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

February 19, 2015 updated by: AstraZeneca

An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

456

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Bellflower, California, United States
        • Research Site
      • Burlingame, California, United States
        • Research Site
      • Chula Vista, California, United States
        • Research Site
      • Concord, California, United States
        • Research Site
      • Encino, California, United States
        • Research Site
      • Fremont, California, United States
        • Research Site
      • La Jolla, California, United States
        • Research Site
      • Los Gatos, California, United States
        • Research Site
      • Moreno Valley, California, United States
        • Research Site
      • Redwood City, California, United States
        • Research Site
      • San Mateo, California, United States
        • Research Site
      • Walnut Creek, California, United States
        • Research Site
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
      • Denver, Colorado, United States
        • Research Site
    • Florida
      • Gainesville, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Largo, Florida, United States
        • Research Site
      • Maitland, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Ocala, Florida, United States
        • Research Site
    • Georgia
      • Blairsville, Georgia, United States
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Research Site
    • Louisiana
      • Covington, Louisiana, United States
        • Research Site
      • New Orleans, Louisiana, United States
        • Research Site
      • Slidell, Louisiana, United States
        • Research Site
    • Michigan
      • Detroit, Michigan, United States
        • Research Site
    • Minnesota
      • Edina, Minnesota, United States
        • Research Site
      • Minneapolis, Minnesota, United States
        • Research Site
    • Mississippi
      • Gulfport, Mississippi, United States
        • Research Site
      • Picayune, Mississippi, United States
        • Research Site
    • Missouri
      • Chesterfield, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • Montana
      • Butte, Montana, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New York
      • New York, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • North Carolina
      • Cary, North Carolina, United States
        • Research Site
      • Durham, North Carolina, United States
        • Research Site
    • Ohio
      • Columbus, Ohio, United States
        • Research Site
      • Marion, Ohio, United States
        • Research Site
      • Maumee, Ohio, United States
        • Research Site
      • Mentor, Ohio, United States
        • Research Site
    • Oklahoma
      • Clinton, Oklahoma, United States
        • Research Site
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Medford, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Midland, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Washington
      • Olympia, Washington, United States
        • Research Site
      • Spokane, Washington, United States
        • Research Site

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • Is currently treated with certain medications, including exogenous insulin

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exenatide
Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination
Drug: exenatide
subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination
Other Names:
  • Byetta
  • AC2993
  • exendin-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit
Time Frame: 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
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 from Visit 1 to each protocol visit
Time Frame: 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
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 protocol visit
Time Frame: 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
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 protocol visit
Time Frame: 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
Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

Collaborators and Investigators

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

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2002

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

May 23, 2005

First Submitted That Met QC Criteria

May 23, 2005

First Posted (Estimate)

May 24, 2005

Study Record Updates

Last Update Posted (Estimate)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2993-119

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on exenatide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe