Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Austin, Texas


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.


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 is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:

19 Years

Maximum Age:

70 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:


Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Limited regulatory value to uncontrolled tri

Study Type:


Study Design:

Allocation: Non-Randomized, Endpoint Classificati

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Barbara Troupin, MD, MBA
Study Director

Study Dates

Start Date:August 2008
Completion Date:June 2009
Completion Type:Actual
Primary Completion Date:March 2009
Primary Completion Type:Actual
Verification Date:November 2009
Last Changed Date:November 30, 2009
First Received Date:August 17, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:The change in other glycemic indicators
Time Frame:58 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Demonstrate long term improvement in glycemic control as measured by HgbA1c
Time Frame:58 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Description:Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:VIVUS, Inc.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Synteract, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

This study is not currently recruiting Study Participants. The form below is not enabled.