Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics
A Phase 2, Randomized, Double Blind, Parallel Design Study Comparing the Efficacy and Safety of VI-0521 to Placebo in the Glycemic Management of Obese Diabetic Adults
1 other identifier
interventional
210
1 country
9
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes-mellitus
Started Jun 2007
Shorter than P25 for phase_2 type-2-diabetes-mellitus
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 12, 2007
CompletedFirst Posted
Study publicly available on registry
June 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
September 3, 2012
CompletedSeptember 10, 2012
September 1, 2012
10 months
June 12, 2007
July 31, 2012
September 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in HbA1c at Week 28.
Baseline to 28 weeks
Secondary Outcomes (1)
Absolute Weight Change (kg) From Baseline to Week 28
Baseline to 28 weeks
Study Arms (2)
1
EXPERIMENTALPhentermine 15mg/topiramate 100mg
2
PLACEBO COMPARATORMatched placebo
Interventions
Eligibility Criteria
You may qualify if:
- Informed consent
- Type 2 Diabetes
- BMI 27-42
- Specified diet/exercise and/or diabetes medications
You may not qualify if:
- BP \> 150/95
- Stroke/MI/unstable cardiovascular disease within 6 months
- Clinically significant renal, hepatic, or psychiatric disease
- Unstable thyroid disease or replacement therapy
- Nephrolithiasis
- Obesity of known genetic or endocrine origin
- Participation in a formal weight loss program or lifestyle intervention
- History of glaucoma
- Pregnancy or breastfeeding
- Alcohol abuse
- Eating disorder
- Excluded medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VIVUS LLClead
- Synteract, Inc.collaborator
Study Sites (9)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wesley W. Day, PhD
- Organization
- Vivus, Inc
Study Officials
- STUDY DIRECTOR
Barbara Troupin, MD, MBA
VIVUS LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2007
First Posted
June 14, 2007
Study Start
June 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
September 10, 2012
Results First Posted
September 3, 2012
Record last verified: 2012-09