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
Showing 1 - 6 of 171 Results
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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Additional information
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