Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults

September 5, 2012 updated by: VIVUS LLC

An Open-Label, Non-Randomized Multicenter Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults

This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

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

19 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have completed the qualifying DM-230 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
  • Be greater than 80% compliant in study medication use during the last three visits for DM-230

Exclusion Criteria:

  • Subjects who have developed one or more morbidities during the DM-230 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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 16-Week population
Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
Drug: VI-0521
Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks
EXPERIMENTAL: 72-Week population
Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
Drug: VI-0521
Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c From Baseline to Week 72
Time Frame: Baseline to 72 weeks
Baseline to 72 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Weight Change From Baseline to Week 72
Time Frame: Baseline to 72 weeks
Baseline to 72 weeks

Collaborators and Investigators

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

Sponsor

VIVUS LLC

Collaborators

Synteract, Inc.
Sentrx

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

August 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

August 17, 2008

First Submitted That Met QC Criteria

August 18, 2008

First Posted (ESTIMATE)

August 19, 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

Other Study ID Numbers

  • DM-231

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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