Goyang, 414410, South Korea
GSK Investigational Site
Seongnam-si, 463-707, South Korea
GSK Investigational Site
Seongnam-si, 463712, South Korea
GSK Investigational Site
Seoul, 135720, South Korea
GSK Investigational Site
Seoul, 136-705, South Korea
GSK Investigational Site
Seoul, 137-701, South Korea
GSK Investigational Site
Seoul, 139-872, South Korea
GSK Investigational Site
A Coruña, 15006, Spain
GSK Investigational Site
Alicante, 03114, Spain
GSK Investigational Site
Majadahonda (Madrid), 28222, Spain
GSK Investigational Site
Modulo H, 07120, Spain
GSK Investigational Site
Sabadell, 08208, Spain
GSK Investigational Site
Torrevieja (Alicante), 03186, Spain
GSK Investigational Site
London, London, SE1 9RT, United Kingdom
GSK Investigational Site
Birmingham, B9 5SS, United Kingdom
GSK Investigational Site
Hertfordshire, United Kingdom
GSK Investigational Site
Livingston, EH54 6PP, United Kingdom
GSK Investigational Site
Swansea, SA6 6NL, United Kingdom
Related Publications (1)
Pratley RE, Nauck MA, Barnett AH, Feinglos MN, Ovalle F, Harman-Boehm I, Ye J, Scott R, Johnson S, Stewart M, Rosenstock J; HARMONY 7 study group. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol. 2014 Apr;2(4):289-297. doi: 10.1016/S2213-8587(13)70214-6. Epub 2014 Feb 6.
PMID: 24703047DERIVED
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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2010
First Posted
May 24, 2010
Study Start
May 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
February 23, 2017
Results First Posted
May 20, 2014
Record last verified: 2017-01
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.