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Delfa

← All trials/NCT00938158

CompletedPhase 1

A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.

An Adaptive Design Study for the Assessment of the Pharmacokinetics of Albiglutide in Subjects With Normal Renal Function and Subjects With Moderate-to-severe Renal Impairment and Hemodialysis.

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

7

Recruiting sites

-

Actual enrollment

75

Study population

Renal impairment, Type 2 diabetes

Eligibility highlights

•HbA1c 6-10.5%

Primary endpoint

•Primary objective is to characterize the PK of albiglutide

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 IDNCT00938158
Org study ID108370

Timeline

Milestones

Study first posted2009-07-13estimated
Study start2009-08-05actual
Primary completion2011-04-12actual
Study completion2011-04-12actual
Last update posted2017-07-21actual

Assets

Investigational agents

Albiglutide

Who this study enrolls

Renal impairmentType 2 diabetes

Who can enroll

Minimum age30 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•normal renal function or renal impairment
•stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of >200mL/min (cohort 3 only)
•neither pregnant nor lactating
•HbA1c 6-10.5% inclusive
•females of childbearing potential must be practicing adequate contraception.

Exclusion criteria

•inability to meet the PK objectives of the study
•history of hypoglycemia unawareness or severe hypoglycemia
•liver function tests greater than or equal to 2 times the ULN
•clinically significant cardiovascular and/or cerebrovascular disease
•positive test results for hepatitis B, hepatitis C, or HIV
•documented hypertension or hypotension at screening
•known hepatic or biliary abnormalities
•current use of sulfonylureas
•active history of tobacco use within 6 months before screening
•donation of blood in excess of 500mL within 56 days before albiglutide dosing
•receipt of any investigational drug within the 30days or 5 half lives, whichever is longer, before dosing
•previous or current receipt of exenatide or any other GLP-1 agonist

Endpoints (4)

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.

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

The primary objective is to characterize the PK of albiglutide in subjects with type 2 diabetes and varying degrees of renal impairment, including subjects requiring hemodialysis, and in age, gender and BMI-matched subjects.

Time frame:42 days

descriptive

Secondary/protocol endpoint

To assess the PK of albiglutide in subjects with varying degrees of proteinuria

Time frame:42 days

descriptive

Secondary/protocol endpoint

To assess the effects of hemodialysis on the overall PK profile of albiglutide

Time frame:42 days

descriptive

Secondary/protocol endpoint

To assess the safety and tolerability of a single dose of albiglutide in subjects with varying degrees of renal impairment and in age, gender and BMI-matched subjects with normal renal function

Time frame:42 days

descriptive

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 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.