Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions
Information source: VIVUS, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Type 2 Diabetes
Intervention: VI-0521 (Drug); VI-0521 (Drug); VI-0521 (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: VIVUS, Inc. Official(s) and/or principal investigator(s):
Craig Peterson, Study Director, Affiliation: VIVUS, Inc.
Kishore Gadde, MD, Study Chair, Affiliation: Duke University
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Demonstrate an improvement over placebo in mean percent loss of baseline body weight and percent of subjects with at least 5% weight loss
Secondary outcome: Demonstrate improvements in HgbA1c and other obesity-associated comorbiditiesDemonstrate an improvement over placebo in absolute weight loss and reduction in waist circumference Demonstrate an improvement in quality of life
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Research Site, Birmingham, Alabama 35294, United States
Research Site, Ridgefield, Connecticut 06877, United States
Research Site, New York, New York 10025, United States
Research Site, Durham, North Carolina 27710, United States
Research Site, Toledo, Ohio 43623, United States
Research Site, Austin, Texas 78731, United States
Additional Information
Starting date: November 2007
Ending date: April 2009
Last updated: May 2, 2008
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