Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/06/2006
Date assigned
11/07/2006
Last edited
08/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Philippe Moulin

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2005-004798-60

ClinicalTrials.gov number

Protocol/serial number

CL3-00780-148

Study information

Scientific title

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

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22723853

Publication citations

  1. 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.

Additional files

Editorial Notes