Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug.

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

Details

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

Criteria

Inclusion Criteria:

• Have completed the qualifying DM-230 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

• Be greater than 80% compliant in study medication use during the last three visits for DM-230

Exclusion Criteria:

• Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern