CompletedPhase 1

Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers

An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects With Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 25-40•Healthy volunteers

Primary endpoint

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 IDNCT00394030

Org study IDGLP107724

Timeline

Milestones

Study start2006-10-16actual

Study first posted2006-10-31estimated

Primary completion2007-03-20actual

Study completion2007-03-20actual

Last update posted2017-09-11actual

Assets

Investigational agents

Albiglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•They can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. T2DM subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a TZD (thiazolidinedione).

•Subjects must have a BMI between 25 and 40 kg/m² and weigh at least 50kg.

•Women must be of non-childbearing potential.

Exclusion criteria

•Bloodwork that meets certain criteria (for example, total cholesterol > 240 mg/dL)

•Clinically significant hepatic enzyme elevation

•HbA1c less than 6.5 or greater than 10

•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 prior to and during the in-patient clinic stays

•Unwilling to abstain from caffeine- or xanthine-containing products prior to and during the in-patient clinic stays

•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.

Endpoints (0)

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.

No endpoints recorded for this trial.

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.