Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions
NCT ID: NCT00553787
Last Updated: 2012-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2487 participants
INTERVENTIONAL
2007-11-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VI-0521 Top
high dose experimental treatment
VI-0521
phentermine 15 mg and topiramate 92 mg, po once daily
VI-0521 Mid
mid dose experimental treatment
VI-0521
phentermine 7.5 mg and topiramate 46 mg, po once daily
Placebo
Placebo
VI-0521
placebo
Interventions
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VI-0521
phentermine 15 mg and topiramate 92 mg, po once daily
VI-0521
phentermine 7.5 mg and topiramate 46 mg, po once daily
VI-0521
placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Medpace, Inc.
INDUSTRY
VIVUS LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Craig Peterson
Role: STUDY_DIRECTOR
VIVUS LLC
Kishore Gadde, MD
Role: STUDY_CHAIR
Duke University
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Ridgefield, Connecticut, United States
Research Site
New York, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Toledo, Ohio, United States
Research Site
Austin, Texas, United States
Countries
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References
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Guo F, Garvey WT. Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes Care. 2017 Jul;40(7):856-862. doi: 10.2337/dc17-0088. Epub 2017 Apr 28.
Garvey WT, Ryan DH, Bohannon NJ, Kushner RF, Rueger M, Dvorak RV, Troupin B. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Diabetes Care. 2014 Dec;37(12):3309-16. doi: 10.2337/dc14-0930. Epub 2014 Sep 23.
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. doi: 10.1016/S0140-6736(11)60205-5. Epub 2011 Apr 8.
Other Identifiers
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OB-303
Identifier Type: -
Identifier Source: org_study_id