A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
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| ClinicalTrials.gov Identifier: NCT00600067 |
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Recruitment Status :
Completed
First Posted : January 24, 2008
Results First Posted : September 3, 2012
Last Update Posted : September 10, 2012
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Sponsor:
VIVUS LLC
Collaborators:
Synteract, Inc.
Sentrx
Information provided by (Responsible Party):
VIVUS LLC
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Diabetes |
| Interventions |
Drug: Phentermine/Topiramate Drug: Placebo |
| Enrollment | 130 |
Participant Flow
| Recruitment Details | Subject recruitment occurred in 10 investigative sites in the U.S. between January 2008 and October 2008 |
| Pre-assignment Details |
| Arm/Group Title | Placebo | VI-0521 |
|---|---|---|
 Arm/Group Description |
[Not Specified] | phentermine 15 mg/topiramate 92 mg |
| Period Title: Overall Study | ||
| Started | 55 | 75 |
| Completed | 52 | 68 |
| Not Completed | 3 | 7 |
| Reason Not Completed | ||
| Adverse Event | 0 | 1 |
| Lost to Follow-up | 2 | 3 |
| protocol non-compliance | 0 | 3 |
| Lack of Efficacy | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo | Active | Total | |
|---|---|---|---|---|
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Arm/Group Description |
[Not Specified] | PHEN/TPM 15/92 | Total of all reporting groups | |
| Overall Number of Baseline Participants | 55 | 75 | 130 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 55 participants | 75 participants | 130 participants | |
| 49.5 (8.58) | 49.7 (7.51) | 49.6 (7.95) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 55 participants | 75 participants | 130 participants | |
| Female |
32 58.2%
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58 77.3%
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90 69.2%
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| Male |
23 41.8%
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17 22.7%
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40 30.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 55 participants | 75 participants | 130 participants |
| 55 | 75 | 130 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution & PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.
Results Point of Contact
| Name/Title: | Wesley W. Day, PhD |
| Organization: | Vivus, Inc |
| Phone: | 650-934-5200 |
| EMail: | day@vivus.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VIVUS LLC |
| ClinicalTrials.gov Identifier: | NCT00600067 |
| Other Study ID Numbers: |
DM-230 |
| First Submitted: | January 11, 2008 |
| First Posted: | January 24, 2008 |
| Results First Submitted: | July 31, 2012 |
| Results First Posted: | September 3, 2012 |
| Last Update Posted: | September 10, 2012 |