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

ISRCTN	ISRCTN27354239
DOI	https://doi.org/10.1186/ISRCTN27354239
Clinical Trials Information System (CTIS)	2005-004798-60
Protocol serial number	CL3-00780-148
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 20/06/2006
Registration date: 11/07/2006
Last edited: 17/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Prof Philippe Moulin
Scientific

Hôpital Cardio-vasculaire et Pneumologie Louis Pradel
Service d'Endocrinologie - Unité 11
28 avenue Doyen Lépine
Bron BP Lyon Montchat
Lyon Cedex 3
69394
France

Study information

Primary study design	Interventional
Study design	Double-blind, randomised, parallel group, comparative study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	First Ethics Committee approval in France obtained on 08/12/2005
Health condition(s) or problem(s) studied	Type 2 diabetes
Intervention	Group one: S00780 (benfluorex), and sulfonylurea Group two: oral antidiabetic and sulfonylurea
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	S00780 (benfluorex), sulfonylurea.
Primary outcome measure(s)	Evolution of HbA1c over one year of treatment.
Key secondary outcome measure(s)	Other efficacy and safety criteria.
Completion date	01/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	847
Key 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
Key exclusion criteria	1. Type 1 diabetes 2. Known latent autoimmune diabetes in adults
Date of first enrolment	15/01/2006
Date of final enrolment	01/02/2008

Locations

Countries of recruitment

France

Study participating centre

Hôpital Cardio-vasculaire et Pneumologie Louis Pradel

Lyon Cedex 3
69394
France

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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 2014.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2012		Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/04/2018: Internal review
28/03/2018: The publication and dissemination plan has been changed.
24/01/2018: Publication plan and IPD sharing statement added.
04/12/2017: Results summary added.