RIO-Diabetes: Obese Patients With Type 2 Diabetes

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00029848

Collaborator

(none)

1,045

Enrollment

Locations

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obesity Diabetes Mellitus, Non-Insulin-Dependent Obesity in Diabetes	Drug: Rimonabant (SR141716)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1045 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2001

Actual Primary Completion Date :

May 1, 2004

Actual Study Completion Date :

May 1, 2004

Outcome Measures

Primary Outcome Measures

Change in body weight []

Secondary Outcome Measures

Metabolic parameters []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Innovative Clinical Trials	Birmingham	Alabama	United States	35209
2	Lovelace Scientific Resources	Phoenix	Arizona	United States	85016
3	Advanced Clinicla Therapeutics, LLC	Tucson	Arizona	United States	85712
4	Southern California Prevention and Research Center Inc. (SPARC)	Encino	California	United States	91436
5	Anderson Clinical Research	San Bernardino	California	United States	92408
6	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
7	North East Clinical Research	Hamden	Connecticut	United States	06518
8	Clinical Research of South Florida	Coral Gables	Florida	United States	33134
9	Jackson Downey, MD	Jacksonville	Florida	United States	32205
10	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32205
11	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
12	DMI Helathcare Group	Largo	Florida	United States	33773
13	Orlando Clinical Research Center	Orlando	Florida	United States	32806
14	University Clinical Research	Pembroke Pines	Florida	United States	33024
15	Comprehensive NeuroScience, Inc.	Sarasota	Florida	United States	34232
16	Metabolic Research Institute	West Palm Beach	Florida	United States	33401
17	CSRA Partners in Health, Inc.	Augusta	Georgia	United States	30909
18	nTouch Research	Marietta	Georgia	United States	30066
19	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
20	Physicians Research Group	Indianapolis	Indiana	United States	46250
21	Kansas University Medical Center	Kansas City	Kansas	United States	66160
22	Gulf States Clinical Trails, LLC	Kenner	Louisiana	United States	70062
23	Medical Research Institute	Slidell	Louisiana	United States	70458
24	Androscoggin Cardiology Associates	Auburn	Maine	United States
25	Phase III Clinical Research	Fall River	Massachusetts	United States	02720
26	JM Clinical Trials, Inc.	Swansea	Massachusetts	United States	02777
27	Twin Cities Clinical Research	Arden Hills	Minnesota	United States	55126
28	Lovelace Scientific Resources	Las Vegas	Nevada	United States	89014
29	Endocrinology and Diabetes Consultants, PC	Dover	New Hampshire	United States	03820
30	Radiant Reseach-Moorestown	Moorestown	New Jersey	United States	08057
31	Lovelace Scientific Resources	Albuquerque	New Mexico	United States	87108
32	Physician Clinical Research Service	White Plains	New York	United States	10605
33	Center for Nutrition and Preventive Medicine	Charlotte	North Carolina	United States	28207
34	Radiant Research	Cincinnati	Ohio	United States	45236
35	MFP Research, Inc.	Cincinnati	Ohio	United States	45242
36	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
37	Radiant Research	Portland	Oregon	United States	97201
38	Medical University of South Carolina, Division of Clinical Pharmacology	Charleston	South Carolina	United States	29425
39	Costal Carolina Research Center	Mt. Pleasant	South Carolina	United States	29464
40	TriCities Medical Reseach	Bristol	Tennessee	United States	37620
41	Diabetes $ Glandular Disease Clinic, PA	San Antonio	Texas	United States	78229-4810
42	Endocrine and Diabetes	Ogden	Utah	United States	84403
43	National Clinical Research	Richmond	Virginia	United States	23294
44	Salem Veterans Affairs Medical Center (151)	Salem	Virginia	United States	24153
45	The Chase Wellness Center, Inc.	Virginia Beach	Virginia	United States	23455
46	Sanofi-aventis Administrative Office	Buenos Aires		Argentina
47	Sanofi-aventis Administrative Office	Diegem		Belgium
48	Sanofi-aventis Administrative Office	Laval		Canada
49	Sanofi-aventis Administrative Office	Praha		Czech Republic
50	Sanofi-aventis Administrative Office	Helsinki		Finland
51	Sanofi-aventis Administrative Office	Paris		France
52	Sanofi-aventis Administrative Office	Berlin		Germany
53	Sanofi-aventis Administrative Office	Gouda		Netherlands
54	Sanofi-aventis Administrative office	Warszawa		Poland
55	Sanofi-aventis Administrative Office	Guildford Surrey		United Kingdom