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TerminatedNCT00737633Updated Sep 10, 2012Results posted

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

A Phase 2 interventional study of VI-0521 in Diabetes, sponsored by VIVUS LLC. Terminated at 9 sites in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-09-10.

Sponsored by VIVUS LLC · Phase 2, Interventional, and Treatment

Why this study was terminated
Limited regulatory value to uncontrolled trials. No safety/efficacy concerns.
Phase
Phase 2
Study type
Interventional
Enrollment
101
Allocation
Non-randomized
Ages
19 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes

Keywords

  • Diabetes
  • Type 2 Diabetes
  • Diabetes Mellitus
  • Metabolic Diseases
  • Glucose Metabolism Disorders
  • Glycemic Control
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 101 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

VIVUS LLC is the lead sponsor of 43 studies on the registry; 2 are open to participants now.

Browse VIVUS LLC studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    16-Week population

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

    Drug: VI-0521

  • Experimental
    72-Week population

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

    Drug: VI-0521

Interventions

  • DrugVI-0521

    Drug pages: Phentermine · Topiramate

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

06

What researchers measure

Primary outcomes

  1. Change in HbA1c From Baseline to Week 72

    Time frame: Baseline to 72 weeks

Secondary outcomes

  1. Percent Weight Change From Baseline to Week 72

    Time frame: Baseline to 72 weeks

07

Results

Posted Sep 3, 2012

Participant flow

This is an extension study to OB-202 (NCT00486291) and DM-230 (NCT00600067)

Participant flow — Overall Study
Milestone16-week Population72-week Population
Started4457
Completed00
Not completed4457
Withdrew: Study terminated by sponsor4455
Withdrew: Lost to follow-up01
Withdrew: Protocol non-compliance01

Outcome measures

PrimaryChange in HbA1c From Baseline to Week 72
Time frame:
Baseline to 72 weeks
Reported as:
Mean · percent change
Change in HbA1c From Baseline to Week 72
percent change16-week Population72-week Population
Change in HbA1c From Baseline to Week 72-0.5 ± 0.79-1.4 ± 1.34
SecondaryPercent Weight Change From Baseline to Week 72
Time frame:
Baseline to 72 weeks
Reported as:
Mean · percent change
Percent Weight Change From Baseline to Week 72
percent change16-week Population72-week Population
Percent Weight Change From Baseline to Week 72-5.7 ± 4.64-10.1 ± 8.7

Adverse events

Collected over AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
16-week Population—1/44 (2.3%)33/44 (75%)
72-week Population—0/57 (0%)34/57 (59.6%)
Most frequent serious events
Most frequent serious events
Event16-week Population72-week Population
Coronary Artery DiseaseCardiac disorders1/440/57
Most frequent other events
Showing 10 of 26
Most frequent other events
Event16-week Population72-week Population
dizzinessNervous system disorders7/440/57
constipationGastrointestinal disorders7/440/57
hypoglycemiaMetabolism and nutrition disorders6/448/57
dysgeusiaNervous system disorders6/440/57
insomniaPsychiatric disorders6/442/57
fatigueGeneral disorders6/441/57
dry mouthGastrointestinal disorders5/441/57
nauseaGastrointestinal disorders4/443/57
upper respiratory tract infectionInfections and infestations3/442/57
headacheNervous system disorders3/441/57

Baseline characteristics

Age Continuous
Age Continuous(years)16-week Population72-week PopulationTotal
Mean50.2 ± 8.649.5 ± 7.049.8 ± 7.7
Sex: Female, Male
Sex: Female, Male(Participants)16-week Population72-week PopulationTotal
Female254873
Male19928
Region of Enrollment
Region of Enrollment(participants)16-week Population72-week PopulationTotal
United States4457101
08

Study locations

9 sites
  • Research Site
    Birmingham, Alabama, United States
  • Research Site
    Los Angeles, California, United States
  • Research Site
    San Francisco, California, United States
  • Research Site
    Spring Valley, California, United States
  • Research Site
    Walnut Creek, California, United States
  • Research Site
    Bethesda, Maryland, United States
  • Research Site
    Austin, Texas, United States
  • Research Site
    San Antonio, Texas, United States
  • Research Site
    Richmond, Virginia, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00737633
Lead sponsor
VIVUS LLC
Collaborators
Synteract, Inc., Sentrx
Responsible party
Sponsor
First posted
Aug 19, 2008
Start date
Aug 2008
Primary completion
Mar 2009
Completion
Jun 2009
Results posted
Sep 3, 2012
Last update
Sep 10, 2012

Study contacts

Barbara Troupin, MD, MBA
study director · VIVUS LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Phentermine · Topiramate

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