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CompletedPhase 3Results posted

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

Lead sponsor

GlaxoSmithKline

Assets

Albiglutide / Liraglutide

Listed sites

173

Recruiting sites

Enrollment

841

actual

Study population

Type 2 diabetes

Key I/E criterion

HbA1c 7-10%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01128894
Org study ID114179

Timeline

Milestones

Study first posted2010-05-24estimated
Results first posted2014-05-20estimated
Last update posted2017-02-23actual
Study start2010-05 (month precision)
Primary completion2011-09actual (month precision)
Study completion2011-09actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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 </=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.

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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
12
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/registry result

Mean Change From Baseline in Body Weight at Week 32

Time frame:Baseline and Week 32

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kilograms95% CI
Albiglutide 50 mg-0.62
Liraglutide 1.8 mg-2.21
Secondary/protocol endpoint

Mean Change From Baseline in Body Weight at Week 32

Time frame:Baseline and Week 32

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

12 endpoints
Primary/registry result

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32

Time frame:Baseline and Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), Percentage of HbA1c in the blood95% CI
Albiglutide 50 mg-0.78
Liraglutide 1.8 mg-0.99
Mean Difference (Final Values)0.2195% CI0.080.34p0.0846ANCOVA
Primary/protocol endpoint

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32

Time frame:Baseline and Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26

Time frame:Baseline, Weeks 4, 6, 12, 18 and 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percentage of HbA1c in the blood95% CI
Albiglutide 50 mgWeek 4, n=387, 392-0.52
Week 6, n=398, 401-0.66
Week 12, n=398, 402-0.88
Week 18, n=398, 402-0.87
Week 26, n=398, 402-0.79
Liraglutide 1.8 mgWeek 4, n=387, 392-0.73
Week 6, n=398, 401-0.94
Week 12, n=398, 402-1.18
Week 18, n=398, 402-1.13
Week 26, n=398, 402-1.00
Secondary/registry result

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32

Time frame:Baseline and Week 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), Millimoles per liter (mmol/L)95% CI
Albiglutide 50 mg-1.22
Liraglutide 1.8 mg-1.68
Secondary/registry result

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26

Time frame:Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), Millimoles per liter (mmol/L)95% CI
Albiglutide 50 mgWeek 1, n=386, 381-0.98
Week 2, n= 399, 398-1.33
Week 3, n= 400, 402-1.61
Week 4, n= 400, 402-1.52
Week 6, n= 400, 402-1.25
Week 12, n= 400, 402-1.73
Week 18, n= 400, 402-1.44
Week 26, n= 400, 402-1.14
Liraglutide 1.8 mgWeek 1, n=386, 381-1.62
Week 2, n= 399, 398-2.25
Week 3, n= 400, 402-2.43
Week 4, n= 400, 402-2.45
Week 6, n= 400, 402-2.11
Week 12, n= 400, 402-2.10
Week 18, n= 400, 402-1.74
Week 26, n= 400, 402-1.64
Secondary/registry result

Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32

Time frame:Week 32

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), Participants95% CI
Albiglutide 50 mgHbA1c <6.5%78
HbA1c <7.0%168
Liraglutide 1.8 mgHbA1c <6.5%113
HbA1c <7.0%208
Secondary/registry result

Time to Hyperglycemia Rescue at Week 32

Time frame:Week 32

time to event, event

Posted result

GroupValue (median), Weeks95% CI
Albiglutide 50 mgNANA – NA
Liraglutide 1.8 mgNANA – NA
Secondary/protocol endpoint

Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26

Time frame:Baseline, Weeks 4, 6, 12, 18 and 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32

Time frame:Baseline and Week 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26

Time frame:Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32

Time frame:Week 32

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time to Hyperglycemia Rescue at Week 32

Time frame:Week 32

time to event, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.