CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
Phentermine/Topiramate +1 moredrug
Likely dose
Phentermine/Topiramate 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/NCT00600067
NCT00600067Phase 2Completed
CompareCT.gov

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

VIVUS LLC·interventional·Posted Jan 24, 2008·Updated Sep 10, 2012

In Brief

A Phase 2 clinical trial evaluating Phentermine/Topiramate and Placebo for Diabetes. Completed, enrolled 130 participants across 9 sites.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
CollaboratorsSynteract, Inc., Sentrx

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 24, 2008
Enrollment StartJan 1, 2008
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.4 years ago

Interventions

Phentermine/Topiramatedrug

phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks

Placebodrug

Oral placebo capsules, once daily, 28 weeks