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 |
| EudraCT/CTIS number | 2005-004798-60 |
| Secondary identifying numbers | CL3-00780-148 |
- 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
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
| Study design | Double-blind, randomised, parallel group, comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | S00780 (benfluorex), sulfonylurea. |
| Primary outcome measure | Evolution of HbA1c over one year of treatment. |
| Secondary outcome measures | Other efficacy and safety criteria. |
| Overall study start date | 15/01/2006 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
69394
France
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 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? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/10/2012 | Yes | No |
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.
