CompletedPhase 2Results posted

Pharmacokinetics/Pharmacodynamics of Albiglutide

A Multidose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Pharmacokinetics and Pharmacodynamics of Albiglutide

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

283

Study population

Type 2 diabetes

Eligibility highlights

•BMI 20-45

Primary endpoints

•AUC•Cmax of Albiglutide in the BE Phase

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 IDNCT01357889

Org study ID114856

Timeline

Milestones

Study first posted2011-05-23estimated

Results first posted2014-05-23estimated

Last update posted2017-01-09estimated

Study start2011-07 (month precision)

Primary completion2012-10actual (month precision)

Study completion2012-10actual (month precision)

Assets

Investigational agents

Albiglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects with a historical diagnosis of type 2 diabetes mellitus who are experiencing inadequate glycemic control on their current regimen of diet and exercise or on a stable dose of metformin

•Body mass index ≥20 kg/m2 and ≤45 kg/m2

•Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)

•Thyroid-stimulating hormone level is normal or clinically euthyroid

•Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception.

Exclusion criteria

•Current ongoing symptomatic biliary disease or history of pancreatitis

•History of significant GI surgery

•Recent clinically significant cardiovascular and/or cerebrovascular disease

•History of human immunodeficiency virus infection

•History of, or current hepatic disease

•History of alcohol or substance abuse

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

•History of type 1 diabetes

•Receipt of any investigational drug within the 30 days, or 5 half-lives whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of any GLP-1 agents including albiglutide

•History of, or family history of thyroid disease

Endpoints (18)

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

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17

Time frame:Baseline and Week 17

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percentage of HbA1c in blood	95% CI
Albiglutide Process 2	-0.75	-
Albiglutide Process 3	-0.84	-

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17

Time frame:Baseline and Week 17

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · millimoles per liter	95% CI
Albiglutide Process 2	-1.11	-
Albiglutide Process 3	-1.21	-

Safety / tolerability / PK

16 endpoints

Primary/protocol endpoint

Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase

Time frame:Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · nanograms*hour/milliliter	95% CI
Albiglutide Process 2	496190.200	-
Albiglutide Process 3	464985.355	-

Ratio of geometric lsms (p3:p2)0.93790% CI0.842 - 1.042ANOVA

Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase

Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · nanograms per milliliter (ng/mL)	95% CI
Albiglutide Process 2	1881.053	-
Albiglutide Process 3	1743.053	-

Ratio of geometric lsms (p3:p2)0.92790% CI0.813 - 1.056ANOVA

Secondary/protocol endpoint

Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)

Time frame:Immediately pre-dose at Week 5, Week 9, Week 13, Week 17 (End of Treatment [EOT]), and Week 25 (Follow-up)

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Mean · ng/mL	95% CI
Albiglutide Process 2Week 5, n=131, 135	10.55	-
Week 9, n=127, 130	2420.95	-
Week 13, n=126, 127	2352.94	-
Week 17 (EOT), n=123, 125	2360.19	-
Week 25 (follow-up), n=121, 123	28.20	-
Albiglutide Process 3Week 5, n=131, 135	8.70	-
Week 9, n=127, 130	2519.62	-
Week 13, n=126, 127	2356.27	-
Week 17 (EOT), n=123, 125	2436.63	-
Week 25 (follow-up), n=121, 123	14.45	-

Secondary/protocol endpoint

Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase

Time frame:Baseline, Week 5, Week 9, Week 13, Week 17, and Week 25 (Follow-up)

Immunogenicity (ADA)

descriptive

Posted result

Group	Number · Participants	95% CI
Albiglutide Process 2Baseline, n=139, 140	1	-
Week 5, n=131, 132	1	-
Week 9, n=124, 120	0	-
Week 13, n=119, 122	1	-
Week 17, n=119, 127	0	-
Week 25, n=116, 118	0	-
Albiglutide Process 3Baseline, n=139, 140	0	-
Week 5, n=131, 132	0	-
Week 9, n=124, 120	0	-
Week 13, n=119, 122	3	-
Week 17, n=119, 127	5	-
Week 25, n=116, 118	2	-

