NCT00600067

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2 diabetes

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

September 3, 2012

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

10 months

First QC Date

January 11, 2008

Results QC Date

July 31, 2012

Last Update Submit

September 5, 2012

Conditions

Diabetes

Keywords

DiabetesType 2 DiabetesDiabetes MellitusMetabolic DiseasesGlucose Metabolism DisordersGlycemic Control

Outcome Measures

Primary Outcomes (1)

  • HbA1c Change From Baseline Week 0 to Week 56

    Baseline to 56 weeks

Secondary Outcomes (1)

  • Percent Weight Loss From Baseline to Week 56

    Baseline to 56 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: Phentermine/Topiramate

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Phentermine/TopiramateDRUG

phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks

1
PlaceboDRUG

Oral placebo capsules, once daily, 28 weeks

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects who have developed one or more morbidities during the OB-202 trial that would pose a safety concern

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Birmingham, Alabama, United States

Location

Research Site

Los Angeles, California, United States

Location

Research Site

San Francisco, California, United States

Location

Research Site

Spring Valley, California, United States

Location

Research Site

Walnut Creek, California, United States

Location

Research Site

Bethesda, Maryland, United States

Location

Research Site

Austin, Texas, United States

Location

Research Site

San Antonio, Texas, United States

Location

Research Site

Richmond, Virginia, United States

Location

Related Publications (1)

  • Garvey WT, Ryan DH, Bohannon NJ, Kushner RF, Rueger M, Dvorak RV, Troupin B. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Diabetes Care. 2014 Dec;37(12):3309-16. doi: 10.2337/dc14-0930. Epub 2014 Sep 23.

    PMID: 25249652DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Metabolic DiseasesGlucose Metabolism Disorders

Interventions

Qsymia

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Wesley W. Day, PhD
Organization
Vivus, Inc
day@vivus.com
650-934-5200

Study Officials

  • Barbara Troupin, MD, MBA

    VIVUS LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2008

First Posted

January 24, 2008

Study Start

January 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 10, 2012

Results First Posted

September 3, 2012

Record last verified: 2012-09

Locations

US(9)