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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT00600067

Run by

VIVUS LLC

People needed

130

Starts

2008-01-01

Expected to finish

2008-11-01

Last updated by the study team

2012-09-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Subjects who have developed one or more morbidities during the OB-202 trial that would pose a safety concern

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Los Angeles, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Spring Valley, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Austin, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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