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

This study has been terminated.
(Limited regulatory value to uncontrolled trials. No safety/efficacy concerns.)
Sponsor:
Collaborators:
Synteract, Inc.
Sentrx
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00737633
First received: August 17, 2008
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Drug: VI-0521
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • Change in HbA1c From Baseline to Week 72 [ Time Frame: Baseline to 72 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Weight Change From Baseline to Week 72 [ Time Frame: Baseline to 72 weeks ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00737633

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: NCT00737633     History of Changes
Other Study ID Numbers: DM-231
Study First Received: August 17, 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

ClinicalTrials.gov processed this record on November 23, 2014