Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes
NCT ID: NCT00111540
Last Updated: 2015-02-23
Study Results
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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COMPLETED
PHASE3
456 participants
INTERVENTIONAL
2002-11-30
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Exenatide
Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination
exenatide
subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination
Interventions
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exenatide
subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The subject has a body mass index (BMI) of 25 kg/m\^2 to 45 kg/m\^2, inclusive
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Porter, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Birmingham, Alabama, United States
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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
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Aurora, Colorado, United States
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Denver, Colorado, United States
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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
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Blairsville, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Lexington, Kentucky, United States
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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
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Detroit, Michigan, United States
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Edina, Minnesota, United States
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Minneapolis, Minnesota, United States
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Gulfport, Mississippi, United States
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Picayune, Mississippi, United States
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Chesterfield, Missouri, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Las Vegas, Nevada, United States
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New York, New York, United States
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Rochester, New York, United States
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Cary, North Carolina, United States
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Durham, North Carolina, United States
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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
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Clinton, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Camp Hill, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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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
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Salt Lake City, Utah, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
Countries
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References
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Blonde L, Klein EJ, Han J, Zhang B, Mac SM, Poon TH, Taylor KL, Trautmann ME, Kim DD, Kendall DM. Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes. Diabetes Obes Metab. 2006 Jul;8(4):436-47. doi: 10.1111/j.1463-1326.2006.00602.x.
Buse JB, Klonoff DC, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Maggs DG, Wintle ME. Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials. Clin Ther. 2007 Jan;29(1):139-53. doi: 10.1016/j.clinthera.2007.01.015.
Klonoff DC, Buse JB, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Wintle ME, Maggs DG. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008 Jan;24(1):275-86. doi: 10.1185/030079908x253870.
Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26. doi: 10.1089/dia.2006.0024.
Other Identifiers
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2993-119
Identifier Type: -
Identifier Source: org_study_id
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