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

• 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: VIVUS LLC
• Collaborators: Synteract, Inc.; Sentrx
• Information provided by (Responsible Party): VIVUS LLC

Tracking Information

• First Submitted Date: January 11, 2008
• First Posted Date: January 24, 2008
• Results First Submitted Date: July 31, 2012
• Results First Posted Date: September 3, 2012
• Last Update Posted Date: September 10, 2012
• Study Start Date: January 2008
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 5, 2012): HbA1c Change From Baseline Week 0 to Week 56 [ Time Frame: Baseline to 56 weeks ]
• Original Primary Outcome Measures (submitted: January 23, 2008): Demonstrate improvement in glycemic control from baseline relative to placebo as measured by HgbA1c [ Time Frame: 56 weeks ]
• Current Secondary Outcome Measures (submitted: September 5, 2012): Percent Weight Loss From Baseline to Week 56 [ Time Frame: Baseline to 56 weeks ]

Original Secondary Outcome Measures (submitted: January 23, 2008)

• The change in other glycemic indicators from baseline relative to placebo [ Time Frame: 56 weeks ]
• Demonstrate improvements in associated metabolic, cardiovascular, and anthropometric risk factors from baseline relative to placebo [ Time Frame: 56 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Diabetes

Intervention

• Drug: Phentermine/Topiramate
  phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
• Drug: Placebo
  Oral placebo capsules, once daily, 28 weeks

Study Arms

• Experimental: 1
  Intervention: Drug: Phentermine/Topiramate
• Placebo Comparator: 2
  Intervention: Drug: Placebo

• Publications *: Garvey WT, Ryan DH, Bohannon NJ, Kushner RF, Rueger M, Dvorak RV, Troupin B. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Diabetes Care. 2014 Dec;37(12):3309-16. doi: 10.2337/dc14-0930. Epub 2014 Sep 23.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 18, 2009): 130
• Original Estimated Enrollment (submitted: January 23, 2008): 160
• Actual Study Completion Date: November 2008
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00600067
• Other Study ID Numbers: DM-230
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: VIVUS LLC
• Original Responsible Party: Lan Nguyen, Clinical Trial Manager, VIVUS Inc.
• Current Study Sponsor: VIVUS LLC
• Original Study Sponsor: Same as current

Collaborators

• Synteract, Inc.
• Sentrx

Investigators

• Study Director: Barbara Troupin, MD, MBA; VIVUS LLC

• PRS Account: VIVUS LLC
• Verification Date: September 2012