Additional identifiers
EudraCT/CTIS number
2006-001240-30
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL3-05702-013
Study information
Scientific title
Long term double blind comparison of gliclazide MR (30 to 120 mg daily per os) and rosiglitazone (4 to 8 mg daily per os) given in combination with metformin in type 2 diabetic patients.A 2-year international, multicentre, randomised, double-blind, parallel-group study followed by a 2-year double blind extension. - ENDORSE
Acronym
ENDORSE
Study hypothesis
To compare the efficacy of the two bi-therapies administered at optimal dosage on mean weighted HbA1c over two years.
Ethics approval(s)
Positive opinion from local ethics committee (Comités de Consultation pour la Protection des Personnes se prêtant à la Recherche Biomédicale [CCPPRB] Hôpital Robert Ballanger, Aulnay sous Bois, France) on 28/07/2006, ref: MCF-22/2006
Study design
Prospective randomised double blind parallel group comparative phase III trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Please note that as of 02/12/10 the status of this trial has been changed to "Stopped".
Following the publication on rosiglitazone cardiovascular safety by Nissen in May 2007 and the European Medicines Agency (EMEA) review in October 2007 on the benefits and risks of rosiglitazone and pioglitazone, the recruitment of the ENDORSE study (gliclazide MR versus rosiglitazone, on top of metformin) became no longer feasible and the study was prematurely stopped (last visit patient on 12 March 2008).
Gliclazide Modified Release (MR) versus an oral anti-diabetic on top of metformin.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase III
Drug/device/biological/vaccine name(s)
Gliclazide Modified Release (MR), metformin
Primary outcome measure
Change of HbA1c
Secondary outcome measures
1. Change of other metabolic parameters (Fasting Plasma Glucose, Insulin, Lipids)
2. Assessment of the safety and acceptability profile
Overall study start date
06/11/2006
Overall study end date
12/03/2008
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. Type 2 diabetic outpatients
2. Male or female aged more than 35 years inclusive
3. Body Mass Index (BMI) 24-38 kg/m^2 inclusive
4. Treated in monotherapy with metformin
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
2500
Participant exclusion criteria
1. Type 1 diabetes
2. Recent major cardiovascular events
3. Uncontrolled and clinically significant diseases
4. Insulin therapy
5. Severe and unstable diabetic complications
Recruitment start date
06/11/2006
Recruitment end date
04/12/2007
Locations
Countries of recruitment
Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, Spain, United Kingdom
Study participating centre
Department of Endocrinology and Metabolism
Pisa
56124
Italy
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
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 in 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.
Intention to publish date
Individual participant data (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.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No |