Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics
NCT ID: NCT00486291
Last Updated: 2012-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
210 participants
INTERVENTIONAL
2007-06-30
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Phentermine 15mg/topiramate 100mg
VI-0521
phentermine 15mg/topiramate 100mg
2
Matched placebo
Placebo
matched placebo
Interventions
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VI-0521
phentermine 15mg/topiramate 100mg
Placebo
matched placebo
Eligibility Criteria
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Inclusion Criteria
* Type 2 Diabetes
* BMI 27-42
* Specified diet/exercise and/or diabetes medications
Exclusion Criteria
* Stroke/MI/unstable cardiovascular disease within 6 months
* Clinically significant renal, hepatic, or psychiatric disease
* Unstable thyroid disease or replacement therapy
* Nephrolithiasis
* Obesity of known genetic or endocrine origin
* Participation in a formal weight loss program or lifestyle intervention
* History of glaucoma
* Pregnancy or breastfeeding
* Alcohol abuse
* Eating disorder
* Excluded medications
18 Years
65 Years
ALL
No
Sponsors
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Synteract, Inc.
INDUSTRY
VIVUS LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara Troupin, MD, MBA
Role: STUDY_DIRECTOR
VIVUS LLC
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
Research Site
Spring Valley, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Bethesda, Maryland, United States
Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Richmond, Virginia, United States
Countries
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Other Identifiers
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OB-202
Identifier Type: -
Identifier Source: org_study_id