GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

GlaxoSmithKline

Assets

Albiglutide / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

494

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 17-40•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 IDNCT01733758

Org study ID113121

Timeline

Milestones

Study first posted2012-11-27estimated

Results first posted2015-05-18estimated

Last update posted2016-09-22estimated

Study start2013-02 (month precision)

Primary completion2014-06actual (month precision)

Study completion2015-02actual (month precision)

Assets

Investigational agents

Albiglutide Liraglutide

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, treated with diet and exercise or a stable dose of 1 OAD at screening

•Body mass index (BMI) 17 to 40 kg/ m^2 inclusive

•Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening and HbA1c between 7.0% and 10.0% at Visit 2

•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 TZD or GLP-1R agonist within 4 months before Screening

Endpoints (22)

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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline in Body Weight at Week 24

Time frame:Baseline and Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilograms (kg)	95% CI
PlaceboBaseline	68.65	—
Week 24	68.15	—
Change from Baseline at Week 24	-0.50	—
Albiglutide 30 mg WeeklyBaseline	69.46	—
Week 24	69.78	—
Change from Baseline at Week 24	0.32	—
Albiglutide 50 mg WeeklyBaseline	71.54	—
Week 24	71.50	—
Change from Baseline at Week 24	-0.04	—
Open-Label Liraglutide 0.9 mg DailyBaseline	72.65	—
Week 24	72.30	—
Change from Baseline at Week 24	-0.34	—

Secondary/registry result

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
PlaceboBaseline	68.07	—
Week 52	68.00	—
Change from Baseline at Week 52	-0.07	—
Albiglutide 30 mg WeeklyBaseline	70.07	—
Week 52	70.15	—
Change from Baseline at Week 52	0.08	—
Albiglutide 50 mg WeeklyBaseline	71.27	—
Week 52	70.96	—
Change from Baseline at Week 52	-0.31	—
Open-Label Liraglutide 0.9 mg DailyBaseline	72.43	—
Week 52	71.93	—
Change from Baseline at Week 52	-0.50	—

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 24

Time frame:Baseline and Week 24

Body weight, absolute change (kg)

change from baseline, improvement

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

Glycemic / diabetes

14 endpoints

Primary/registry result

Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Time frame:Baseline and Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c in the blood	95% CI
Placebo	0.25	—
Albiglutide 30 mg Weekly	-1.10	—
Albiglutide 50 mg Weekly	-1.30	—

Mean Difference (Net)-1.5595% CI-1.72 – -1.39ANCOVA

Mean Difference (Net)-1.3595% CI-1.51 – -1.18ANCOVA

p<0.0001t-test, 2 sided

Primary/registry result

Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24

Time frame:Baseline and Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c in the blood	95% CI
PlaceboBaseline	8.16	—
Week 24	8.39	—
Change from Baseline	0.24	—
Albiglutide 30 mg WeeklyBaseline	8.06	—
Week 24	6.98	—
Change from Baseline	-1.08	—
Albiglutide 50 mg WeeklyBaseline	8.15	—
Week 24	6.83	—
Change from Baseline	-1.32	—
Open-Label Liraglutide 0.9 mg DailyBaseline	8.07	—
Week 24	6.87	—
Change from Baseline	-1.19	—

Primary/protocol endpoint

Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Time frame:Baseline and Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24

Time frame:Baseline and Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in 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
Placebo	-1.07	—
Albiglutide 30 mg Weekly	-1.07	—
Albiglutide 50 mg Weekly	-1.34	—
Open-Label Liraglutide 0.9 mg Daily	-1.17	—

Secondary/registry result

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 24

Time frame:Week 24

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
PlaceboHbA1c <6.5% at Week 24	1	—
HbA1c <7.0% at Week 24	4	—
Albiglutide 30 mg WeeklyHbA1c <6.5% at Week 24	31	—
HbA1c <7.0% at Week 24	92	—
Albiglutide 50 mg WeeklyHbA1c <6.5% at Week 24	47	—
HbA1c <7.0% at Week 24	100	—
Open-Label Liraglutide 0.9 mg DailyHbA1c <6.5% at Week 24	29	—
HbA1c <7.0% at Week 24	66	—

Secondary/registry result

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
PlaceboHbA1c <6.5% at Week 52	14	—
HbA1c <7.0% at Week 52	33	—
Albiglutide 30 mg WeeklyHbA1c <6.5% at Week 52	44	—
HbA1c <7.0% at Week 52	82	—
Albiglutide 50 mg WeeklyHbA1c <6.5% at Week 52	53	—
HbA1c <7.0% at Week 52	85	—
Open-Label Liraglutide 0.9 mg DailyHbA1c <6.5% at Week 52	27	—
HbA1c <7.0% at Week 52	57	—

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Time frame:Baseline and Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Milligrams per deciliter (mg/dL)	95% CI
PlaceboBaseline	159.3	—
Week 24	167.0	—
Change from Baseline at Week 24	7.7	—
Albiglutide 30 mg WeeklyBaseline	157.1	—
Week 24	132.2	—
Change from Baseline at Week 24	-24.9	—
Albiglutide 50 mg WeeklyBaseline	158.7	—
Week 24	128.8	—
Change from Baseline at Week 24	-30.0	—
Open-Label Liraglutide 0.9 mg DailyBaseline	157.2	—
Week 24	128.1	—
Change from Baseline at Week 24	-29.1	—

Secondary/registry result

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
PlaceboBaseline	154.5	—
Week 52	131.7	—
Change from Baseline at Week 52	-22.7	—
Albiglutide 30 mg WeeklyBaseline	154.7	—
Week 52	131.9	—
Change from Baseline at Week 52	-22.8	—
Albiglutide 50 mg WeeklyBaseline	159.8	—
Week 52	126.3	—
Change from Baseline at Week 52	-33.5	—
Open-Label Liraglutide 0.9 mg DailyBaseline	157.4	—
Week 52	127.0	—
Change from Baseline at Week 52	-30.4	—

Secondary/protocol endpoint

Change From Baseline in HbA1c at Week 52

Time frame:Baseline and Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

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 24

Time frame:Week 24

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

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

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Time frame:Baseline and Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

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

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Time to Study Withdrawal Due to Hyperglycemia

Time frame:Baseline through Week 52

Discontinuation due to AE

time to event, event

Posted result

Group	Value (median), Weeks	95% CI
Placebo	NA	NA – NA
Albiglutide 30 mg Weekly	NA	NA – NA
Albiglutide 50 mg Weekly	NA	NA – NA
Open-Label Liraglutide 0.9 mg Daily	NA	NA – NA

Secondary/registry result

Time to Study Withdrawal for Any Reason

Time frame:Baseline through Week 52

Discontinuation due to AE

time to event, event

Posted result

Group	Value (median), Weeks	95% CI
Placebo	NA	NA – NA
Albiglutide 30 mg Weekly	NA	NA – NA
Albiglutide 50 mg Weekly	NA	NA – NA
Open-Label Liraglutide 0.9 mg Daily	NA	NA – NA

Secondary/protocol endpoint

Time to Study Withdrawal Due to Hyperglycemia

Time frame:Baseline through Week 52

Discontinuation due to AE

time to event, event

Secondary/protocol endpoint

Time to Study Withdrawal for Any Reason

Time frame:Baseline through Week 52

Discontinuation due to AE

time to event, event

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.