Clinical trial NCT00553787: Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Type 2 Diabetes
Keywords: Obesity, Type 2 diabetes
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2007-11-06
Enrollment: 2487
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent Weight Loss From Baseline to Week 56
timeFrame: Baseline to 56 weeks
measure: Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF
timeFrame: Baseline to 56 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Ridgefield
country: United States
facility: Research Site
state: Connecticut
city: New York
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Austin
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: VIVUS LLC
name: Craig Peterson
role: STUDY_DIRECTOR
affiliation: Duke University
name: Kishore Gadde, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.