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Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics

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ClinicalTrials.gov Identifier: NCT00486291
Recruitment Status : Completed
First Posted : June 14, 2007
Results First Posted : September 3, 2012
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
Synteract, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: VI-0521 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Phentermine 15mg/topiramate 100mg
Drug: VI-0521
phentermine 15mg/topiramate 100mg

Placebo Comparator: 2
Matched placebo
Drug: Placebo
matched placebo




Primary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 28. [ Time Frame: Baseline to 28 weeks ]

Secondary Outcome Measures :
  1. Absolute Weight Change (kg) From Baseline to Week 28 [ Time Frame: Baseline to 28 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Type 2 Diabetes
  • BMI 27-42
  • Specified diet/exercise and/or diabetes medications

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486291


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.
Investigators
Study Director: Barbara Troupin, MD, MBA VIVUS, Inc.

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00486291     History of Changes
Other Study ID Numbers: OB-202
First Posted: June 14, 2007    Key Record Dates
Results First Posted: September 3, 2012
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by VIVUS, Inc.:
Diabetes, Obese diabetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases