NCT00600067

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

A Randomized, Double Blind Multicenter Study to Evaluate the Long-term Safety and Efficacy of VI-0521 Relative to Placebo in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	Phentermine/Topiramate	phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
DRUG	Placebo	Oral placebo capsules, once daily, 28 weeks

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-01-24
• Last updated: 2012-09-10
• Results posted: 2012-09-03

Locations

9 sites across 1 country: United States