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A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults

NCT00600067 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2012-09-10

Study results available
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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.

Conditions

Interventions

DRUG

Phentermine/Topiramate

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

DRUG

Placebo

Oral placebo capsules, once daily, 28 weeks

Sponsors & Collaborators

  • Synteract, Inc.

    collaborator INDUSTRY

  • Sentrx

    collaborator INDUSTRY

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Barbara Troupin, MD, MBA · VIVUS LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00600067 on ClinicalTrials.gov