Additional identifiers
EudraCT number
2005-004798-60
ClinicalTrials.gov number
Protocol/serial number
CL3-00780-148
Study information
Scientific title
A one-year multicentre, international, randomised, double-blind study with comparison of benfluorex versus an oral anti-diabetic in combination with sulfonylurea administered orally for the treatment of type two diabetes
Acronym
Study hypothesis
The aim of this study is to demonstrate the non inferiority of the combination of benfluorex plus sulfonylurea compared to the combination of an oral anti-diabetic plus sulfonylurea on the evolution of Haemoglobin A1c (HbA1c) over one year of treatment.
Please note that as of 29/11/2012, the target number of participants for this trial was updated from 1000 to 847
Ethics approval
First Ethics Committee approval in France obtained on 08/12/2005
Study design
Double-blind, randomised, parallel group, comparative study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes
Intervention
Group one: S00780 (benfluorex), and sulfonylurea
Group two: oral antidiabetic and sulfonylurea
Intervention type
Drug
Phase
Not Specified
Drug names
S00780 (benfluorex), sulfonylurea.
Primary outcome measures
Evolution of HbA1c over one year of treatment.
Secondary outcome measures
Other efficacy and safety criteria.
Overall trial start date
15/01/2006
Overall trial end date
01/02/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female aged between 35 and 80 years
2. Body mass index (BMI) between 25 and 45 kg/m2
3. Treated in monotherapy with sulfonylurea
4. Presenting type 2 diabetes
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
847
Participant exclusion criteria
1. Type 1 diabetes
2. Known latent autoimmune diabetes in adults
Recruitment start date
15/01/2006
Recruitment end date
01/02/2008
Locations
Countries of recruitment
France
Trial participating centre
Hôpital Cardio-vasculaire et Pneumologie Louis Pradel
Lyon Cedex 3
69394
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Current version as of 28/03/2018:
Summary results are published on https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
Previous version as of 24/01/2018:
Publication plan:
All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 2014.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL3-00780-148_synopsis_report.pdf
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22723853
Publication citations
-
Results
Derumeaux G, Ernande L, Serusclat A, Servan E, Bruckert E, Rousset H, Senn S, Van Gaal L, Picandet B, Gavini F, Moulin P, , Echocardiographic evidence for valvular toxicity of benfluorex: a double-blind randomised trial in patients with type 2 diabetes mellitus., PLoS ONE, 2012, 7, 6, e38273, doi: 10.1371/journal.pone.0038273.