A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
Phase 2
Completed
- Conditions
- Diabetes
- Interventions
- Drug: Phentermine/TopiramateDrug: Placebo
- Registration Number
- NCT00600067
- Lead Sponsor
- VIVUS LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Phentermine/Topiramate - 2 Placebo -
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline Week 0 to Week 56 Baseline to 56 weeks
- Secondary Outcome Measures
Name Time Method Percent Weight Loss From Baseline to Week 56 Baseline to 56 weeks
Trial Locations
- Locations (1)
Research Site
🇺🇸Richmond, Virginia, United States