DiabetesPhase 2NCT00737633

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

A Phase 2 study testing VI-0521 in people with Diabetes, run by VIVUS LLC at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 19 to 70 years
Conditions the study is for: Diabetes
What is being tested?: VI-0521
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 9 sitesUnited States
Study dates: Aug 2008to Jun 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Research Site
Austin, Texas
Research Site
Bethesda, Maryland
Research Site
Birmingham, Alabama
Research Site
Los Angeles, California
Research Site
Richmond, Virginia
Research Site
San Antonio, Texas
Research Site
San Francisco, California
Research Site
Spring Valley, California
Research Site
Walnut Creek, California

Other trials in United States

About this study

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

Conditions: Diabetes
Being tested: VI-0521
Keywords: Diabetes, Type 2 Diabetes, Diabetes Mellitus, Metabolic Diseases, Glucose Metabolism Disorders, Glycemic Control
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2, Metabolic Diseases, Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VI-0521Drug
Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks

Study groups in NCT00737633
Study group	Role	What they receive
16-Week population	Experimental	Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) Receives: Drug: VI-0521
72-Week population	Experimental	Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) Receives: Drug: VI-0521

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c From Baseline to Week 72
Measured: Baseline to 72 weeks

Secondary outcomes (1)

Percent Weight Change From Baseline to Week 72
Measured: Baseline to 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Jun 2009

First posted19 Aug 2008 (estimated)
Study startAug 2008
Primary completionMar 2009
Study completionJun 2009

Why it stopped: Limited regulatory value to uncontrolled trials. No safety/efficacy concerns.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00737633
Sponsor's protocol ID: DM-231
Status last verified: Sep 2012
First submitted: 17 Aug 2008
Last updated: 10 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00737633
Acronym / sponsor ID: DM-231
Conditions: Diabetes
Keywords: Diabetes, Type 2 Diabetes, Diabetes Mellitus, Metabolic Diseases, Glucose Metabolism Disorders, Glycemic Control
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Limited regulatory value to uncontrolled trials. No safety/efficacy concerns.
Enrolment: 101 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Collaborators: Synteract, Inc., Sentrx
Study start: Aug 2008
Primary completion: Mar 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 19 Aug 2008 (estimated)
Results: Posted 3 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
16-Week population	Experimental	Drug: VI-0521Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
72-Week population	Experimental	Drug: VI-0521Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)

Who may qualify

Ages: 19 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VI-0521Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks	Drug	16-Week population, 72-Week population

Primary outcome

Change in HbA1c From Baseline to Week 72
Time frame: Baseline to 72 weeks

1 secondary outcome

Percent Weight Change From Baseline to Week 72
Time frame: Baseline to 72 weeks

Results and safety

Results posted to the registry on 3 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
16-week Population	44	0
72-week Population	57	0

Primary outcome: Change in HbA1c From Baseline to Week 72

Time frame: Baseline to 72 weeks. Mean (Standard Deviation). Unit: percent change

Measure	16-week Population n = 44	72-week Population n = 57
Value	-0.5 (0.79)	-1.4 (1.34)

Population analysed: Intent-to-treat (ITT)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
16-week Population	1 of 44 (2.3%)	33 of 44 (75%)	Not reported
72-week Population	0 of 57 (0%)	34 of 57 (59.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes

Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barbara Troupin, MD, MBA study director

VIVUS LLC

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VI-0521 in people with Diabetes, run by VIVUS LLC at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c From Baseline to Week 72 (time frame: Baseline to 72 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00737633.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.