Phase 2
Completed N=130
A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
Source: ClinicalTrials.gov NCT00600067 ↗Enrolled (actual)
130
Serious AEs
2.3%
Results posted
Sep 2012
Primary outcomePrimary: HbA1c Change From Baseline Week 0 to Week 56 — -1.2; -1.56 percent change — p=0.0381
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline Week 0 to Week 56 |
-1.2; -1.56 | 0.0381 sig |
| SECONDARY Percent Weight Loss From Baseline to Week 56 |
-2.71; -9.41 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00600067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.