DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT00354536

CompletedPhase 2

In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus

A Single-blinded Randomized, Placebo-controlled, Staggered-parallel, Escalating-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injections of GSK 716155 in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

5

Recruiting sites

—

Enrollment

60

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Plasma concentration (steady state)

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 IDNCT00354536
Org study IDGLP106073

Timeline

Milestones

Study first posted2006-07-20estimated
Last update posted2016-10-26estimated
Study start2006-02 (month precision)
Primary completion2006-09actual (month precision)
Study completion2006-09actual (month precision)

Assets

Investigational agents

Albiglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months.
•Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea.
•Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study.
•Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg.
•Women must be of non-childbearing potential.

Exclusion criteria

•Laboratory values that meet certain criteria (for example, total cholesterol > 240 mg/dL).
•Clinically significant hepatic enzyme elevation.
•Fasting plasma glucose greater than 240mg/dL.
•Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV.
•Any major illness other than diabetes.
•Previous use of insulin as treatment for diabetes.
•Significant renal disease as defined by screening lab tests.
•History of drug or other allergy, which in the opinion of the investigator contradicts subject participation.
•Smoking or use of nicotine-containing products within the previous 6 months.
•History of alcohol or drug abuse.
•Unwilling to abstain from alcohol during the study.
•Unwilling to abstain from caffeine- or xanthine-containing products during the study.
•Use of St. John's Wort during the study.
•Has donated 500 nL or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
•Previously received any GLP-1 mimetic that has moe than 70% sequence homology to GLP-1.

Endpoints (2)

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

2 endpoints
Primary/protocol endpoint

blood plasma levels of GSK716155

Time frame:on days 2 & 9

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

blood plasma levels of GSK716155

Time frame:on days 2 & 9

Plasma concentration (steady state)

concentration, descriptive

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.