CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 210 enrolled
Drug / intervention
VI-0521 +1 moredrug
Likely dose
VI-0521 15mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00486291
NCT00486291Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double Blind, Parallel Design Study Comparing the Efficacy and Safety of VI-0521 to Placebo in the Glycemic Management of Obese Diabetic Adults

VIVUS LLC·interventional·Posted Jun 14, 2007·Updated Sep 10, 2012

In Brief

A Phase 2 clinical trial evaluating VI-0521 and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 210 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
CollaboratorsSynteract, Inc.

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 14, 2007
Enrollment StartJun 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.1 years ago

Interventions

VI-0521drug

phentermine 15mg/topiramate 100mg

Placebodrug

matched placebo