Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics

September 5, 2012 updated by: VIVUS LLC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Type 2 Diabetes
  • BMI 27-42
  • Specified diet/exercise and/or diabetes medications

Exclusion Criteria:

  • BP > 150/95
  • Stroke/MI/unstable cardiovascular disease within 6 months
  • Clinically significant renal, hepatic, or psychiatric disease
  • Unstable thyroid disease or replacement therapy
  • Nephrolithiasis
  • Obesity of known genetic or endocrine origin
  • Participation in a formal weight loss program or lifestyle intervention
  • History of glaucoma
  • Pregnancy or breastfeeding
  • Alcohol abuse
  • Eating disorder
  • Excluded medications

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Phentermine 15mg/topiramate 100mg
Drug: VI-0521
phentermine 15mg/topiramate 100mg
Placebo Comparator: 2
Matched placebo
Drug: Placebo
matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in HbA1c at Week 28.
Time Frame: Baseline to 28 weeks
Baseline to 28 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute Weight Change (kg) From Baseline to Week 28
Time Frame: Baseline to 28 weeks
Baseline to 28 weeks

Collaborators and Investigators

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

Sponsor

VIVUS LLC

Collaborators

Synteract, Inc.

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

June 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

June 12, 2007

First Submitted That Met QC Criteria

June 12, 2007

First Posted (Estimate)

June 14, 2007

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

  • OB-202

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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