DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01475734

CompletedPhase 2Results posted

Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes

A Single-site, Randomized, Double-blind, Placebo-controlled, Parallel-group, Stepped Glucose Clamp Study to Assess the Effects of Albiglutide on Counter-regulatory Hormone Responses and Recovery From Hypoglycemia in Subjects With Type 2 Diabetes Mellitus.

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

44

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 28-40•HbA1c ≤10%

Primary endpoint

•Glucagon Concentration

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 IDNCT01475734
Org study ID108372

Timeline

Milestones

Study first posted2011-11-21estimated
Results first posted2014-05-16estimated
Last update posted2017-01-11estimated
Study start2011-12 (month precision)
Primary completion2012-07actual (month precision)
Study completion2012-07actual (month precision)

Assets

Investigational agents

Albiglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than 10 years before Screening
•HbA1c <10% at Screening for subjects who do not require washout of existing OAD or <9% at Screening for subjects who do require washout from existing OAD
•Body mass index in range 28 kg/m2 to40 kg/m2

Exclusion criteria

•History of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis
•History of significant gastrointestinal surgery,
•History of significant cardiovascular disease
•History of a seizure disorder
•Documented hypertension or hypotension
•Use of oral antidiabetic agents, except for metformin, within 14 days before investigational product administration.
•Current hepatic disease or abnormal liver function tests
•Positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus infection 1 or 2
•History of regular alcohol consumption (exceeding 7 drinks/week for women or 14 drinks/week for men)
•Female subject is pregnant (confirmed by laboratory testing), lactating, or less than 6 weeks postpartum
•Known allergy to any GLP-1 analog or excipients of albiglutide, Baker's yeast, or insulin
•History of type 1 diabetes,
•Prior exposure to GLP-1 agents, including albiglutide
•Blood donation over 500 mL within 8 weeks before Screening

Endpoints (11)

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
5
Cardiometabolic biomarkers
3
Safety / tolerability / PK
3

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

Glucagon Concentration (Nanomoles Per Liter [Nmol/L]) During the Hypoglycemic Periods of the Glucose Clamp Procedure

Time frame:Day 4

concentration, descriptive

Posted result

GroupValue (geometric_mean), Nanomoles per liter (nmol/L)95% CI
Albiglutide 50 mg0 hr, n=20, 210.03780—
1 hr, n=20, 210.03780—
1 hr 15 min, n=20, 210.03783—
1 hr 45 min, n=20, 210.03780—
2 hr, n=20, 200.03805—
2 hr 45 min, n=20, 210.03876—
3 hr, n=20, 210.03808—
3 hr 30 min, n=20, 210.04296—
3 hr 45 min, n=20, 210.04072—
4 hr 15 min, n=20, 210.03976—
4 hr 30 min, n=20, 210.03899—
4 hr 45 min, n=20, 210.03936—
5 hr, n=20, 210.03780—
5 hr 15 min, n=20, 210.03809—
5 hr 30 min, n=20, 210.03780—
Placebo0 hr, n=20, 210.03805—
1 hr, n=20, 210.03780—
1 hr 15 min, n=20, 210.03780—
1 hr 45 min, n=20, 210.03780—
2 hr, n=20, 200.03780—
2 hr 45 min, n=20, 210.03780—
3 hr, n=20, 210.03780—
3 hr 30 min, n=20, 210.03922—
3 hr 45 min, n=20, 210.03893—
4 hr 15 min, n=20, 210.04094—
4 hr 30 min, n=20, 210.04000—
4 hr 45 min, n=20, 210.03958—
5 hr, n=20, 210.03814—
5 hr 15 min, n=20, 210.03780—
5 hr 30 min, n=20, 210.03780—
Ratio0.99395% CI0.946 – 1.043p0.791ANOVA
Ratio1.00095% CI0.952 – 1.050p>0.999ANOVA
Ratio1.00195% CI0.953 – 1.051p0.975ANOVA
Ratio1.00095% CI0.952 – 1.050p>0.999ANOVA
Ratio1.00395% CI0.955 – 1.053p0.908ANOVA
Ratio1.02595% CI0.977 – 1.077p0.312ANOVA
Ratio1.00895% CI0.960 – 1.058p0.763ANOVA
Ratio1.09595% CI1.043 – 1.150p<0.001ANOVA
Ratio1.04695% CI0.996 – 1.098p0.070ANOVA
Ratio0.97195% CI0.925 – 1.020p0.238ANOVA
Ratio0.97595% CI0.928 – 1.023p0.298ANOVA
Ratio0.99495% CI0.947 – 1.044p0.821ANOVA
Ratio0.99195% CI0.944 – 1.040p0.715ANOVA
Ratio1.00895% CI0.960 – 1.058p0.759ANOVA
Ratio1.00095% CI0.952 – 1.050p>0.999ANOVA
Secondary/protocol endpoint

