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Limited regulatory value to uncontrolled trials. No safety/efficacy concerns.
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| Name | Class |
|---|---|
| Synteract, Inc. | INDUSTRY |
| Sentrx | INDUSTRY |
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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. All subjects eligible to enroll into this study will receive study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 16-Week population | Experimental | Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) |
|
| 72-Week population | Experimental | Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VI-0521 | Drug | Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to Week 72 | Baseline to 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Change From Baseline to Week 72 | Baseline to 72 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Troupin, MD, MBA | VIVUS LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
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This is an extension study to OB-202 (NCT00486291) and DM-230 (NCT00600067)
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| ID | Title | Description |
|---|---|---|
| FG000 | 16-week Population | Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) |
| FG001 | 72-week Population | Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 16-week Population | subjects who were randomized to placebo in previous study |
| BG001 | 72-week Population | subjects who were randomized to active during previous study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in HbA1c From Baseline to Week 72 | Intent-to-treat (ITT) | Posted | Mean | Standard Deviation | percent change | Baseline to 72 weeks |
|
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AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 16-week Population | subjects who were randomized to placebo in previous study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wesley W Day, PhD | Vivus, Inc | 650-934-5200 | day@vivus.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D008659 | Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Los Angeles |
| California |
| United States |
| Research Site | San Francisco | California | United States |
| Research Site | Spring Valley | California | United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | Bethesda | Maryland | United States |
| Research Site | Austin | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| protocol non-compliance |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percent Weight Change From Baseline to Week 72 | Intent-to-treat (ITT) | Posted | Mean | Standard Deviation | percent change | Baseline to 72 weeks |
|
|
|
| 1 |
| 44 |
| 33 |
| 44 |
| EG001 | 72-week Population | subjects who were randomized to active during previous study | 0 | 57 | 34 | 57 |
| gastroenteritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| parasthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| dysgeusia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| gastritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| abdominal distension | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| irritability | General disorders | MedDRA (10.0) | Systematic Assessment |
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| back injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| eye pain | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| lacrimation increased | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| chromatopsia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
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.