GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01098461

CompletedPhase 2Results posted

Dose Ranging Study of Albiglutide in Japanese Subjects

A Dose Finding Study of GSK716155 Versus Placebo in the Treatment of Type 2 Diabetes Mellitus

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

215

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 18-35•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 IDNCT01098461

Org study ID110932

Timeline

Milestones

Study first posted2010-04-02estimated

Results first posted2014-07-01estimated

Last update posted2017-01-13estimated

Study start2010-04 (month precision)

Primary completion2011-05actual (month precision)

Study completion2011-05actual (month precision)

Assets

Investigational agents

Albiglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subject with a historical diagnosis of type 2 diabetes mellitus who is currently treated with diet and exercise only or one OAD

•BMI ≥18 kg/m2 and <35 kg/m2 at Screening

•HbA1c between 7.0% and 10.0%, inclusive

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

•Female subjects of childbearing potential must be practicing adequate contraception .

•Able and willing to monitor his/her own blood glucose concentrations with a home glucose monitor.

•Able and willing to provide written informed consent

Exclusion criteria

•Diagnosis of type 1 diabetes mellitus

•Uncorrected thyroid dysfunction

•Previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening

•Clinically significantly cardiovascular and/or cerebrovascular disease including, but not limited to the following:

–Previous history of stroke or transient ischemic attack

–Active, unstable coronary heart disease within the past six months before Screening

–Documented myocardial infarction within one year before Screening

–Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within one year before Screening

–Unstable angina

–Clinically significant arrhythmia or valvular heart disease

–Current heart failure NYHA class II to IV

–Resting systolic pressure >160 mm Hg or diastolic pressure >95 mm Hg at Screening

–ECG criteria at Screening

•Heart rate: <40 and >110 bpm

•PR interval: <120 and > 210 msec

•QRS interval: <70 and >120 msec

•QTc interval (Bazett): >450 msec or >480 msec with bundle branch block

•Fasting triglyceride level >400 mg/dL at Screening

•AST or ALT >2xULN, ALP and bilirubin >1.5xULN (except known Gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin <35% of total bilirubin)

•If female, is currently lactating, within 6 weeks post-partum, pregnant, or actively trying to become pregnant

•Has significant renal disease as manifested by one or more of the following:

–Creatinine clearance at screening <60 mL/min (calculated by Cockcroft-Gault formula) at Screening

–Known loss of a kidney either by surgical ablation, injury or disease level

•A hemoglobinopathy that may affect determination of HbA1c level

•History of treated diabetic gastroparesis

•History of significant gastrointestinal surgery, including gastric bypass and banding, or surgeries thought to significantly affect upper gastrointestinal function

•Current ongoing symptomatic biliary disease or history of acute/chronic pancreatitis.

•Lipase and amylase at Screening > ULN

•Severe diabetic neuropathy, preproliferative retinopathy or proliferative retinopathy, history of ketoacidosis or hyperosmolar coma

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

•Acute or chronic history of liver disease, positive hepatitis B surface antigen (HBsAg) or positive hepatitis C testing at Screening

•Current and history of alcohol or substance abuse

•Clinically significant anaemia or any other abnormal haematological profile that is considered by the investigator to be clinically significant

•Prior use of a GLP-1 analog

•Known allergy to any formulation excipients, or Baker's yeast, or history of drug, or other allergy which, in the opinion of the responsible study physician, contradicts participation

•History of or family history of medullary carcinoma of the thyroid.

•History of or family history of multiple endocrine neoplasia type 2

•Receipt of any investigational drug within the 12 weeks before Screening

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

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 4, 8, 12, and 16

Time frame:Baseline; Week 4, Week 8, Week 12, and Week 16

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilograms	95% CI
PlaceboWeek 4	-0.16	—
Week 8	-0.29	—
Week 12	-0.43	—
Week 16	-0.65	—
Albiglutide 15 mg WeeklyWeek 4	-0.36	—
Week 8	-0.06	—
Week 12	0.09	—
Week 16	0.43	—
Albiglutide 30 mg WeeklyWeek 4	-0.25	—
Week 8	-0.46	—
Week 12	-0.20	—
Week 16	-0.20	—
Albiglutide 30 mg Every Other WeekWeek 4	-0.02	—
Week 8	-0.25	—
Week 12	-0.22	—
Week 16	-0.08	—

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16

Time frame:Baseline and Week 16

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	0.28	—
Albiglutide 15 mg Weekly	-0.61	—
Albiglutide 30 mg Weekly	-1.27	—
Albiglutide 30 mg Every Other Week	-0.82	—

