GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus

A 52-Week, Open-Label, Multicenter Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

374

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 17-40•HbA1c 7-10%

Primary endpoints

•Any Adverse Event (AE) or Any Serious Adverse Event (SAE) (Treatment-emergent AEs (any), Serious AEs (any))•Documented hypoglycemia

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 IDNCT01777282

Org study ID116170

Timeline

Milestones

Study first posted2013-01-28estimated

Study start2013-02-23actual

Primary completion2015-01-27actual

Study completion2015-01-27actual

Results first posted2015-10-14estimated

Last update posted2017-05-03actual

Assets

Investigational agents

Albiglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects with diagnosis of Type 2 Diabetes Mellitus, who are experiencing inadequate glycemic control and receiving treatment with a stable dose of a single oral antidiabetic medication

•Body mass index (BMI) 17 to 40 kg/ m2 inclusive

•Subjects with an HbA1c between 7.0% and 10.0% at Screening

•Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)

Exclusion criteria

•History of type 1 diabetes mellitus

•Female subject is pregnant, lactating, or <6 weeks postpartum

•Clinically significant cardiovascular and/or cerebrovascular disease

•Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator

•Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis

•Prior use of a GLP-1R agonist or DPP-IV inhibitor within 6 months before Screening

Endpoints (7)

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

Safety / tolerability / PK

Weight & body composition

1 endpoint

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

Group	Value (mean), Kilograms (kg)	95% CI
Albiglutide Plus (+) Background OAD (Sulfonylurea)	0.25	—
Albiglutide Plus (+) Background OAD (Biguanide)	-0.33	—
Albiglutide Plus (+) Background OAD (Glinide)	-0.04	—
Albiglutide Plus (+) Background OAD (Thiazolidinedione)	0.52	—
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)	-0.13	—

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline and Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c in the blood	95% CI
Albiglutide Plus (+) Background OAD (Sulfonylurea)	-1.04	—
Albiglutide Plus (+) Background OAD (Biguanide)	-0.94	—
Albiglutide Plus (+) Background OAD (Glinide)	-0.95	—
Albiglutide Plus (+) Background OAD (Thiazolidinedione)	-1.42	—
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)	-1.39	—

Secondary/protocol endpoint

Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Albiglutide Plus (+) Background OAD (Sulfonylurea)HbA1c <6.5%	20.0	—
HbA1c <7.0%	54.2	—
Albiglutide Plus (+) Background OAD (Biguanide)HbA1c <6.5%	26.9	—
HbA1c <7.0%	59.7	—
Albiglutide Plus (+) Background OAD (Glinide)HbA1c <6.5%	24.6	—
HbA1c <7.0%	52.3	—
Albiglutide Plus (+) Background OAD (Thiazolidinedione)HbA1c <6.5%	45.9	—
HbA1c <7.0%	80.3	—
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)HbA1c <6.5%	26.2	—
HbA1c <7.0%	67.2	—

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

Group	Value (mean), Milligrams per deciliter (mg/dL)	95% CI
Albiglutide Plus (+) Background OAD (Sulfonylurea)	-16.4	—
Albiglutide Plus (+) Background OAD (Biguanide)	-24.3	—
Albiglutide Plus (+) Background OAD (Glinide)	-16.4	—
Albiglutide Plus (+) Background OAD (Thiazolidinedione)	-32.1	—
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)	-33.2	—

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)

Time frame:From Baseline through Week 52

threshold achievement, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Posted result

Group	Value (number), Participants	95% CI
Albiglutide Plus (+) Background OAD (Sulfonylurea)Any AE	97	—
Any SAE	2	—
Albiglutide Plus (+) Background OAD (Biguanide)Any AE	47	—
Any SAE	0	—
Albiglutide Plus (+) Background OAD (Glinide)Any AE	58	—
Any SAE	1	—
Albiglutide Plus (+) Background OAD (Thiazolidinedione)Any AE	49	—
Any SAE	2	—
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)Any AE	43	—
Any SAE	3	—

Primary/protocol endpoint

Number of Participants With Any Hypoglycemic Event

Time frame:From Baseline through Week 52

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Participants	95% CI
Albiglutide Plus (+) Background OAD (Sulfonylurea)	17	—
Albiglutide Plus (+) Background OAD (Biguanide)	1	—
Albiglutide Plus (+) Background OAD (Glinide)	4	—
Albiglutide Plus (+) Background OAD (Thiazolidinedione)	2	—
Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)	0	—

Secondary/protocol endpoint

Time to Study Withdrawal Due to Hyperglycemia

Time frame:Week 52

Discontinuation due to AE

time to event, event

Posted result

Group	Value (mean), Weeks	95% CI
Albiglutide Plus (+) Background OAD (Sulfonylurea)	13.0	—
Albiglutide Plus (+) Background OAD (Glinide)	16.5	—

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

Albiglutide, a weekly GLP-1 receptor agonist, improves glycemic parameters in Japanese patients with type 2 diabetes over 1 year when added to single oral antidiabetic drugs.
Current medical research and opinion2017 Mar (month)PMID27852119doi:10.1080/03007995.2016.1261817via clinicaltrials gov reference derived + pubmed nct search

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.