In-patient Study in Patients With Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

• Registration Number: NCT00259896
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-11-30
• Study First Submitted QC: 2005-11-30
• Study First Posted: 2005-12-01
• Status Verified: 2011-01
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

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Exclusion Criteria

• must not have any other major illness other than diabetes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pharmacodynamic measurements during 7 days of dosing.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic measurements during 7 days of dosing.