DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT00259896

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

0

Recruiting sites

—

Enrollment

30

Study population

Healthy volunteers, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Pharmacodynamic measurements

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

Study populations

Who this study enrolls

Healthy volunteersType 2 diabetes

Eligibility

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 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.