NCT00737633

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

An Open-Label, Non-Randomized Multicenter Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	VI-0521	Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-03-01
• Completion: 2009-06-01
• First posted: 2008-08-19
• Last updated: 2012-09-10
• Results posted: 2012-09-03

Locations

9 sites across 1 country: United States