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CompletedPhase 3Results posted

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

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

262

Recruiting sites

-

Actual enrollment

309

Study population

Type 2 diabetes

Eligibility highlights

•BMI 20-45

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00849017
Org study ID112756

Timeline

Milestones

Study first posted2009-02-23estimated
Results first posted2014-06-05estimated
Last update posted2017-01-09estimated
Study start2009-01 (month precision)
Primary completion2011-11actual (month precision)
Study completion2013-02actual (month precision)

Assets

Investigational agents

Albiglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•type 2 diabetes
•BMI 20-45kg/m2 inclusive

Exclusion criteria

•females who are pregnant, lactating, or <6 weeks post-partum
•CHF NYHA class III-IV

Endpoints (13)

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
10
Weight & body composition
2
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 52

Time frame:Baseline and Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupLeast-squares mean · Kilograms95% CI
Placebo-0.66-
Albiglutide 30 mg-0.39-
Albiglutide 50 mg-0.86-
Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 156

Time frame:Baseline and Week 156

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupMean · Kilograms95% CI
Placebo-2.91-
Albiglutide 30 mg-1.32-
Albiglutide 50 mg-2.24-

Glycemic / diabetes

10 endpoints
Primary/protocol endpoint

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52

Time frame:Baseline and Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupLeast-squares mean · Percentage of HbA1c in the blood95% CI
Placebo0.15-
Albiglutide 30 mg-0.70-
Albiglutide 50 mg-0.89-
Mean difference (net)-0.8495% CI-1.11 - -0.58p<0.0001ANCOVA
Mean difference (net)-1.0495% CI-1.31 - -0.77p<0.0001ANCOVA
Secondary/protocol endpoint

Change From Baseline in HbA1c at Weeks 104 and 156

Time frame:Baseline and Weeks 104 and 156

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupMean · Percentage of HbA1c in the blood95% CI
PlaceboWeek 104, n=21, 39, 42-0.40-
Week 156, n=14, 30, 32-0.61-
Albiglutide 30 mgWeek 104, n=21, 39, 42-0.93-
Week 156, n=14, 30, 32-0.96-
Albiglutide 50 mgWeek 104, n=21, 39, 42-1.18-
Week 156, n=14, 30, 32-1.07-
Secondary/protocol endpoint

Time to Hyperglycemia Rescue

Time frame:From the start of study medication until the end of the treatment (up to Week 156)

time to event, event

Posted result

GroupMedian · Weeks95% CI
Placebo49.7132.14 - 67.29
Albiglutide 30 mg118.4379.43 - NA
Albiglutide 50 mgNANA - NA
Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

Time frame:Baseline and Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupLeast-squares mean · Millimoles per liter (mmol/L)95% CI
Placebo1.00-
Albiglutide 30 mg-0.88-
Albiglutide 50 mg-1.38-
Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156

Time frame:Baseline and Week 156

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupMean · Millimoles per liter (mmol/L)95% CI
Placebo-0.23-
Albiglutide 30 mg-1.31-
Albiglutide 50 mg-1.83-
Secondary/protocol endpoint

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupNumber · Participants95% CI
PlaceboWeek 52, HbA1c <6.5%10-
Week 52, HbA1c <7.0%21-
Week 52, HbA1c <7.5%34-
Albiglutide 30 mgWeek 52, HbA1c <6.5%25-
Week 52, HbA1c <7.0%49-
Week 52, HbA1c <7.5%59-
Albiglutide 50 mgWeek 52, HbA1c <6.5%24-
Week 52, HbA1c <7.0%39-
Week 52, HbA1c <7.5%62-
Secondary/protocol endpoint

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156

Time frame:Week 156

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupNumber · Participants95% CI
PlaceboWeek 156, HbA1c <6.5%6-
Week 156, HbA1c <7.0%8-
Week 156, HbA1c <7.5%13-
Albiglutide 30 mgWeek 156, HbA1c <6.5%10-
Week 156, HbA1c <7.0%18-
Week 156, HbA1c <7.5%24-
Albiglutide 50 mgWeek 156, HbA1c <6.5%11-
Week 156, HbA1c <7.0%19-
Week 156, HbA1c <7.5%29-
Secondary/protocol endpoint

Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC

Time frame:Baseline and Week 52

C-peptide AUC

change from baseline, improvement

Posted result

GroupLeast-squares mean · Nanomoles/Liter (nmol/L)95% CI
Placebo0.05-
Albiglutide 30 mg Weekly0.03-
Albiglutide 50 mg Weekly0.08-
Secondary/protocol endpoint

Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC

Time frame:Baseline and Week 52

Postprandial glucose

change from baseline, improvement

Posted result

GroupLeast-squares mean · Nanomoles/Liter (nmol/L)95% CI
Placebo-0.51-
Albiglutide 30 mg-1.74-
Albiglutide 50 mg-2.05-
Secondary/protocol endpoint/low confidence

Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC

Time frame:Baseline and Week 52

C-peptide AUC

change from baseline, improvement

componentsC-peptide AUC

Posted result

GroupLeast-squares mean · picomoles/Liter (pmol/L)95% CI
Placebo4hr Ins AUC49.2-
4hr Pro-Ins AUC1.0-
Albiglutide 30 mg4hr Ins AUC2.9-
4hr Pro-Ins AUC1.9-
Albiglutide 50 mg4hr Ins AUC39.9-
4hr Pro-Ins AUC-10.7-

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Albiglutide Plasma Concentration at Weeks 8 and 24

Time frame:Weeks 8 and 24

Plasma concentration (steady state)

concentration, descriptive

Posted result

GroupMean · nanograms/milliliter (ng/mL)95% CI
Albiglutide 30 mgWeek 8 Pre-dose, n=85, 851582-
Week 8 Post-dose, n=87, 801900-
Week 24 Pre-dose, n=79, 741912-
Week 24 Post-dose, n=81, 722289-
Albiglutide 50 mgWeek 8 Pre-dose, n=85, 851433-
Week 8 Post-dose, n=87, 801759-
Week 24 Pre-dose, n=79, 743060-
Week 24 Post-dose, n=81, 723484-

Publications (4)

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 6, 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 6, 2026 snapshot.