Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.

Key facts

Study ID

NCT00486291

Run by

VIVUS LLC

People needed

210

Starts

2007-06-01

Expected to finish

2008-04-01

Last updated by the study team

2012-09-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent
• Type 2 Diabetes
• BMI 27-42
• Specified diet/exercise and/or diabetes medications

You may not qualify if…

• BP > 150/95
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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