Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults
Stopped early · Phase 2
Conditions studied: Diabetes
In brief
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.
Key facts
- Study ID
- NCT00737633
- Run by
- VIVUS LLC
- People needed
- 101
- Starts
- 2008-08-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2012-09-10
Who can join
Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Subjects who have developed one or more morbidities during the DM-230 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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