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| Name | Class |
|---|---|
| Synteract, Inc. | INDUSTRY |
| Sentrx | INDUSTRY |
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The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phentermine/Topiramate | Drug | phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline Week 0 to Week 56 | Baseline to 56 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Loss From Baseline to Week 56 | Baseline to 56 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25249652 | Derived | Garvey WT, Ryan DH, Bohannon NJ, Kushner RF, Rueger M, Dvorak RV, Troupin B. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Diabetes Care. 2014 Dec;37(12):3309-16. doi: 10.2337/dc14-0930. Epub 2014 Sep 23. |
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Subject recruitment occurred in 10 investigative sites in the U.S. between January 2008 and October 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | |
| FG001 | VI-0521 | phentermine 15 mg/topiramate 92 mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | |
| BG001 | Active | PHEN/TPM 15/92 |
| BG002 | Total |
| 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 | HbA1c Change From Baseline Week 0 to Week 56 | Intent-to-treat Last-observation-carried-forward (ITT-LOCF) | Posted | Least Squares Mean | Standard Error | percent change | Baseline to 56 weeks |
|
|
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 | Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| costochondritis | Musculoskeletal and connective tissue 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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| ID | Term |
|---|---|
| C576188 | Qsymia |
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| Placebo | Drug | Oral placebo capsules, once daily, 28 weeks |
|
| 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 |
|
| Lack of Efficacy |
|
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percent Weight Loss From Baseline to Week 56 | Intent-to-treat Last-observation-carried-forward (ITT-LOCF) | Posted | Least Squares Mean | Standard Error | percent change | Baseline to 56 weeks |
|
|
|
|
| 1 |
| 55 |
| 34 |
| 55 |
| EG001 | Active | PHEN/TPM 15/92 | 2 | 75 | 48 | 75 |
| intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| paresthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| diabetes mellitus | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypoesthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue 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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| pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| vision blurred | Eye disorders | MedDRA (10.0) | Systematic Assessment |
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| hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition 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.