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

This study has been completed.
Sponsor:
Collaborator:
Synteract, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00486291
First received: June 12, 2007
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: VI-0521
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • Change From Baseline in HbA1c at Week 28. [ Time Frame: Baseline to 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute Weight Change (kg) From Baseline to Week 28 [ Time Frame: Baseline to 28 weeks ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Phentermine 15mg/topiramate 100mg
Drug: VI-0521
phentermine 15mg/topiramate 100mg
Placebo Comparator: 2
Matched placebo
Drug: Placebo
matched placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00486291     History of Changes
Other Study ID Numbers: OB-202
Study First Received: June 12, 2007
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, Obese diabetics

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

ClinicalTrials.gov processed this record on July 28, 2014