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

Sponsor:	VIVUS, Inc.
Collaborator:	Medpace, Inc.
Information provided by (Responsible Party):	VIVUS, Inc.
ClinicalTrials.gov Identifier:	NCT00553787

Purpose

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.

Condition	Intervention	Phase
Obesity Type 2 Diabetes	Drug: VI-0521	Phase III

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Obesity Weight Control

U.S. FDA Resources

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Demonstrate improvements in HgbA1c and other obesity-associated comorbidities [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Demonstrate an improvement over placebo in absolute weight loss and reduction in waist circumference [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Demonstrate an improvement in quality of life [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Enrollment:	2487
Study Start Date:	November 2007
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VI-0521 Top high dose experimental treatment	Drug: VI-0521 phentermine 15 mg and topiramate 92 mg, po once daily
Experimental: VI-0521 Mid mid dose experimental treatment	Drug: VI-0521 phentermine 7.5 mg and topiramate 46 mg, po once daily
Placebo Comparator: Placebo Placebo	Drug: VI-0521 placebo

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553787

Locations

United States, Alabama
Research Site
Birmingham, Alabama, United States, 35294
United States, Connecticut
Research Site
Ridgefield, Connecticut, United States, 06877
United States, New York
Research Site
New York, New York, United States, 10025
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
United States, Ohio
Research Site
Toledo, Ohio, United States, 43623
United States, Texas
Research Site
Austin, Texas, United States, 78731

Sponsors and Collaborators

VIVUS, Inc.

Medpace, Inc.

Investigators

Study Director:	Craig Peterson	VIVUS, Inc.
Study Chair:	Kishore Gadde, MD	Duke University

More Information

No publications provided by VIVUS, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gadde KM, Allison DB, Ryan DH, Peterson CA, Troupin B, Schwiers ML, Day WW. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Apr 16;377(9774):1341-52. Epub 2011 Apr 8.

Responsible Party:	VIVUS, Inc.
ClinicalTrials.gov Identifier:	NCT00553787 History of Changes
Other Study ID Numbers:	OB-303
Study First Received:	November 3, 2007
Last Updated:	September 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:

Obesity, Type 2 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012