Trial · NCT00486291

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

NCT00486291, Phase 2, Completed, VIVUS LLC; results first posted 2012-09-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics. Trials, record NCT00486291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00486291

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics
NCT number: NCT00486291
Status: Completed
Phases: Phase 2
Enrollment: 210 participants, actual
Lead sponsor: VIVUS LLC
Conditions: Type 2 Diabetes Mellitus
Interventions: VI-0521, Placebo
First posted: 2007-06-14
Last updated: 2012-09-10
Results first posted: 2012-09-03

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in HbA1c at Week 28.	Baseline to 28 weeks
Secondary	Absolute Weight Change (kg) From Baseline to Week 28	Baseline to 28 weeks

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in HbA1c at Week 28.	Baseline to 28 weeks	Intent-to-treat Last-observation-carried-forward (ITT-LOCF)	percent change	LEAST_SQUARES_MEAN
SECONDARY	Absolute Weight Change (kg) From Baseline to Week 28	Baseline to 28 weeks	Intent-to-treat Last-observation-carried-forward (ITT-LOCF)	kg	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in HbA1c at Week 28.	Active	-1.1	Standard Error 0.12	percent change
Change From Baseline in HbA1c at Week 28.	Placebo	-0.6	Standard Error 0.11	percent change
Absolute Weight Change (kg) From Baseline to Week 28	Active	-7.7	Standard Error 0.57	kg
Absolute Weight Change (kg) From Baseline to Week 28	Placebo	-1.3	Standard Error 0.57	kg

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active	105
Overall Study	STARTED	Placebo	105
Overall Study	COMPLETED	Active	89
Overall Study	COMPLETED	Placebo	76
Overall Study	NOT COMPLETED	Active	16
Overall Study	NOT COMPLETED	Placebo	29

Source ClinicalTrials.gov

Adverse events66

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	upper respiratory tract infection	Infections and infestations	Active	13	102
other	upper respiratory tract infection	Infections and infestations	Placebo	19	104
other	influenza	Infections and infestations	Active	8	102
other	influenza	Infections and infestations	Placebo	3	104
other	nasopharyngitis	Infections and infestations	Active	5	102
other	nasopharyngitis	Infections and infestations	Placebo	5	104
other	bronchitis	Infections and infestations	Active	5	102
other	bronchitis	Infections and infestations	Placebo	3	104
other	nausea	Gastrointestinal disorders	Active	18	102
other	nausea	Gastrointestinal disorders	Placebo	5	104

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active
Total, all-cause mortality	Placebo
Total, other adverse events	Active	85	102
Total, other adverse events	Placebo	86	104
Total, serious adverse events	Active	5	102
Total, serious adverse events	Placebo	6	104

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Active vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00486291

GET https://conductscience.org/api/trials/v1/NCT00486291/events?page=2

API reference For AI assistants