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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00111540
First received: May 23, 2005
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: exenatide
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, LLC.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ] [ Designated as safety issue: No ]
    Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination

  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ] [ Designated as safety issue: No ]
    Change in lipids from Visit 1 to each visit up to open-ended study termination


Enrollment: 456
Study Start Date: November 2002
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • exendin-4
  • AC2993

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111540

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

No publications provided by Amylin Pharmaceuticals, LLC.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT00111540     History of Changes
Other Study ID Numbers: 2993-119
Study First Received: May 23, 2005
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:
exenatide
diabetes
Amylin
exendin-4

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013