Clinical Trial Details
| Trial ID: | L2450 |
| Source ID: | NCT00486291 |
| Associated Drug: | Vi-0521 |
| Title: | Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00486291/results |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: VI-0521|DRUG: Placebo |
| Outcome Measures: | Primary: Change From Baseline in HbA1c at Week 28., Baseline to 28 weeks | Secondary: Absolute Weight Change (kg) From Baseline to Week 28, Baseline to 28 weeks |
| Sponsor/Collaborators: | Sponsor: VIVUS LLC | Collaborators: Synteract, Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 210 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2007-06 |
| Completion Date: | 2008-04 |
| Results First Posted: | 2012-09-03 |
| Last Update Posted: | 2012-09-10 |
| Locations: | Research Site, Birmingham, Alabama, United States|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|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 |
| URL: | https://clinicaltrials.gov/show/NCT00486291 |
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