A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
NCT ID: NCT00500370
Last Updated: 2015-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
163 participants
INTERVENTIONAL
2007-06-30
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A
exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Group B
placebo
subcutaneous injection (equivalent volume to active dose), twice a day
Interventions
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exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
placebo
subcutaneous injection (equivalent volume to active dose), twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)
* Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for \> 3 months
* Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening
* Used drugs for weight loss (e.g., Xenical \[orlistat\], Meridia \[sibutramine\], Acutrim \[phenylpropanolamine\], Accomplia \[rimonabant\], Alli \[low-dose orlistat\], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
* Are actively participating in, or have participated in a formal weight loss program within the last 3 months
* Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics
* Have been treated with any anti-diabetic medications within 3 months of screening
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start
* Have had bariatric surgery
* Have had an organ transplant
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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James Malone, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Research Site
Peoria, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Santa Ana, California, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Topeka, Kansas, United States
Research Site
Wichita, Kansas, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
St Louis, Missouri, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Goose Creek, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Renton, Washington, United States
Research Site
Ponce, , Puerto Rico
Research Site
San Juan, , Puerto Rico
Countries
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References
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Rosenstock J, Klaff LJ, Schwartz S, Northrup J, Holcombe JH, Wilhelm K, Trautmann M. Effects of exenatide and lifestyle modification on body weight and glucose tolerance in obese subjects with and without pre-diabetes. Diabetes Care. 2010 Jun;33(6):1173-5. doi: 10.2337/dc09-1203. Epub 2010 Mar 23.
Other Identifiers
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H8O-MC-GWBP
Identifier Type: -
Identifier Source: org_study_id
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