A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.

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

Details

• Lead Sponsor: VIVUS, Inc.
• Collaborators: Sentrx; Synteract, Inc.
• Treatments: Phentermine; Topiramate

Criteria

Inclusion Criteria:

• Have completed the qualifying OB-202 trial

• If females of child-bearing potential, subjects must be using adequate contraception

• Provide written informed consent

• Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures

Exclusion Criteria:

• Subjects who have developed one or more morbidities during the OB-202 trial that would pose a safety concern