NCT00600067CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- VIVUS LLC
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- HbA1c Change From Baseline Week 0 to Week 56
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- 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
Arms & Interventions
1
Experimental
Intervention: Phentermine/Topiramate (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
HbA1c Change From Baseline Week 0 to Week 56
Time Frame: Baseline to 56 weeks
Secondary Outcomes
- Percent Weight Loss From Baseline to Week 56(Baseline to 56 weeks)
Investigators
Study Sites (1)
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