CompletedPhase 3Results posted

Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes

A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

386

Recruiting sites

Actual enrollment

1,049

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 IDNCT00838903

Org study ID112753

Timeline

Milestones

Study first posted2009-02-09estimated

Results first posted2014-05-16estimated

Last update posted2017-01-09estimated

Study start2009-02 (month precision)

Primary completion2012-01actual (month precision)

Study completion2013-04actual (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

•current symptomatic heart failure (NYHA Class III or IV)

Endpoints (9)

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

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 104

Time frame:Baseline and Week 104

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · Kilograms	95% CI
Placebo Plus Metformin	-1.00	-
Sitagliptin 100 mg Plus Metformin	-0.86	-
Glimepiride 2 mg Plus Metformin	1.17	-
Albiglutide 30 mg Plus Metformin	-1.21	-

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

Group	Mean · Kilograms	95% CI
Placebo Plus Metformin	-3.61	-
Sitagliptin 100 mg Plus Metformin	-2.05	-
Glimepiride 2 mg Plus Metformin	0.98	-
Albiglutide 30 mg Plus Metformin	-2.31	-

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104

Time frame:Baseline and Week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percentage of HbA1c in the blood	95% CI
Placebo Plus Metformin	0.27	-
Sitagliptin 100 mg Plus Metformin	-0.28	-
Glimepiride 2 mg Plus Metformin	-0.36	-
Albiglutide 30 mg Plus Metformin	-0.63	-

Mean difference (net)-0.9195% CI-1.16 - -0.65ANCOVA

Mean difference (net)-0.3595% CI-0.53 - -0.17ANCOVA

Mean difference (net)-0.2795% CI-0.45 - -0.09ANCOVA

p<0.0001t-test, 2 sided

p<0.0001t-test, 1 sided

p0.0001t-test, 2 sided

p0.0033t-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

Group	Mean · Percentage of HbA1c in the blood	95% CI
Placebo Plus Metformin	-0.46	-
Sitagliptin 100 mg Plus Metformin	-0.56	-
Glimepiride 2 mg Plus Metformin	-0.59	-
Albiglutide 30 mg Plus Metformin	-0.88	-

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104

Time frame:Baseline and Week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · Millimoles per liter (mmol/L)	95% CI
Placebo Plus Metformin	0.55	-
Sitagliptin 100 mg Plus Metformin	-0.12	-
Glimepiride 2 mg Plus Metformin	-0.41	-
Albiglutide 30 mg Plus Metformin	-0.98	-

Secondary/protocol endpoint

Change From Baseline in FPG at Week 156

Time frame:Baseline and Week 156

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Mean · Millimoles per liter (mmol/L)	95% CI
Placebo Plus Metformin	-0.11	-
Sitagliptin 100 mg Plus Metformin	-0.50	-
Glimepiride 2 mg Plus Metformin	-0.71	-
Albiglutide 30 mg Plus Metformin	-1.30	-

Secondary/protocol endpoint

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104

Time frame:Week 104

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · Participants	95% CI
Placebo Plus MetforminHbA1c <6.5%	7	-
HbA1c <7.0%	15	-
HbA1c <7.5%	27	-
Sitagliptin 100 mg Plus MetforminHbA1c <6.5%	45	-
HbA1c <7.0%	94	-
HbA1c <7.5%	132	-
Glimepiride 2 mg Plus MetforminHbA1c <6.5%	40	-
HbA1c <7.0%	94	-
HbA1c <7.5%	147	-
Albiglutide 30 mg Plus MetforminHbA1c <6.5%	50	-
HbA1c <7.0%	113	-
HbA1c <7.5%	172	-

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

Group	Number · Participants	95% CI
Placebo Plus MetforminHbA1c <6.5%	4	-
HbA1c <7.0%	7	-
HbA1c <7.5%	13	-
Sitagliptin 100 mg Plus MetforminHbA1c <6.5%	23	-
HbA1c <7.0%	44	-
HbA1c <7.5%	69	-
Glimepiride 2 mg Plus MetforminHbA1c <6.5%	15	-
HbA1c <7.0%	44	-
HbA1c <7.5%	69	-
Albiglutide 30 mg Plus MetforminHbA1c <6.5%	31	-
HbA1c <7.0%	69	-
HbA1c <7.5%	90	-

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

Group	Median · Weeks	95% CI
Placebo Plus Metformin	67.71	53.14 - 122.14
Sitagliptin 100 mg Plus Metformin	NA	NA - NA
Glimepiride 2 mg Plus Metformin	NA	NA - NA
Albiglutide 30 mg Plus Metformin	NA	NA - NA

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

Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy.
Diabetes research and clinical practice2017 Sep (month)PMID28683300doi:10.1016/j.diabres.2017.06.013via clinicaltrials gov reference derived + pubmed nct search

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.