CompletedPhase 1

In-patient Study in Patients With Type 2 Diabetes Mellitus

A Randomized, Open-label, Placebo-controlled, Repeat-dose Study to Assess the Pharmacokinetics and Pharmacodynamics of 5 Micrograms Exenatide Administered Subcutaneously Twice Daily for 7 Days in Healthy Normal Volunteers and in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

GlaxoSmithKline

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

Study population

Healthy volunteers, Type 2 diabetes

Eligibility highlights

Primary endpoint

•Pharmacodynamic measurements

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 IDNCT00259896

Org study IDGLP105330

Timeline

Milestones

Study first posted2005-12-01estimated

Last update posted2012-06-04estimated

Study start2005-10 (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Healthy volunteersType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age66 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•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

•must be willing to wash-out of these medications for 14 days prior to the start of the study

•must have bloodwork that meets certain criteria (for example, total cholesterol < 240 mg/dL)

Exclusion criteria

•must not have any other major illness other than diabetes

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/low confidence

Pharmacodynamic measurements during 7 days of dosing.

descriptive

Secondary/protocol endpoint

Pharmacokinetic measurements during 7 days of dosing.

descriptive

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.