In-patient Study in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT00259896

Last Updated: 2012-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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exenatide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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GLP105330

Identifier Type: -

Identifier Source: org_study_id

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