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Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

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ClinicalTrials.gov Identifier: NCT00553787
Recruitment Status : Completed
First Posted : November 6, 2007
Results First Posted : September 6, 2012
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
VIVUS, Inc.

Tracking Information
First Submitted Date  ICMJE November 3, 2007
First Posted Date  ICMJE November 6, 2007
Results First Submitted Date  ICMJE July 31, 2012
Results First Posted Date  ICMJE September 6, 2012
Last Update Posted Date September 10, 2012
Study Start Date  ICMJE November 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • Percent Weight Loss From Baseline to Week 56 [ Time Frame: Baseline to 56 weeks ]
  • Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF [ Time Frame: Baseline to 56 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2007)
Demonstrate an improvement over placebo in mean percent loss of baseline body weight and percent of subjects with at least 5% weight loss [ Time Frame: 56 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2007)
  • Demonstrate improvements in HgbA1c and other obesity-associated comorbidities [ Time Frame: 56 weeks ]
  • Demonstrate an improvement over placebo in absolute weight loss and reduction in waist circumference [ Time Frame: 56 weeks ]
  • Demonstrate an improvement in quality of life [ Time Frame: 56 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions
Official Title  ICMJE A Phase III Randomized, Double-Blind, Placebo Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions
Brief Summary The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Type 2 Diabetes
Intervention  ICMJE
  • Drug: VI-0521
    phentermine 15 mg and topiramate 92 mg, po once daily
  • Drug: VI-0521
    phentermine 7.5 mg and topiramate 46 mg, po once daily
  • Drug: VI-0521
    placebo
Study Arms  ICMJE
  • Experimental: VI-0521 Top
    high dose experimental treatment
    Intervention: Drug: VI-0521
  • Experimental: VI-0521 Mid
    mid dose experimental treatment
    Intervention: Drug: VI-0521
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: VI-0521
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2009)
2487
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2007)
2500
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed Consent
  • BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
  • 70 years of age or less
  • Have 2 or more of the following obesity-related co-morbid conditions:

    • Systolic blood pressure 140-160 mmHg (130-160 if diabetic);
    • Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);
    • Requirement for 2 or more medications to achieve control (<140/90 mmHg)
  • Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (<200 mg/dL)
  • At lease one of the following metabolic criteria:

    • Fasting blood glucose level > 100 mg/dL
    • Glucose level > 140 mg/dL
    • Diagnosis of type 2 diabetes
  • Waist circumference ≥ 102 cm for men or ≥88 cm for women

Exclusion Criteria:

  • 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
  • Glaucoma or intraocular pressure
  • Pregnancy or breastfeeding
  • Drug or Alcohol abuse
  • Smoking cessation within previous 3 months or plans to quit smoking during study
  • Eating disorders
  • Cholelithiasis within past 6 months
  • Excluded medications
  • Type 1 diabetes or use of any antidiabetic medication other than metformin
  • Previous bariatric surgery
  • Bipolar disorder or psychosis
  • Steroid hormone therapy
  • Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
  • Creatinine clearance < 60 mL/minute
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00553787
Other Study ID Numbers  ICMJE OB-303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VIVUS, Inc.
Study Sponsor  ICMJE VIVUS, Inc.
Collaborators  ICMJE Medpace, Inc.
Investigators  ICMJE
Study Director: Craig Peterson VIVUS, Inc.
Study Chair: Kishore Gadde, MD Duke University
PRS Account VIVUS, Inc.
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP