Clinical trial NCT00029848: Obese Patients With Type 2 Diabetes
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety in Obese Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Diabetes Mellitus, Non-Insulin-Dependent
Obesity in Diabetes
Keywords: Diabetes
Obesity
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2002-01-24
Enrollment: 1045
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: To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes


Eligibility criteria: * BMI must be greater than 27 and less than 40
* Treated Type 2 Diabetes on single therapy treatment for at least 1 year
* Stable weight (variation of less than 5 kg within 3 months prior to screening visit)

Primary outcomes:
measure: Change in body weight
Secondary outcomes:
measure: Metabolic parameters
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Innovative Clinical Trials
state: Alabama
city: Phoenix
country: United States
facility: Lovelace Scientific Resources
state: Arizona
city: Tucson
country: United States
facility: Advanced Clinicla Therapeutics, LLC
state: Arizona
city: Encino
country: United States
facility: Southern California Prevention and Research Center Inc. (SPARC)
state: California
city: San Bernardino
country: United States
facility: Anderson Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Hamden
country: United States
facility: North East Clinical Research
state: Connecticut
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Jacksonville
country: United States
facility: Jackson Downey, MD
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Largo
country: United States
facility: DMI Helathcare Group
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute
state: Florida
city: Augusta
country: United States
facility: CSRA Partners in Health, Inc.
state: Georgia
city: Marietta
country: United States
facility: nTouch Research
state: Georgia
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Physicians Research Group
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Kenner
country: United States
facility: Gulf States Clinical Trails, LLC
state: Louisiana
city: Slidell
country: United States
facility: Medical Research Institute
state: Louisiana
city: Auburn
country: United States
facility: Androscoggin Cardiology Associates
state: Maine
city: Fall River
country: United States
facility: Phase III Clinical Research
state: Massachusetts
city: Swansea
country: United States
facility: JM Clinical Trials, Inc.
state: Massachusetts
city: Arden Hills
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Las Vegas
country: United States
facility: Lovelace Scientific Resources
state: Nevada
city: Dover
country: United States
facility: Endocrinology and Diabetes Consultants, PC
state: New Hampshire
city: Moorestown
country: United States
facility: Radiant Reseach-Moorestown
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources
state: New Mexico
city: White Plains
country: United States
facility: Physician Clinical Research Service
state: New York
city: Charlotte
country: United States
facility: Center for Nutrition and Preventive Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Cincinnati
country: United States
facility: MFP Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Radiant Research
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina, Division of Clinical Pharmacology
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Costal Carolina Research Center
state: South Carolina
city: Bristol
country: United States
facility: TriCities Medical Reseach
state: Tennessee
city: San Antonio
country: United States
facility: Diabetes $ Glandular Disease Clinic, PA
state: Texas
city: Ogden
country: United States
facility: Endocrine and Diabetes
state: Utah
city: Richmond
country: United States
facility: National Clinical Research
state: Virginia
city: Salem
country: United States
facility: Salem Veterans Affairs Medical Center (151)
state: Virginia
city: Virginia Beach
country: United States
facility: The Chase Wellness Center, Inc.
state: Virginia
city: Buenos Aires
country: Argentina
facility: Sanofi-aventis Administrative Office
city: Diegem
country: Belgium
facility: Sanofi-aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-aventis Administrative Office
city: Paris
country: France
facility: Sanofi-aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-aventis Administrative Office
city: Warszawa
country: Poland
facility: Sanofi-aventis Administrative office
city: Guildford Surrey
country: United Kingdom
facility: Sanofi-aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF; RIO-Diabetes Study Group. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006 Nov 11;368(9548):1660-72. doi: 10.1016/S0140-6736(06)69571-8.