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

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ClinicalTrials.gov Identifier: NCT00600067
Recruitment Status : Completed
First Posted : January 24, 2008
Results First Posted : September 3, 2012
Last Update Posted : September 10, 2012
Sponsor:
Collaborators:
Synteract, Inc.
Sentrx
Information provided by (Responsible Party):
VIVUS, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: Phentermine/Topiramate Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Phentermine/Topiramate
phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
Placebo Comparator: 2 Drug: Placebo
Oral placebo capsules, once daily, 28 weeks



Primary Outcome Measures :
  1. HbA1c Change From Baseline Week 0 to Week 56 [ Time Frame: Baseline to 56 weeks ]

Secondary Outcome Measures :
  1. Percent Weight Loss From Baseline to Week 56 [ Time Frame: Baseline to 56 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600067


Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
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
United States, Maryland
Research Site
Bethesda, Maryland, United States
United States, Texas
Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States
United States, Virginia
Research Site
Richmond, Virginia, United States
Sponsors and Collaborators
VIVUS, Inc.
Synteract, Inc.
Sentrx
Investigators
Study Director: Barbara Troupin, MD, MBA VIVUS, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00600067     History of Changes
Other Study ID Numbers: DM-230
First Posted: January 24, 2008    Key Record Dates
Results First Posted: September 3, 2012
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by VIVUS, Inc.:
Diabetes
Type 2 Diabetes
Diabetes Mellitus
Metabolic Diseases
Glucose Metabolism Disorders
Glycemic Control

Additional relevant MeSH terms:
Topiramate
Phentermine
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Central Nervous System Stimulants
Appetite Depressants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action