ObesityPhase 3RIO-DiabetesNCT00029848
Obese Patients With Type 2 Diabetes
A Phase 3 study testing Rimonabant (SR141716) in people with Obesity and Diabetes Mellitus, Non-Insulin-Dependent, run by Sanofi at 55 sites in 11 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Diabetes Mellitus, Non-Insulin-Dependent, Obesity in Diabetes
- What is being tested?
- Rimonabant (SR141716)
- How many people
- 1,045 participants
- Where
- 55 sitesin 11 countries
- Study dates
- Oct 2001to May 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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)
Trial locations and contacts
55 sites in 11 countries.
55 sites in 11 countries
United States45 sites
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108
Twin Cities Clinical Research
Arden Hills, Minnesota, 55126
Androscoggin Cardiology Associates
Auburn, Maine
CSRA Partners in Health, Inc.
Augusta, Georgia, 30909
Innovative Clinical Trials
Birmingham, Alabama, 35209
TriCities Medical Reseach
Bristol, Tennessee, 37620
Medical University of South Carolina, Division of Clinical Pharmacology
Charleston, South Carolina, 29425
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, 28207
Radiant Research
Cincinnati, Ohio, 45236
MFP Research, Inc.
Cincinnati, Ohio, 45242
Clinical Research of South Florida
Coral Gables, Florida, 33134
Endocrinology and Diabetes Consultants, PC
Dover, New Hampshire, 03820
Southern California Prevention and Research Center Inc. (SPARC)
Encino, California, 91436
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Phase III Clinical Research
Fall River, Massachusetts, 02720
North East Clinical Research
Hamden, Connecticut, 06518
Physicians Research Group
Indianapolis, Indiana, 46250
Jackson Downey, MD
Jacksonville, Florida, 32205
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32205
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Kansas University Medical Center
Kansas City, Kansas, 66160
Gulf States Clinical Trails, LLC
Kenner, Louisiana, 70062
DMI Helathcare Group
Largo, Florida, 33773
Lovelace Scientific Resources
Las Vegas, Nevada, 89014
nTouch Research
Marietta, Georgia, 30066
Radiant Reseach-Moorestown
Moorestown, New Jersey, 08057
Costal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Endocrine and Diabetes
Ogden, Utah, 84403
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Orlando Clinical Research Center
Orlando, Florida, 32806
University Clinical Research
Pembroke Pines, Florida, 33024
Lovelace Scientific Resources
Phoenix, Arizona, 85016
Radiant Research
Portland, Oregon, 97201
National Clinical Research
Richmond, Virginia, 23294
Salem Veterans Affairs Medical Center (151)
Salem, Virginia, 24153
Diabetes $ Glandular Disease Clinic, PA
San Antonio, Texas, 78229-4810
Anderson Clinical Research
San Bernardino, California, 92408
Comprehensive NeuroScience, Inc.
Sarasota, Florida, 34232
Medical Research Institute
Slidell, Louisiana, 70458
JM Clinical Trials, Inc.
Swansea, Massachusetts, 02777
Advanced Clinicla Therapeutics, LLC
Tucson, Arizona, 85712
The Chase Wellness Center, Inc.
Virginia Beach, Virginia, 23455
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Metabolic Research Institute
West Palm Beach, Florida, 33401
Physician Clinical Research Service
White Plains, New York, 10605
United Kingdom1 site
Sanofi-aventis Administrative Office
Guildford Surrey
About this study
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
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
- Being tested
- Rimonabant (SR141716)
- Keywords
- Diabetes, Obesity
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimonabant (SR141716)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Secondary outcomes (1)
Metabolic parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2002 (estimated)
- Study startOct 2001
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029848
- Sponsor's protocol ID
- EFC4736
- Acronym
- RIO-Diabetes
- Status last verified
- Apr 2009
- First submitted
- 23 Jan 2002
- Last updated
- 20 Apr 2009
- Results posted
- No
Publications
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.
PubMed 17098084
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00029848
- Acronym / sponsor ID
- RIO-Diabetes / EFC4736
- Keywords
- Diabetes, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,045 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 24 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rimonabant (SR141716) | Drug | – |
Primary outcome
Change in body weight
1 secondary outcome
Metabolic parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2009.
- Results publication: PubMed 17098084Scheen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
55 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant (SR141716) in people with Obesity and Diabetes Mellitus, Non-Insulin-Dependent, run by Sanofi at 55 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Argentina, Belgium, Canada, Czechia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2009.