Insulin Secretion Rate (Measured by Mathematical Analysis of C-peptide Concentrations) During the Glucose Clamp Period

Time frame:Day 4

descriptive

Posted result

GroupValue (mean), Milliunits per hour (mU/hr)95% CI
Albiglutide 50 mg1 hr0.22992—
1 hr 15 min0.32088—
1 hr 45 min0.02309—
2 hr0.14532—
2 hr 45 min0.01411—
3 hr0.03145—
3 hr 30 min-0.02053—
3 hr 45 min0.01197—
4 hr 15 min0.00892—
4 hr 30 min0.01868—
Placebo1 hr0.15487—
1 hr 15 min0.22083—
1 hr 45 min-0.00873—
2 hr0.08063—
2 hr 45 min0.02484—
3 hr0.04148—
3 hr 30 min-0.00507—
3 hr 45 min0.01878—
4 hr 15 min0.01401—
4 hr 30 min0.02254—
Secondary/protocol endpoint

Insulin Values During the Glucose Clamp Period

Time frame:Day 4

descriptive

Posted result

GroupValue (geometric_mean), Picomoles per liter (pmol/L)95% CI
Albiglutide 50 mg0 hr, n=20, 21140.5—
1 hr, n=20, 21297.5—
1 hr 15 min, n=20, 21385.9—
1 hr 45 min, n=20, 21250.6—
2 hr, n=20, 20437.4—
2 hr 45 min, n=20, 21298.3—
3 hr, n=20, 21680.2—
3 hr 30 min, n=20, 21677.1—
3 hr 45 min, n=20, 211000.6—
4 hr 15 min, n=20, 211738.7—
4 hr 30 min, n=20, 211057.8—
4 hr 45 min, n=20, 21203.0—
5 hr, n=20, 21121.7—
5 hr 15 min, n=20, 2199.5—
5 hr 30 min, n=20, 2194.0—
Placebo0 hr, n=20, 21102.4—
1 hr, n=20, 21183.6—
1 hr 15 min, n=20, 21270.9—
1 hr 45 min, n=20, 21207.4—
2 hr, n=20, 20357.3—
2 hr 45 min, n=20, 21191.9—
3 hr, n=20, 21438.7—
3 hr 30 min, n=20, 21488.0—
3 hr 45 min, n=20, 21861.2—
4 hr 15 min, n=20, 21887.9—
4 hr 30 min, n=20, 21758.1—
4 hr 45 min, n=20, 21115.5—
5 hr, n=20, 2175.6—
5 hr 15 min, n=20, 2169.6—
5 hr 30 min, n=20, 2165.1—
Secondary/protocol endpoint

C-peptide Values During the Glucose Clamp Period

Time frame:Day 4

C-peptide AUC

descriptive

Posted result

GroupValue (geometric_mean), Nanomoles per liter (nmol/L)95% CI
Albiglutide 50 mg0 hr, n=20, 211.095—
1 hr, n=20, 211.616—
1 hr 15 min, n=20, 211.630—
1 hr 45 min, n=20, 210.786—
2 hr, n=20, 200.723—
2 hr 45 min, n=20, 210.362—
3 hr, n=20, 210.309—
3 hr 30 min, n=20, 210.152—
3 hr 45 min, n=20, 210.140—
4 hr 15 min, n=20, 210.105—
4 hr 30 min, n=20, 210.100—
4 hr 45 min, n=20, 210.100—
5 hr, n=20, 210.105—
5 hr 15 min, n=20, 210.118—
5 hr 30 min, n=20, 210.141—
Placebo0 hr, n=20, 210.836—
1 hr, n=20, 210.993—
1 hr 15 min, n=20, 211.053—
1 hr 45 min, n=20, 210.517—
2 hr, n=20, 200.484—
2 hr 45 min, n=20, 210.275—
3 hr, n=20, 210.255—
3 hr 30 min, n=20, 210.138—
3 hr 45 min, n=20, 210.128—
4 hr 15 min, n=20, 210.101—
4 hr 30 min, n=20, 210.100—
4 hr 45 min, n=20, 210.100—
5 hr, n=20, 210.103—
5 hr 15 min, n=20, 210.120—
5 hr 30 min, n=20, 210.138—
Secondary/protocol endpoint

