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

GlaxoSmithKline0 sites30 target enrollmentOctober 2005

ConditionsType 2 Diabetes Mellitus Diabetes Mellitus, Type 2

Drugsexenatide

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: GlaxoSmithKline
Enrollment: 30
Primary Endpoint: Pharmacodynamic measurements during 7 days of dosing.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

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)