In-patient Study in Patients With Type 2 Diabetes Mellitus

May 31, 2012 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacodynamic measurements during 7 days of dosing.

Secondary Outcome Measures

Outcome Measure
Pharmacokinetic measurements during 7 days of dosing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria

November 30, 2005

First Posted (Estimate)

December 1, 2005

Study Record Updates

Last Update Posted (Estimate)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLP105330

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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