DelfaGLP-1 Atlas

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CompletedPhase 3Results posted

A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes

A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

337

Recruiting sites

—

Enrollment

779

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI 20-45

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 IDNCT00838916
Org study ID112754

Timeline

Milestones

Study first posted2009-02-09estimated
Results first posted2014-06-04estimated
Last update posted2017-01-09estimated
Study start2009-02 (month precision)
Primary completion2012-01actual (month precision)
Study completion2013-05actual (month precision)

Assets

Investigational agents

Albiglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

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 within <6 weeks post-partum
•current symptomatic heart failure (NYHA Class III-IV)

Endpoints (11)

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
8
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

GroupValue (least_squares_mean), Kilograms95% CI
Albiglutide 30 mg + Metformin +/- Sulfonylurea-1.05—
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea1.56—
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

GroupValue (mean), Kilograms95% CI
Albiglutide 30 mg + Metformin +/- Sulfonylurea-3.47—
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea0.90—

Glycemic / diabetes

8 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

GroupValue (least_squares_mean), Percentage of HbA1c in the blood95% CI
Albiglutide 30 mg + Metformin +/- Sulfonylurea-0.67—
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea-0.79—
Mean Difference (Net)0.1195% CI-0.04 – 0.27ANCOVA
p0.0086t-test, 1 sided
p0.1463t-test, 2 sided
Secondary/protocol endpoint

Change From Baseline in HbA1c at Week 156

Time frame:Baseline and Week 156

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percentage of HbA1c in the blood95% CI
Albiglutide 30 mg + Metformin +/- Sulfonylurea-0.83—
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea-1.00—
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

GroupValue (least_squares_mean), Millimoles per liter (mmol/L)95% CI
Albiglutide 30 mg + Metformin +/- Sulfonylurea-0.87—
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea-2.06—
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

GroupValue (mean), Millimoles per liter (mmol/L)95% CI
Albiglutide 30 mg + Metformin +/- Sulfonylurea-0.83—
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea-2.19—
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

GroupValue (number), Participants95% CI
Albiglutide 30 mg + Metformin +/- SulfonylureaHbA1c <6.5%54—
HbA1c <7%156—
HbA1c <7.5%268—
Insulin Glargine 10 Units + Metformin +/- SulfonylureaHbA1c <6.5%25—
HbA1c <7%78—
HbA1c <7.5%135—
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

GroupValue (number), Participants95% CI
Albiglutide 30 mg + Metformin +/- SulfonylureaHbA1c <6.5%33—
HbA1c <7%59—
HbA1c <7.5%85—
Insulin Glargine 10 Units + Metformin +/- SulfonylureaHbA1c <6.5%18—
HbA1c <7%46—
HbA1c <7.5%71—
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

GroupValue (median), Weeks95% CI
Albiglutide 30 mg + Metformin +/- Sulfonylurea107.5796.43 – 143.43
Insulin Glargine 10 Units + Metformin +/- SulfonylureaNANA – NA
Secondary/protocol endpoint

Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52

Time frame:Baseline and Week 52

change from baseline, improvement

Posted result

GroupValue (mean), Millimoles per hour per liter (mmol.h/L)95% CI
Albiglutide 30 mg + Metformin +/- Sulfonylurea0.457—
Insulin Glargine 10 Units + Metformin +/- Sulfonylurea-1.657—

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Albiglutide Plasma Concentrations at Week 8 and Week 24

Time frame:Weeks 8 and 24

Plasma concentration (steady state)

concentration, descriptive

Posted result

GroupValue (mean), nanograms/milliliter (ng/mL)95% CI
Albiglutide 30 mg + Metformin +/- SulfonylureaWeek 8, Pre-dose, n=4081642.83—
Week 8, Post-dose, n=3981911.35—
Week 24, Pre-dose, n=4162159.30—
Week 24, Post-dose, n=4012748.15—

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 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.