Secondary/protocol endpoint

AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase

Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · nanograms*hour/milliliter	95% CI
Albiglutide Process 2AUC (0-last), n=84, 80	447294.0	-
AUC (0-inf), n=75, 74	496190.2	-
Albiglutide Process 3AUC (0-last), n=84, 80	426263.5	-
AUC (0-inf), n=75, 74	464985.4	-

Secondary/protocol endpoint

Tmax and Tlag of Albiglutide in the BE Phase

Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Tmax

descriptive

Posted result

Group	Median · Hours	95% CI
Albiglutide Process 2tmax, n=85, 80	95.50	23.4 - 214.3
tlag, n=84, 80	0.00	0.0 - 24.1
Albiglutide Process 3tmax, n=85, 80	96.08	20.5 - 217.8
tlag, n=84, 80	0.00	0.0 - 24.1

Secondary/protocol endpoint

Cmax of Albiglutide in the BE Phase

Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · ng/mL	95% CI
Albiglutide Process 2	1881.05	-
Albiglutide Process 3	1743.05	-

Secondary/protocol endpoint

t1/2 of Albiglutide in the BE Phase

Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

Half-life

descriptive

Posted result

Group	Geometric mean · Hours	95% CI
Albiglutide Process 2	106.42	-
Albiglutide Process 3	113.83	-

Secondary/protocol endpoint

Apparent Clearance of Albiglutide in the BE Phase

Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

descriptive

Posted result

Group	Geometric mean · Liters per hour	95% CI
Albiglutide Process 2	0.06046	-
Albiglutide Process 3	0.06452	-

Secondary/protocol endpoint

Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase

Time frame:Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose

descriptive

Posted result

Group	Geometric mean · Liters	95% CI
Albiglutide Process 2	9.283	-
Albiglutide Process 3	10.595	-

Secondary/protocol endpoint

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

Time frame:From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinued active participation in the study

Treatment-emergent AEs (any)

event count, event

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

Posted result

Group	Number · Participants	95% CI
Albiglutide Process 2Any AE	106	-
Any SAE	5	-
Albiglutide Process 3Any AE	91	-
Any SAE	1	-

Secondary/protocol endpoint

Number of Participants With Indicated Adverse Events of Special Interest

Time frame:From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinue active participation in the study

event count, event

Posted result

Group	Number · Participants	95% CI
Albiglutide Process 2Any cardiovascular AE	15	-
Any hypoglycemic AE	11	-
Any thyroid AE	2	-
Any GI AE	36	-
Any SAR AE	1	-
Any ISR AE	13	-
Any hepatobiliary AE	2	-
Any investigations	5	-
Any pancreatitis AE	0	-
Any diabetic retinopathy AE	0	-
Albiglutide Process 3Any cardiovascular AE	9	-
Any hypoglycemic AE	7	-
Any thyroid AE	1	-
Any GI AE	32	-
Any SAR AE	0	-
Any ISR AE	7	-
Any hepatobiliary AE	2	-
Any investigations	10	-
Any pancreatitis AE	0	-
Any diabetic retinopathy AE	0	-

Secondary/protocol endpoint

Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit

Time frame:Week 1 through Week 25

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide Process 2Hematocrit >0.1 decrease	1	-
Hemoglobin >25 g/L	1	-
Albiglutide Process 3Hematocrit >0.1 decrease	0	-
Hemoglobin >25 g/L	1	-

Secondary/protocol endpoint

Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit

Time frame:Week 1 through Week 25

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Posted result

Group	Number · Participants	95% CI
Albiglutide Process 2SBP, decrease >30 mmHg	18	-
SBP, increase >30 mmHg	10	-
DBP, decrease >20 mmHg	19	-
DBP, increase >20 mmHg	7	-
Heart rate, decrease >30 bpm	1	-
Heart rate, increase >30 bpm	5	-
Albiglutide Process 3SBP, decrease >30 mmHg	16	-
SBP, increase >30 mmHg	10	-
DBP, decrease >20 mmHg	16	-
DBP, increase >20 mmHg	8	-
Heart rate, decrease >30 bpm	4	-
Heart rate, increase >30 bpm	4	-

