Type 2 Diabetes MellitusPhase 2NCT00486291

Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: VI-0521
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 210 participants
Where: 9 sitesUnited States
Study dates: Jun 2007to Apr 2008
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent
Type 2 Diabetes
BMI 27-42
Specified diet/exercise and/or diabetes medications

Who cannot join

BP > 150/95
Stroke/MI/unstable cardiovascular disease within 6 months
Clinically significant renal, hepatic, or psychiatric disease
Unstable thyroid disease or replacement therapy
Nephrolithiasis
Obesity of known genetic or endocrine origin

Show all 12Show fewer

Participation in a formal weight loss program or lifestyle intervention
History of glaucoma
Pregnancy or breastfeeding
Alcohol abuse
Eating disorder
Excluded medications

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: A Phase 2, Randomized, Double Blind, Parallel Design Study Comparing the Efficacy and Safety of VI-0521 to Placebo in the Glycemic Management of Obese Diabetic Adults

The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.

Conditions: Type 2 Diabetes Mellitus
Being tested: VI-0521, Placebo
Keywords: Diabetes, Obese diabetics
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

VI-0521Drug
phentermine 15mg/topiramate 100mg
PlaceboDrug
matched placebo

Study groups in NCT00486291
Study group	Role	What they receive
1	Experimental	Phentermine 15mg/topiramate 100mg Receives: Drug: VI-0521
2	Placebo comparator	Matched placebo Receives: Drug: Placebo

What is being measured

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

Change From Baseline in HbA1c at Week 28.
Measured: Baseline to 28 weeks

Secondary outcomes (1)

Absolute Weight Change (kg) From Baseline to Week 28
Measured: Baseline to 28 weeks

Timeline

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

Jun 2007Apr 2008

First posted14 Jun 2007 (estimated)
Study startJun 2007
Primary completionApr 2008
Study completionApr 2008

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 Type 2 Diabetes MellitusStudies 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00486291
Sponsor's protocol ID: OB-202
Status last verified: Sep 2012
First submitted: 12 Jun 2007
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 Type 2 Diabetes Mellitus 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: A Phase 2, Randomized, Double Blind, Parallel Design Study Comparing the Efficacy and Safety of VI-0521 to Placebo in the Glycemic Management of Obese Diabetic Adults
ClinicalTrials.gov ID: NCT00486291
Acronym / sponsor ID: OB-202
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes, Obese diabetics
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 210 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Collaborators: Synteract, Inc.
Study start: Jun 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 14 Jun 2007 (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.

The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: VI-0521Phentermine 15mg/topiramate 100mg
2	Placebo comparator	Drug: PlaceboMatched placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Informed consent
Type 2 Diabetes
BMI 27-42
Specified diet/exercise and/or diabetes medications

Key exclusion criteria (12 listed)

BP > 150/95
Stroke/MI/unstable cardiovascular disease within 6 months
Clinically significant renal, hepatic, or psychiatric disease
Unstable thyroid disease or replacement therapy
Nephrolithiasis

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 15mg/topiramate 100mg	Drug	1
Placebomatched placebo	Drug	2

Primary outcome

Change From Baseline in HbA1c at Week 28.
Time frame: Baseline to 28 weeks

1 secondary outcome

Absolute Weight Change (kg) From Baseline to Week 28
Time frame: Baseline to 28 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
Active	105	89
Placebo	105	76

Primary outcome: Change From Baseline in HbA1c at Week 28.

Time frame: Baseline to 28 weeks. Least squares mean (Standard Error). Unit: percent change

Measure	Active n = 99	Placebo n = 101
Value	-1.1 (0.12)	-0.6 (0.11)

Active vs Placebo: Mean Difference (Final Values): -0.6 (95% CI -0.9 to -0.2), p = 0.0007, ANCOVA

Population analysed: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)

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
Active	5 of 102 (4.9%)	85 of 102 (83.3%)	Not reported
Placebo	6 of 104 (5.8%)	86 of 104 (82.7%)	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 Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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Not yet recruitingPhase 3
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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 Type 2 Diabetes Mellitus, 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 4 inclusion and 12 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: finished, 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. Some participants in this study may receive a placebo. 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 From Baseline in HbA1c at Week 28. (time frame: Baseline to 28 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 NCT00486291.

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.