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

Phase 2

Terminated

• Conditions: Diabetes
• Interventions: Drug: VI-0521

• Registration Number: NCT00737633
• Lead Sponsor: VIVUS LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-17
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-19
• Primary Completion: 2009-03
• Study Completion: 2009-06
• Disposition First Submitted: 2009-11-30
• Disposition First Submitted QC: 2009-11-30
• Disposition First Posted: 2009-12-02
• Results First Submitted: 2012-07-31
• Results First Submitted QC: 2012-07-31
• Status Verified: 2012-09
• Results First Posted: 2012-09-03
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
16-Week population	VI-0521	Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
72-Week population	VI-0521	Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline to Week 72	Baseline to 72 weeks

Secondary Outcome Measures

Name	Time	Method
Percent Weight Change From Baseline to Week 72	Baseline to 72 weeks

Trial Locations

Locations (1)

Research Site; 🇺🇸 Richmond, Virginia, United States