In-patient Study in Patients With Type 2 Diabetes Mellitus

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00259896

Collaborator

(none)

Enrollment

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2	Drug: exenatide	Phase 1

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Pharmacodynamic measurements during 7 days of dosing. []

Secondary Outcome Measures

Pharmacokinetic measurements during 7 days of dosing. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 66 Years

Sexes Eligible for Study:

All

Accepts 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)