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

This study has been completed.
Sponsor:
Collaborators:
Synteract, Inc.
Sentrx
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00600067
First received: January 11, 2008
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Diabetes
Drug: Phentermine/Topiramate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • HbA1c Change From Baseline Week 0 to Week 56 [ Time Frame: Baseline to 56 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Weight Loss From Baseline to Week 56 [ Time Frame: Baseline to 56 weeks ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00600067     History of Changes
Other Study ID Numbers: DM-230
Study First Received: January 11, 2008
Results First Received: July 31, 2012
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on October 19, 2014