Recovery Time of Plasma Glucose Levels to >=3.9 mmol/L (>=70 mg/dL) From the Hypoglycemic Clamp Level of 2.8 Nmol/L (50.4 mg/dL)

Time frame:Day 4

time to event, improvement

Posted result

GroupValue (median), Minutes95% CI
Albiglutide 50 mg35.0030.00 – 45.00
Placebo30.0025.00 – 40.00

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Norepinephrine Values During the Glucose Clamp Period

Time frame:Day 4

concentration, descriptive

Posted result

GroupValue (geometric_mean), Nanograms per liter (ng/L)95% CI
Albiglutide 50 mg0 hr, n=20, 21340.6—
1 hr, n=20, 21347.1—
1 hr 15 min, n=19, 21382.3—
1 hr 45 min, n=20, 21347.7—
2 hr, n=20, 20346.3—
2 hr 45 min, n=20, 21425.5—
3 hr, n=20, 21425.0—
3 hr 30 min, n=20, 21543.2—
3 hr 45 min, n=20, 21537.5—
4 hr 15 min, n=20, 21624.0—
4 hr 30 min, n=20, 21649.5—
4 hr 45 min, n=20, 21605.0—
5 hr , n=20, 21508.4—
5 hr 15 min, n=20, 21511.3—
5 hr 30 min, n=20, 21469.4—
Placebo0 hr, n=20, 21357.0—
1 hr, n=20, 21360.9—
1 hr 15 min, n=19, 21376.2—
1 hr 45 min, n=20, 21424.6—
2 hr, n=20, 20382.5—
2 hr 45 min, n=20, 21421.2—
3 hr, n=20, 21411.9—
3 hr 30 min, n=20, 21519.2—
3 hr 45 min, n=20, 21447.5—
4 hr 15 min, n=20, 21618.0—
4 hr 30 min, n=20, 21622.2—
4 hr 45 min, n=20, 21605.8—
5 hr , n=20, 21485.4—
5 hr 15 min, n=20, 21464.4—
5 hr 30 min, n=20, 21444.7—
Secondary/protocol endpoint

Growth Hormone Values During the Glucose Clamp Period

Time frame:Day 4

concentration, descriptive

Posted result

GroupValue (geometric_mean), Micrograms per liter (µg/L)95% CI
Albiglutide 50 mg0 hr, n=20, 210.29—
1 hr, n=20, 210.17—
1 hr 15 min, n=20, 210.16—
1 hr 45 min, n=20, 210.34—
2 hr, n=20, 200.60—
2 hr 45 min, n=20, 212.44—
3 hr, n=20, 213.16—
3 hr 30 min, n=20, 214.83—
3 hr 45 min, n=20, 214.36—
4 hr 15 min, n=20, 213.59—
4 hr 30 min, n=20, 213.39—
4 hr 45 min, n=20, 213.41—
5 hr, n=20, 212.55—
5 hr 15 min, n=20, 211.77—
5 hr 30 min, n=20, 211.07—
Placebo0 hr, n=20, 210.26—
1 hr, n=20, 210.23—
1 hr 15 min, n=20, 210.26—
1 hr 45 min, n=20, 210.41—
2 hr, n=20, 200.59—
2 hr 45 min, n=20, 212.25—
3 hr, n=20, 213.50—
3 hr 30 min, n=20, 214.81—
3 hr 45 min, n=20, 214.61—
4 hr 15 min, n=20, 214.34—
4 hr 30 min, n=20, 214.16—
4 hr 45 min, n=20, 213.93—
5 hr, n=20, 212.99—
5 hr 15 min, n=20, 211.93—
5 hr 30 min, n=20, 211.14—
Secondary/protocol endpoint

