drugset / Trial / NCT00486291

Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics

NCT00486291 ↗

Phase 2 Completed 210 enrolled VIVUS LLC Synteract, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.

Timeline

Start
2007-06
Primary completion
2008-04
Completion
2008-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); Active vs Placebo; p = 0.0007; Mean Difference (Final Values) -0.6 (95% CI -0.9 to -0.2); ANCOVA NCT00486291 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Phentermine Small molecule 15 mg —
Subject Topiramate Small molecule 100 mg —