Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults
This study has been terminated.
(Limited regulatory value to uncontrolled trials. No safety/efficacy concerns.)
Sponsor:
VIVUS, Inc.
Collaborators:
Synteract, Inc.
Sentrx
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00737633
First received: August 17, 2008
Last updated: September 5, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes |
Drug: VI-0521 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Non-Randomized Multicenter Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 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:
- Change in HbA1c From Baseline to Week 72 [ Time Frame: Baseline to 72 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent Weight Change From Baseline to Week 72 [ Time Frame: Baseline to 72 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 101 |
| Study Start Date: | August 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 16-Week population
Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
|
Drug: VI-0521
Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks
|
|
Experimental: 72-Week population
Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
|
Drug: VI-0521
Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks
|
Eligibility| Ages Eligible for Study: | 19 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have completed the qualifying DM-230 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
- Be greater than 80% compliant in study medication use during the last three visits for DM-230
Exclusion Criteria:
- Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737633
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: | NCT00737633 History of Changes |
| Other Study ID Numbers: | DM-231 |
| Study First Received: | August 17, 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 |
ClinicalTrials.gov processed this record on May 16, 2013