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

A Phase 2, Randomized, Double Blind, Parallel Design Study Comparing the Efficacy and Safety of VI-0521 to Placebo in the Glycemic Management of Obese Diabetic Adults

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.

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