Trial · NCT00600067

A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults

NCT00600067, Phase 2, Completed, VIVUS LLC; results first posted 2012-09-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults. Trials, record NCT00600067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00600067

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Trial

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

Title: A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
NCT number: NCT00600067
Status: Completed
Phases: Phase 2
Enrollment: 130 participants, actual
Lead sponsor: VIVUS LLC
Conditions: Diabetes
Interventions: Phentermine/Topiramate, Placebo
First posted: 2008-01-24
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	HbA1c Change From Baseline Week 0 to Week 56	Baseline to 56 weeks
Secondary	Percent Weight Loss From Baseline to Week 56	Baseline to 56 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	HbA1c Change From Baseline Week 0 to Week 56	Baseline to 56 weeks	Intent-to-treat Last-observation-carried-forward (ITT-LOCF)	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Weight Loss From Baseline to Week 56	Baseline to 56 weeks	Intent-to-treat Last-observation-carried-forward (ITT-LOCF)	percent change	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
HbA1c Change From Baseline Week 0 to Week 56	Placebo	-1.2	Standard Error 0.13	percent change
HbA1c Change From Baseline Week 0 to Week 56	VI-0521	-1.56	Standard Error 0.11	percent change
Percent Weight Loss From Baseline to Week 56	Placebo	-2.71	Standard Error 0.95	percent change
Percent Weight Loss From Baseline to Week 56	VI-0521	-9.41	Standard Error 0.81	percent change

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	55
Overall Study	STARTED	VI-0521	75
Overall Study	COMPLETED	Placebo	52
Overall Study	COMPLETED	VI-0521	68
Overall Study	NOT COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	VI-0521	7

Source ClinicalTrials.gov

Adverse events62

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	Placebo	8	55
other	upper respiratory tract infection	Infections and infestations	Active	7	75
other	constipation	Gastrointestinal disorders	Placebo	1	55
other	constipation	Gastrointestinal disorders	Active	4	75
other	paresthesia	Nervous system disorders	Placebo	0	55
other	paresthesia	Nervous system disorders	Active	4	75
other	back pain	Musculoskeletal and connective tissue disorders	Placebo	3	55
other	back pain	Musculoskeletal and connective tissue disorders	Active	3	75
other	hypoglycemia	Metabolism and nutrition disorders	Placebo	5	55
other	hypoglycemia	Metabolism and nutrition disorders	Active	9	75

1 to 10 of 62Source ClinicalTrials.gov

See all 62 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Active
Total, other adverse events	Placebo	34	55
Total, other adverse events	Active	48	75
Total, serious adverse events	Placebo	1	55
Total, serious adverse events	Active	2	75

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25249652	DERIVED

Source PubMed

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/NCT00600067

GET https://conductscience.org/api/trials/v1/NCT00600067/events?page=2

API reference For AI assistants