Last updated: 11/07/2018 07:26:34
A study to determine the efficacy and safety of albiglutide as compared with liraglutide.
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 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
Trial description: This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline in glycosylated hemoglobin (HbA1c) at Week 32
Timeframe: Baseline and Week 32
Secondary outcomes:
Mean change from Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26
Timeframe: Baseline, Weeks 4, 6, 12, 18 and 26
Mean change from Baseline in fasting plasma glucose (FPG) at Week 32
Timeframe: Baseline and Week 32
Mean change from Baseline in fasting plasma glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26
Timeframe: 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
Timeframe: Week 32
Time to hyperglycemia rescue at Week 32
Timeframe: Week 32
Mean change from Baseline in body weight at Week 32
Timeframe: Baseline and Week 32
Interventions:
Enrollment:
841
Primary completion date:
2011-09-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Richard Pratley, Michael Nauck, Anthony M Barnett, Mark Feinglos, Ilena Harman-Boehm, Fernando Ovalle, Rhona Scott, June Ye , Susan Johnson, Murray Stewart, and Julio Rosenstock, for the HARMONY 7 Study Group.Once-Weekly Albiglutide, a GLP-1 Receptor Agonist, vs Once-Daily Liraglutide in Patients With Type 2 Diabetes Inadequately Controlled on Oral Agents.Lancet Diabetes Endocrinol.2014;2(4):289-297
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
May 2010 to September 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
- History of cancer
- History of treated diabetic gastroparesis
Inclusion and exclusion criteria
Inclusion criteria:
- 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
- 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.
Exclusion criteria:
- 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
Trial location(s)
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40504
Status
Study Complete
Location
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55430
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Study Complete
Location
GSK Investigational Site
Fremantle, Western Australia, Australia, 6160
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30338
Status
Study Complete
Location
GSK Investigational Site
Morehead City, North Carolina, United States, 28557
Status
Study Complete
Location
GSK Investigational Site
Stone Mountain, Georgia, United States, 30088
Status
Study Complete
Location
GSK Investigational Site
Sugarland, Texas, United States, 77479
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27405
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78215
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76012
Status
Study Complete
Location
GSK Investigational Site
Tullahoma, Tennessee, United States, 37398
Status
Study Complete
Location
GSK Investigational Site
Tampa, Florida, United States, 33613
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Study Complete
Location
GSK Investigational Site
Chula Vista, California, United States, 91910
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33765
Status
Study Complete
Location
GSK Investigational Site
Ringwood East, Victoria, Australia, 3135
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96814
Status
Study Complete
Location
GSK Investigational Site
Gallipolis, Ohio, United States, 45631
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Jordan, Utah, United States, 84088
Status
Study Complete
Location
GSK Investigational Site
La Grange, Illinois, United States, 60525
Status
Study Complete
Location
GSK Investigational Site
Escondido, California, United States, 92026
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68516
Status
Study Complete
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
Tustin, California, United States, 92780
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32822
Status
Study Complete
Location
GSK Investigational Site
Salem, Virginia, United States, 24153
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85032
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89102
Status
Study Complete
Location
GSK Investigational Site
North Massapequa, New York, United States, 11758
Status
Study Complete
Location
GSK Investigational Site
Burlington, North Carolina, United States, 27215
Status
Study Complete
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38125
Status
Study Complete
Location
GSK Investigational Site
Elizabeth, New Jersey, United States, 07202
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33709
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Indiana, United States, 46383
Status
Study Complete
Location
GSK Investigational Site
Palm Desert, California, United States, 92260
Status
Study Complete
Location
GSK Investigational Site
Dearborn, Michigan, United States, 48124
Status
Study Complete
Location
GSK Investigational Site
Murrells Inlet, South Carolina, United States, 29576
Status
Study Complete
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99208
Status
Study Complete
Location
GSK Investigational Site
Clarksville, Tennessee, United States, 37043
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23225
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
St Clair Shores, Michigan, United States, 48081
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71101
Status
Study Complete
Location
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Status
Study Complete
Location
GSK Investigational Site
Irvine, California, United States, 92618
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30312
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78237
Status
Study Complete
Location
GSK Investigational Site
Bloomfield Hills, Michigan, United States, 48302
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Haverhill, Massachusetts, United States, 01830
Status
Study Complete
Location
GSK Investigational Site
Tarzana, California, United States, 91356
Status
Study Complete
Location
GSK Investigational Site
Downington, Pennsylvania, United States, 19335
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33026
Status
Study Complete
Location
GSK Investigational Site
Lenoir, North Carolina, United States, 28645
Status
Study Complete
Location
GSK Investigational Site
Picayune, Mississippi, United States, 39466
Status
Study Complete
Location
GSK Investigational Site
Gilbert, Arizona, United States, 85295
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Staten Island, New York, United States, 10301
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
Satna Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Torrevieja (Alicante), Spain, 03186
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78217
Status
Study Complete
Location
GSK Investigational Site
Paducah, Kentucky, United States, 42003
Status
Study Complete
Location
GSK Investigational Site
Shelby, North Carolina, United States, 28150
Status
Study Complete
Location
GSK Investigational Site
Manassas, Virginia, United States, 20110
Status
Study Complete
Location
GSK Investigational Site
North Richland Hills, Texas, United States, 76180
Status
Study Complete
Location
GSK Investigational Site
Council Bluffs, Iowa, United States, 51501
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90017
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90022
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Searcy, Arkansas, United States, 72143
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30309
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
Status
Study Complete
Location
GSK Investigational Site
Winter Park, Florida, United States, 32792
Status
Terminated/Withdrawn
Location
GSK Investigational Site
London, London, United Kingdom, SE1 9RT
Status
Study Complete
Location
GSK Investigational Site
Indio, California, United States, 92201
Status
Study Complete
Location
GSK Investigational Site
Blue Ridge, Georgia, United States, 30513
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48235
Status
Study Complete
Location
GSK Investigational Site
Canal Fulton, Ohio, United States, 44614
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92648
Status
Study Complete
Location
GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
Location
GSK Investigational Site
Haddon Heights, New Jersey, United States, 08035
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78404
Status
Study Complete
Location
GSK Investigational Site
St Leonards, New South Wales, Australia, 2065
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
West Hills, California, United States, 91307
Status
Study Complete
Location
GSK Investigational Site
Roswell, Georgia, United States, 30076
Status
Study Complete
Location
GSK Investigational Site
Idaho Falls, Idaho, United States, 83404
Status
Study Complete
Location
GSK Investigational Site
North Miami, Florida, United States, 33161
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Spokane, Washington, United States, 99216
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2011-09-09
Actual study completion date
2011-09-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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