Long term double blind comparison of gliclazide modified release and an oral anti-diabetic given in combination with metformin in type two diabetic patients: a two year international, multicentre, randomised, double-blind, parallel-group study followed by a two year double blind extension

ISRCTN	ISRCTN67790431
DOI	https://doi.org/10.1186/ISRCTN67790431
EudraCT/CTIS number	2006-001240-30
Secondary identifying numbers	CL3-05702-013

Submission date: 17/11/2006
Registration date: 06/12/2006
Last edited: 06/11/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Stefano Del Prato
Scientific

Department of Endocrinology and Metabolism
Section Diabetes
Ospedale Cisanello
Via Paradisa 2
Pisa
56124
Italy

Study information

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
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	ENDORSE
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	12/03/2008
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	2500
Key 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
Key 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
Date of first enrolment	06/11/2006
Date of final enrolment	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

Institut de Recherches Internationales Servier (France)
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 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.
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

Editorial Notes

06/11/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2011 to 04/12/2007.
2. The overall trial end date was changed from 31/12/2011 to 12/03/2008.
18/04/2018: 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.