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

September 5, 2012 updated by: VIVUS LLC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • California
      • Los Angeles, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
      • Spring Valley, California, United States
        • Research Site
      • Walnut Creek, California, United States
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
Oral placebo capsules, once daily, 28 weeks
EXPERIMENTAL: 1
Drug: Phentermine/Topiramate
phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c Change From Baseline Week 0 to Week 56
Time Frame: Baseline to 56 weeks
Baseline to 56 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Weight Loss From Baseline to Week 56
Time Frame: Baseline to 56 weeks
Baseline to 56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVUS LLC

Collaborators

Synteract, Inc.
Sentrx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (ESTIMATE)

January 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM-230

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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