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CompletedPhase 1

Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus -A Phase I/II Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of GSK716155 in Japanese Subjects With Type 2 Diabetes Mellitus

Lead sponsor

GlaxoSmithKline

Asset

GLP-1 / incretin class catch-all

Listed sites

3

Recruiting sites

-

Actual enrollment

40

Study population

Type 2 diabetes

Eligibility highlights

•BMI 20-70•HbA1c 6.5-10%

Primary endpoint

•Plasma concentration (steady state)

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 IDNCT00530309
Org study IDGLP107865

Timeline

Milestones

Study start2007-08-01actual
Study first posted2007-09-17estimated
Primary completion2008-04-17actual
Study completion2008-04-17actual
Last update posted2017-08-17actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age20 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus diagnosed at least 3 months with FPG level <=240mg/dL and HbA1c between 6.5% and 10% inclusive.
•Must be diet controlled - OR - taking a single oral antidiabetic agent (other than thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to the study.
•Must have a BMI:<=35kg/m2, 20 to 70 years of age inclusive.
•Woman must be of non-childbearing potential.

Exclusion criteria

•Positive test result for either syphilis, HBs antigen, HCV antibody, HIV antigen/antibody, or HTLV-1 antibody.
•Clinically significant hepatic enzyme elevation.
•History of metabolic disease other than T2DM.
•Previous use of insulin as a treatment for diabetes within 3 months.
•History of severe gastrointestinal disease.
•Clinically significant cardiovascular disease.
•Significant renal disease as defined by screening lab test.
•History of drug (including albumin or albumin containing agents) allergy.
•History of alcohol or drug abuse.
•Donation of blood in excess of 400mL within previous 4 months.
•Previously received any GLP-1 mimetic or any other albumin-containing products.

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.

Coverage by outcome category

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Plasma concentrations and PD parameters over time and at the end of study

Time frame:Up to Week 9

Plasma concentration (steady state)

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Other metabolic parameters at the end of study

Time frame:Up to Week 9

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.