A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
This study has been completed.
Sponsor:
VIVUS, Inc.
Collaborators:
Synteract, Inc.
Sentrx
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00600067
First received: January 11, 2008
Last updated: September 5, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes |
Drug: Phentermine/Topiramate Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double Blind Multicenter Study to Evaluate the Long-term Safety and Efficacy of VI-0521 Relative to Placebo in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults |
Resource links provided by NLM:
Further study details as provided by VIVUS, Inc.:
Primary Outcome Measures:
- HbA1c Change From Baseline Week 0 to Week 56 [ Time Frame: Baseline to 56 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent Weight Loss From Baseline to Week 56 [ Time Frame: Baseline to 56 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 130 |
| Study Start Date: | January 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Phentermine/Topiramate
phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
|
| Placebo Comparator: 2 |
Drug: Placebo
Oral placebo capsules, once daily, 28 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have completed the qualifying OB-202 trial
- If females of child-bearing potential, subjects must be using adequate contraception
- Provide written informed consent
- Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures
Exclusion Criteria:
- Subjects who have developed one or more morbidities during the OB-202 trial that would pose a safety concern
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600067
Locations
| United States, Alabama | |
| Research Site | |
| Birmingham, Alabama, United States | |
| United States, California | |
| Research Site | |
| 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 | |
| United States, Maryland | |
| Research Site | |
| Bethesda, Maryland, United States | |
| United States, Texas | |
| Research Site | |
| Austin, Texas, United States | |
| Research Site | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Research Site | |
| Richmond, Virginia, United States | |
Sponsors and Collaborators
VIVUS, Inc.
Synteract, Inc.
Sentrx
Investigators
| Study Director: | Barbara Troupin, MD, MBA | VIVUS, Inc. |
More Information
No publications provided
| Responsible Party: | VIVUS, Inc. |
| ClinicalTrials.gov Identifier: | NCT00600067 History of Changes |
| Other Study ID Numbers: | DM-230 |
| Study First Received: | January 11, 2008 |
| Results First Received: | July 31, 2012 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by VIVUS, Inc.:
|
Diabetes Type 2 Diabetes Diabetes Mellitus |
Metabolic Diseases Glucose Metabolism Disorders Glycemic Control |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Phentermine Topiramate Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Appetite Depressants Anti-Obesity Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anticonvulsants Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013