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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00737633
• Other study ID #: DM-231
• Status: Terminated
• Phase: Phase 2
• First received: August 17, 2008
• Last updated: September 5, 2012
• Start date: August 2008
• Est. completion date: June 2009

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• VI-0521
Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 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	Change in HbA1c From Baseline to Week 72		Baseline to 72 weeks	No
Secondary	Percent Weight Change From Baseline to Week 72		Baseline to 72 weeks	No