Expired Study
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Austin, Texas


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.


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


Study is Available At:


Original ID:

DM-231


NCT ID:

NCT00737633


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:

Terminated


Study Phase:

Phase 2


Genders:

Both


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:

VIVUS, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Limited regulatory value to uncontrolled tri


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

101


Enrollment Type:

Actual


Overall Contact Information

Official Name:Barbara Troupin, MD, MBA
Study Director
VIVUS, Inc.

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
Name:Phentermine/Topiramate
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

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