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

NCT ID: NCT00737633

Last Updated: 2012-09-10

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Keywords

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Diabetes Type 2 Diabetes Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders Glycemic Control

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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16-Week population

Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)

Group Type EXPERIMENTAL

VI-0521

Intervention Type DRUG

Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks

72-Week population

Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)

Group Type EXPERIMENTAL

VI-0521

Intervention Type DRUG

Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks

Interventions

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VI-0521

Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synteract, Inc.

INDUSTRY

Sponsor Role collaborator

Sentrx

INDUSTRY

Sponsor Role collaborator

VIVUS LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Troupin, MD, MBA

Role: STUDY_DIRECTOR

VIVUS LLC

Locations

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Research Site

Birmingham, Alabama, United States

Site Status

Research Site

Los Angeles, California, United States

Site Status

Research Site

San Francisco, California, United States

Site Status

Research Site

Spring Valley, California, United States

Site Status

Research Site

Walnut Creek, California, United States

Site Status

Research Site

Bethesda, Maryland, United States

Site Status

Research Site

Austin, Texas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Research Site

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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DM-231

Identifier Type: -

Identifier Source: org_study_id