Mean Difference (Final Values)-0.8995% CI-1.22 – -0.57p<0.0001t-test, 2 sided

Mean Difference (Final Values)-1.5595% CI-1.88 – -1.23p<0.0001t-test, 2 sided

Mean Difference (Final Values)-1.1095% CI-1.43 – -0.78p<0.0001t-test, 2 sided

Secondary/protocol endpoint

Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16

Time frame:Baseline; Week 4, Week 8, Week 12, and Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c in the blood	95% CI
PlaceboWeek 4	0.03	—
Week 8	0.20	—
Week 12	0.24	—
Week 16	0.27	—
Albiglutide 15 mg WeeklyWeek 4	-0.33	—
Week 8	-0.59	—
Week 12	-0.71	—
Week 16	-0.63	—
Albiglutide 30 mg WeeklyWeek 4	-0.61	—
Week 8	-1.07	—
Week 12	-1.26	—
Week 16	-1.29	—
Albiglutide 30 mg Every Other WeekWeek 4	-0.36	—
Week 8	-0.74	—
Week 12	-0.84	—
Week 16	-0.84	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16

Time frame:Baseline; Week 4, Week 8, Week 12, and Week 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
PlaceboWeek 4	0.30	—
Week 8	0.41	—
Week 12	0.38	—
Week 16	0.50	—
Albiglutide 15 mg WeeklyWeek 4	-1.54	—
Week 8	-1.54	—
Week 12	-1.25	—
Week 16	-0.77	—
Albiglutide 30 mg WeeklyWeek 4	-2.27	—
Week 8	-2.27	—
Week 12	-1.92	—
Week 16	-1.92	—
Albiglutide 30 mg Every Other WeekWeek 4	-1.32	—
Week 8	-1.19	—
Week 12	-1.06	—
Week 16	-0.78	—

Secondary/protocol endpoint

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16

Time frame:Week 4, Week 8, Week 12, and Week 16

threshold achievement, improvement

componentsHbA1c <6.5% achievement, HbA1c <7.0% achievement

Posted result

Group	Value (number), Participants	95% CI
PlaceboHbA1c <6.5%, Week 4	0	—
HbA1c <6.5%, Week 8	0	—
HbA1c <6.5%, Week 12	0	—
HbA1c <6.5%, Week 16	0	—
HbA1c <7%, Week 4	2	—
HbA1c <7%, Week 8	4	—
HbA1c <7%, Week 12	3	—
HbA1c <7%, Week 16	3	—
Albiglutide 15 mg WeeklyHbA1c <6.5%, Week 4	1	—
HbA1c <6.5%, Week 8	5	—
HbA1c <6.5%, Week 12	6	—
HbA1c <6.5%, Week 16	5	—
HbA1c <7%, Week 4	7	—
HbA1c <7%, Week 8	12	—
HbA1c <7%, Week 12	12	—
HbA1c <7%, Week 16	9	—
Albiglutide 30 mg WeeklyHbA1c <6.5%, Week 4	2	—
HbA1c <6.5%, Week 8	15	—
HbA1c <6.5%, Week 12	19	—
HbA1c <6.5%, Week 16	18	—
HbA1c <7%, Week 4	19	—
HbA1c <7%, Week 8	27	—
HbA1c <7%, Week 12	32	—
HbA1c <7%, Week 16	34	—
Albiglutide 30 mg Every Other WeekHbA1c <6.5%, Week 4	1	—
HbA1c <6.5%, Week 8	5	—
HbA1c <6.5%, Week 12	8	—
HbA1c <6.5%, Week 16	8	—
HbA1c <7%, Week 4	9	—
HbA1c <7%, Week 8	18	—
HbA1c <7%, Week 12	19	—
HbA1c <7%, Week 16	21	—

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Mean Clearance of Albiglutide

Time frame:Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24

descriptive

Posted result

Group	Value (mean), milliliters per hour	95% CI
Albiglutide 15/30 mg Weekly or 30 mg Every Other Week	47.8	45.7 – 49.9

Secondary/protocol endpoint

Mean Volume of Distribution of Albiglutide

Time frame:Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24

descriptive

Posted result

Group	Value (mean), Liters	95% CI
Albiglutide 15/30 mg Weekly or 30 mg Every Other Week	9.34	8.71 – 10.0

Secondary/protocol endpoint

Mean Absorption Rate of Albiglutide

Time frame:Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24

descriptive

Posted result

Group	Value (mean), hour^-1	95% CI
Albiglutide 15/30 mg Weekly or 30 mg Every Other Week	0.0154	0.0134 – 0.0183

Secondary/protocol endpoint

Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG

Time frame:Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24

descriptive

Posted result

Group	Value (mean), nanograms per milliliter	95% CI
Albiglutide 15/30 mg Weekly or 30 mg Every Other WeekHbA1c	3360	2440 – 5260
FPG	3850	1420 – 6330

Publications (2)

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
A randomized dose-finding study demonstrating the efficacy and tolerability of albiglutide in Japanese patients with type 2 diabetes mellitus.
Current medical research and opinion2014 Jun (month)PMID24552155doi:10.1185/03007995.2014.896327via 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.