Title
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
Phase
Phase 2Lead Sponsor
VivusStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
DiabetesIntervention/Treatment
phentermine topiramate ...Study Participants
130The 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.
phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
Oral placebo capsules, once daily, 28 weeks
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
| Event Type | Organ System | Event Term | Placebo | Active |
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