Secondary/protocol endpoint

Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17

Time frame:Screening and Week 17

categorical status, descriptive

Posted result

Group	Number · Participants	95% CI
Albiglutide Process 2Skin, Improved	2	-
Skin, No Change	112	-
Skin, Worsened	6	-
Skin, Not done	0	-
Head, Eyes, ENT, Improved	3	-
Head, Eyes, ENT, No Change	115	-
Head, Eyes, ENT, Worsened	2	-
Head, Eyes, ENT, Not done	0	-
Cardiovascular system, Improved	1	-
Cardiovascular system, No Change	119	-
Cardiovascular system, Worsened	0	-
Cardiovascular system, Not done	0	-
Respiratory system, Improved	0	-
Respiratory system, No Change	120	-
Respiratory system, Worsened	0	-
Respiratory system, Not done	0	-
Abdomen (Liver and Spleen), Improved	0	-
Abdomen (Liver and Spleen), No Change	120	-
Abdomen (Liver and Spleen), Worsened	0	-
Abdomen (Liver and Spleen), Not done	0	-
Lymph Nodes, Improved	0	-
Lymph Nodes, No Change	120	-
Lymph Nodes, Worsened	0	-
Lymph Nodes, Not done	0	-
CNS, Improved	1	-
CNS, No Change	118	-
CNS, Worsened	1	-
CNS, Not done	0	-
Extremities, Improved	4	-
Extremities, No Change	114	-
Extremities, Worsened	2	-
Extremities, Not done	0	-
Thyroid, Improved	0	-
Thyroid, No Change	120	-
Thyroid, Worsened	0	-
Thyroid, Not done	0	-
Albiglutide Process 3Skin, Improved	3	-
Skin, No Change	117	-
Skin, Worsened	4	-
Skin, Not done	1	-
Head, Eyes, ENT, Improved	0	-
Head, Eyes, ENT, No Change	122	-
Head, Eyes, ENT, Worsened	2	-
Head, Eyes, ENT, Not done	1	-
Cardiovascular system, Improved	0	-
Cardiovascular system, No Change	124	-
Cardiovascular system, Worsened	0	-
Cardiovascular system, Not done	1	-
Respiratory system, Improved	1	-
Respiratory system, No Change	123	-
Respiratory system, Worsened	0	-
Respiratory system, Not done	1	-
Abdomen (Liver and Spleen), Improved	0	-
Abdomen (Liver and Spleen), No Change	121	-
Abdomen (Liver and Spleen), Worsened	3	-
Abdomen (Liver and Spleen), Not done	1	-
Lymph Nodes, Improved	0	-
Lymph Nodes, No Change	123	-
Lymph Nodes, Worsened	0	-
Lymph Nodes, Not done	2	-
CNS, Improved	2	-
CNS, No Change	122	-
CNS, Worsened	0	-
CNS, Not done	1	-
Extremities, Improved	1	-
Extremities, No Change	118	-
Extremities, Worsened	4	-
Extremities, Not done	2	-
Thyroid, Improved	0	-
Thyroid, No Change	123	-
Thyroid, Worsened	0	-
Thyroid, Not done	2	-

Secondary/protocol endpoint

Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit

Time frame:Week 1 through Week 25

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide Process 2QRS, Increase of > 25% or >50%, n=139, 137	1	-
QTcF, >=60 msec, n=139, 137	0	-
PR, Increase of > 25% or >50%, n=137, 135	0	-
Albiglutide Process 3QRS, Increase of > 25% or >50%, n=139, 137	0	-
QTcF, >=60 msec, n=139, 137	0	-
PR, Increase of > 25% or >50%, n=137, 135	0	-

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

Clinical pharmacology of albiglutide, a GLP-1 receptor agonist.
Postgraduate medicine2014 Nov (month)PMID25387217doi:10.3810/pgm.2014.11.2836via 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.