CompletedPhase 3Results posted

Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus

A Repeat-dose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Efficacy, Safety, Tolerability and Pharmacodynamics, of Albiglutide Liquid Drug Product

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

308

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≤40•HbA1c ≥7%

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 IDNCT02683746

Org study ID200952

Timeline

Milestones

Study first posted2016-02-17estimated

Study start2016-03-16actual

Primary completion2017-04-03actual

Study completion2017-05-15actual

Results first posted2018-05-30actual

Last update posted2019-07-23actual

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

•18 to 80 years of age inclusive

•Historical diagnosis of type 2 diabetes mellitus (T2DM) (at least 3 months), experiencing inadequate glycemic control on current regimen of diet and exercise or on a stable maximal tolerated dose of metformin, maintained for approximately 8 weeks prior to screening.

•HbA1c >=7.0 percent (%) and <=10%.

•Hemoglobin >=11 grams per deciliter (g/dL) (>=110 grams per liter [g/L]) for males and >=10 g/dL (>=100 g/L) for females.

•Body mass index <=40 kilograms per squared meter (kg/m^2)

•Male or female

•Able and willing to provide informed consent.

Exclusion criteria

•Type 1 diabetes mellitus

•History of cancer that has not been in full remission for at least 3 years before screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed).

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.

•History of acute or chronic pancreatitis.

•History of thyroid dysfunction or an abnormal (i.e., outside the normal reference range) thyroid function test assessed by thyroid stimulating hormone at screening.

•Severe gastroparesis, i.e., requiring regular therapy within 6 months before screening.

•History of significant gastrointestinal (GI) surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function

•History of severe hypoglycemia unawareness

•Diabetic complications or any other clinically significant abnormality .

•Clinically significant Cardiovascular (CV) and/or cerebrovascular disease within 3 months before screening

•QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 470 milliseconds (msec).

•ALT >2.5x upper limit of the normal range (ULN) or bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

•Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).

•Estimated glomerular filtration rate (eGFR) <=30 milliliter (mL)/minute (min)/1.73 squared meter (m^2) (calculated using the Modification of Diet in Renal Disease [MDRD] formula) at screening.

•Fasting triglyceride level >750 milligrams per deciliter (mg/dL) at screening.

•Hemoglobinopathy that may affect proper interpretation of HbA1c.

•Medical or psychiatric disorders that would preclude effective participation in study.

•Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (>1 week) in the 6 months following randomization.

•Use of dipeptidyl peptidase-IV inhibitors within the 3 months before randomization.

•History of alcohol or substance abuse within one year before screening.

•Known allergy to albiglutide or any product components (including yeast and human albumin), any other glucagon-like peptide-1 (GLP-1) analogue, or other study medication's excipients OR other contraindications (per the prescribing information) for the use of potential study medications.

•A positive pre-study drug/alcohol screen.

•A positive test for human immunodeficiency virus (HIV) antibody.

•The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

Endpoints (12)

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

4 endpoints

Primary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26

Time frame:Baseline and Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percentage of total hemoglobin	95% CI
Albiglutide Liquid	-1.12	-
Albiglutide Lyophilized	-1.18	-

Mean difference (net)0.0695% CI-0.13 - 0.24p0.0002MMRM model

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Time frame:Baseline and Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · Mmol/L	95% CI
Albiglutide Liquid	-2.22	-
Albiglutide Lyophilized	-1.88	-

Mean difference (net)-0.3495% CI-0.83 - 0.14

Secondary/protocol endpoint

Change From Baseline in HbA1c Over Time

Time frame:Baseline and up to Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percent of total hemoglobin	95% CI
Albiglutide LiquidWeek 4; n= 148, 149	-0.50	-
Week 8; 145, 147	-0.96	-
Week 12; n= 137, 145	-1.15	-
Week 16; n= 136, 144	-1.25	-
Week 20; n= 137, 142	-1.24	-
Week 26; n= 138, 141	-1.16	-
Albiglutide LyophilizedWeek 4; n= 148, 149	-0.54	-
Week 8; 145, 147	-1.02	-
Week 12; n= 137, 145	-1.23	-
Week 16; n= 136, 144	-1.27	-
Week 20; n= 137, 142	-1.26	-
Week 26; n= 138, 141	-1.17	-