Cortisol Values During the Glucose Clamp Period

Time frame:Day 4

cortisol counterregulatory

concentration, descriptive

Posted result

GroupValue (geometric_mean), Nanomoles per liter (nmol/L)95% CI
Albiglutide 50 mg0 hr, n=20, 21260.9—
1 hr, n=20, 21208.9—
1 hr 15 min, n=20, 21207.4—
1 hr 45 min, n=20, 21233.2—
2 hr, n=20, 20231.0—
2 hr 45 min, n=20, 21273.9—
3 hr, n=20, 21392.1—
3 hr 30 min, n=20, 21597.0—
3 hr 45 min, n=20, 21667.7—
4 hr 15 min, n=20, 21746.4—
4 hr 30 min, n=20, 21758.2—
4 hr 45 min, n=20, 21780.0—
5 hr, n=20, 21718.9—
5 hr 15 min, n=20, 21703.4—
5 hr 30 min, n=20, 21646.4—
Placebo0 hr, n=20, 21282.9—
1 hr, n=20, 21250.5—
1 hr 15 min, n=20, 21272.3—
1 hr 45 min, n=20, 21230.2—
2 hr, n=20, 20230.7—
2 hr 45 min, n=20, 21290.4—
3 hr, n=20, 21344.0—
3 hr 30 min, n=20, 21534.7—
3 hr 45 min, n=20, 21583.0—
4 hr 15 min, n=20, 21674.0—
4 hr 30 min, n=20, 21705.2—
4 hr 45 min, n=20, 21712.0—
5 hr, n=20, 21673.3—
5 hr 15 min, n=20, 21626.8—
5 hr 30 min, n=20, 21569.0—

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Epinephrine Values During the Glucose Clamp Period

Time frame:Day 4

concentration, descriptive

Posted result

GroupValue (geometric_mean), Nanograms per liter (ng/L)95% CI
Albiglutide 50 mg0 hr, n=19, 2056.9—
1 hr, n=19, 1860.7—
1 hr 15 min, n=18, 1957.8—
1 hr 45 min, n=20, 2169.1—
2 hr, n=20, 2073.2—
2 hr 45 min, n=20, 21183.9—
3 hr, n=19, 21187.1—
3 hr 30 min, n=19, 21429.2—
3 hr 45 min, n=20, 21410.3—
4 hr 15 min, n=20, 21568.3—
4 hr 30 min, n=20, 21608.7—
4 hr 45 min, n=20, 21477.1—
5 hr, n=20, 21246.6—
5 hr 15 min, n=20, 21172.4—
5 hr 30 min, n=20, 21132.5—
Placebo0 hr, n=19, 2059.4—
1 hr, n=19, 1861.2—
1 hr 15 min, n=18, 1959.9—
1 hr 45 min, n=20, 2170.1—
2 hr, n=20, 2081.5—
2 hr 45 min, n=20, 21159.2—
3 hr, n=19, 21171.1—
3 hr 30 min, n=19, 21372.3—
3 hr 45 min, n=20, 21318.8—
4 hr 15 min, n=20, 21519.5—
4 hr 30 min, n=20, 21505.6—
4 hr 45 min, n=20, 21395.4—
5 hr, n=20, 21225.9—
5 hr 15 min, n=20, 21154.4—
5 hr 30 min, n=20, 21118.2—
Secondary/protocol endpoint

Average Albiglutide Concentration on the Day of the Clamp Procedure

Time frame:Day 4

Plasma concentration (steady state)

concentration, descriptive

Posted result

GroupValue (mean), Nanograms per milliliter (ng/mL)95% CI
Albiglutide 50 mgWeek 1, Day 4, 0 hours2110.5—
Week 1, Day 4, 4 hours 45 minutes1968.7—
Average Concentration2039.63—
Secondary/protocol endpoint

Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) and Treatment-emergent Non-serious Adverse Event (AE) During the Clamp Period

Time frame:From the time the participant consented to participate in the study through the end of the study, or the final follow-up visit for participants who discontinued active participation in the study (up to 8 study weeks)

Serious AEs (any)

event count, event

componentsSerious AEs (any), Treatment-emergent AEs (any)

Posted result

GroupValue (number), Participants95% CI
Albiglutide 50 mgAny treatment-emergent non-serious AE9—
Any treatment-emergent SAE0—
PlaceboAny treatment-emergent non-serious AE10—
Any treatment-emergent SAE0—

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

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.