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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00259896

Enrollment

Registered

2005-12-01

Start date

2005-10-31

Completion date

Unknown

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Type 2 Diabetes Mellitus

Keywords

exenatide, pharmacokinetics, pharmacodynamics

Brief summary

This study is a placebo-controlled study in both healthy normal subjects and patients with Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is given for 7 days, and to assess the impact this medication has on various substances in the blood. Assessments include repeat blood sampling and monitoring of any side effects.

Interventions

DRUGexenatide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 66 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacodynamic measurements during 7 days of dosing.	—

Secondary

Measure	Time frame
Pharmacokinetic measurements during 7 days of dosing.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026