Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Demonstrate improvement in glycemic control from baseline relative to placebo as measured by HgbA1c
  • Time Frame: 56 weeks
    Safety Issue?: No

Secondary Measures

• The change in other glycemic indicators from baseline relative to placebo
  • Time Frame: 56 weeks
    Safety Issue?: No
• Demonstrate improvements in associated metabolic, cardiovascular, and anthropometric risk factors from baseline relative to placebo
  • Time Frame: 56 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: VIVUS, Inc.

Overall Clinical Trial Officials and Contacts

Barbara Troupin, MD, MBA Study Director VIVUS, Inc.  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00600067

Study ID Number: DM-230

ClinicalTrials.gov Identifier: NCT00600067

Health Authority: United States: Food and Drug Administration