Mean difference (net)0.0395% CI-0.07 - 0.13p<0.0001MMRM model

Mean difference (net)0.0795% CI-0.07 - 0.20p<0.0001MMRM model

Mean difference (net)0.0895% CI-0.08 - 0.24p<0.0001MMRM model

Mean difference (net)0.0295% CI-0.16 - 0.20p<0.0001MMRM model

Mean difference (net)0.0295% CI-0.15 - 0.19p<0.0001MMRM model

Mean difference (net)0.0195% CI-0.17 - 0.20p<0.0001MMRM model

Secondary/protocol endpoint

Change From Baseline in FPG Over Time

Time frame:Baseline and up to Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · Mmol/L	95% CI
Albiglutide LiquidWeek 1; n= 148, 144	-1.04	-
Week 2; n= 143, 145	-1.52	-
Week 3; n= 145, 140	-1.71	-
Week 4; n= 142, 145	-1.93	-
Week 5; n= 146, 143	-2.04	-
Week 6; n= 145, 145	-2.07	-
Week 7; n= 146, 144	-1.93	-
Week 8; n= 143, 141	-2.19	-
Week 9; n= 142, 141	-2.05	-
Week 10; n= 141, 142	-2.03	-
Week 11; n= 141, 139	-2.01	-
Week 12; n= 137, 137	-2.16	-
Week 13; n= 140, 136	-2.04	-
Week 16; n= 140, 140	-2.02	-
Week 20; n= 139, 134	-1.87	-
Week 26; n= 141, 136	-2.22	-
Albiglutide LyophilizedWeek 1; n= 148, 144	-1.29	-
Week 2; n= 143, 145	-1.77	-
Week 3; n= 145, 140	-1.70	-
Week 4; n= 142, 145	-1.91	-
Week 5; n= 146, 143	-2.23	-
Week 6; n= 145, 145	-2.22	-
Week 7; n= 146, 144	-2.20	-
Week 8; n= 143, 141	-2.38	-
Week 9; n= 142, 141	-2.08	-
Week 10; n= 141, 142	-2.17	-
Week 11; n= 141, 139	-2.12	-
Week 12; n= 137, 137	-2.19	-
Week 13; n= 140, 136	-2.09	-
Week 16; n= 140, 140	-2.09	-
Week 20; n= 139, 134	-1.90	-
Week 26; n= 141, 136	-1.88	-

Mean difference (net)0.2595% CI-0.15 - 0.65

Mean difference (net)0.2595% CI-0.20 - 0.69

Mean difference (net)-0.0195% CI-0.42 - 0.40

Mean difference (net)-0.0395% CI-0.42 - 0.36

Mean difference (net)0.1995% CI-0.19 - 0.57

Mean difference (net)0.1595% CI-0.26 - 0.55

Mean difference (net)0.2795% CI-0.16 - 0.71

Mean difference (net)0.1995% CI-0.22 - 0.60

Mean difference (net)0.0395% CI-0.41 - 0.47

Mean difference (net)0.1595% CI-0.28 - 0.57

Mean difference (net)0.1195% CI-0.34 - 0.56

Mean difference (net)0.0395% CI-0.41 - 0.46

Mean difference (net)0.0595% CI-0.47 - 0.57

Mean difference (net)0.0695% CI-0.41 - 0.54

Mean difference (net)0.0395% CI-0.47 - 0.53

Mean difference (net)-0.3495% CI-0.83 - 0.14

Safety / tolerability / PK

8 endpoints

Secondary/protocol endpoint

Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs)

Time frame:Up to Week 26

Serious AEs (any)

event count, event

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

Posted result

Group	Number · Participnats	95% CI
Albiglutide LiquidAEs	101	-
SAEs	7	-
Albiglutide LyophilizedAEs	94	-
SAEs	9	-

Secondary/protocol endpoint

Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC)

Time frame:Up to Week 26

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide LiquidALT; >3*ULN	0	-
Albumin; >5 g/L below LLN	0	-
Albumin; >5 g/L above ULN	0	-
Alk.phosph.; >3*ULN	0	-
AST; >3*ULN	1	-
Bilirubin; >1.5*ULN	0	-
Calcium; <1.8 mmol/L	0	-
Calcium; >3.0 mmol/L	1	-
CO2; <16 mmol/L	1	-
CO2; >40 mmol/L	0	-
Creatinine; >159 µmol/L	1	-
Direct bilirubin; >1.35ULN	0	-
GGT; >3*ULN	1	-
Potassium; >0.5 mmol/L below LLN	0	-
Potassium; >1.0 mmol/L above ULN	0	-
Protein; >15 g/L below LLN	0	-
Protein; >15 g/L above ULN	0	-
Sodium; >5 mmol/L below LLN	1	-
Sodium; >5 mmol/L above ULN	0	-
Urate; >654 µmol/L	1	-
Urea; >2*ULN	0	-
Albiglutide LyophilizedALT; >3*ULN	1	-
Albumin; >5 g/L below LLN	0	-
Albumin; >5 g/L above ULN	0	-
Alk.phosph.; >3*ULN	0	-
AST; >3*ULN	1	-
Bilirubin; >1.5*ULN	2	-
Calcium; <1.8 mmol/L	0	-
Calcium; >3.0 mmol/L	0	-
CO2; <16 mmol/L	6	-
CO2; >40 mmol/L	0	-
Creatinine; >159 µmol/L	1	-
Direct bilirubin; >1.35ULN	1	-
GGT; >3*ULN	4	-
Potassium; >0.5 mmol/L below LLN	1	-
Potassium; >1.0 mmol/L above ULN	1	-
Protein; >15 g/L below LLN	0	-
Protein; >15 g/L above ULN	0	-
Sodium; >5 mmol/L below LLN	0	-
Sodium; >5 mmol/L above ULN	2	-
Urate; >654 µmol/L	1	-
Urea; >2*ULN	0	-

