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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600067
• Other study ID #: DM-230
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2008
• Last updated: September 5, 2012
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: September 2012
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Research Site	Austin	Texas
United States	Research Site	Bethesda	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Los Angeles	California
United States	Research Site	Richmond	Virginia
United States	Research Site	San Antonio	Texas
United States	Research Site	San Francisco	California
United States	Research Site	Spring Valley	California
United States	Research Site	Walnut Creek	California

Sponsors (3)

Lead Sponsor	Collaborator
VIVUS, Inc.	Sentrx, Synteract, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c Change From Baseline Week 0 to Week 56		Baseline to 56 weeks	No
Secondary	Percent Weight Loss From Baseline to Week 56		Baseline to 56 weeks	No