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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VIVUS, Inc.
• Collaborator: Synteract, Inc.

Criteria

Inclusion Criteria:

• Informed consent

• Type 2 Diabetes

• BMI 27-42

• Specified diet/exercise and/or diabetes medications

Exclusion Criteria:

• 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