Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: exenatide

• Registration Number: NCT00111540
• Lead Sponsor: AstraZeneca

Brief Summary

This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-05-23
• Study First Submitted QC: 2005-05-23
• Study First Posted: 2005-05-24
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 456

Inclusion Criteria

• The subject has an HbA1c value <=11.0%
• The subject has a body mass index (BMI) of 25 kg/m^2 to 45 kg/m^2, inclusive

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Exclusion Criteria

• Is currently treated with certain medications, including exogenous insulin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exenatide	exenatide	Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination

Primary Outcome Measures

Name	Time	Method
Change in fasting plasma glucose from Visit 1 to each protocol visit	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)	Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination
Change in lipids from Visit 1 to each protocol visit	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)	Change in lipids from Visit 1 to each visit up to open-ended study termination
Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)	Change in HbA1c from Visit 1 to each visit up to open-ended study termination
Change in body weight from Visit 1 to each protocol visit	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)	Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination

Trial Locations

Locations (1)

Research Site; 🇺🇸 Spokane, Washington, United States