Secondary/protocol endpoint

Number of Participants With Hematology Parameters of PCC

Time frame:Up to Week 26

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide LiquidHematocrit; >0.05 (fraction of 1) below LLN	2	-
Hematocrit; >0.04 (fraction of 1) above ULN	5	-
Hb; >20 g/L below LLN	3	-
Hb; >10 g/L above ULN	2	-
Lymphocytes; <0.5*LLN	0	-
Neutrophils; <1 GI/L	1	-
Platelets; <80 GI/L	0	-
Platelets; >500 GI/L	1	-
Albiglutide LyophilizedHematocrit; >0.05 (fraction of 1) below LLN	6	-
Hematocrit; >0.04 (fraction of 1) above ULN	2	-
Hb; >20 g/L below LLN	9	-
Hb; >10 g/L above ULN	2	-
Lymphocytes; <0.5*LLN	0	-
Neutrophils; <1 GI/L	0	-
Platelets; <80 GI/L	0	-
Platelets; >500 GI/L	1	-

Secondary/protocol endpoint

Number of Participants With Vital Signs of PCC

Time frame:Up to Week 34

threshold achievement, event

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

Posted result

Group	Number · Participants	95% CI
Albiglutide LiquidSBP: <100 mmHg	18	-
SBP; >170 mmHg	11	-
DBP; <50 mmHg	0	-
DBP; > 110 mmHg	3	-
Pulse rate; < 50 bpm	5	-
Pulse rate; > 120 bpm	1	-
Albiglutide LyophilizedSBP: <100 mmHg	16	-
SBP; >170 mmHg	13	-
DBP; <50 mmHg	0	-
DBP; > 110 mmHg	3	-
Pulse rate; < 50 bpm	2	-
Pulse rate; > 120 bpm	0	-

Secondary/protocol endpoint

Number of Participants With Electrocardiogram (ECG) Parameters of PCC

Time frame:Up to Week 26

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide LiquidECG mean heart rate; <50 bpm	2	-
ECG mean heart rate; >120 bpm	1	-
PR interval; >300 msec	1	-
QRS duration; >200 msec	0	-
QTcF interval; >=500 msec	0	-
Albiglutide LyophilizedECG mean heart rate; <50 bpm	2	-
ECG mean heart rate; >120 bpm	0	-
PR interval; >300 msec	2	-
QRS duration; >200 msec	0	-
QTcF interval; >=500 msec	0	-

Secondary/protocol endpoint

Number of Participants With Positive Result for Anti-albiglutide Antibody

Time frame:Up to Week 34

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide Liquid	17	-
Albiglutide Lyophilized	16	-

Secondary/protocol endpoint

Number of Participants With Injection Site Reactions (ISR)

Time frame:Up to Week 34

event count, event

Posted result

Group	Number · Participants	95% CI
Albiglutide Liquid	17	-
Albiglutide Lyophilized	18	-

Secondary/protocol endpoint

Trough Plasma Concentration of Albiglutide Over Time

Time frame:Pre-dose at Week 12 and Week 26

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Mean · Nanograms per milliliter (ng/mL)	95% CI
Albiglutide LiquidWeek 12; n= 127, 130	3996.9	-
Week 26; n= 127, 127	4196.6	-
Albiglutide LyophilizedWeek 12; n= 127, 130	3927.1	-
Week 26; n= 127, 127	3929.1	-

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

Efficacy and safety of an albiglutide liquid formulation compared with the lyophilized formulation: A 26-week randomized, double-blind, repeat-dose study in patients with type 2 diabetes mellitus.
Diabetes research and clinical practice2019 Jun (month)PMID31004676doi:10.1016/j.diabres.2019.04.018via CT.gov background

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.