Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/11/2006
Date assigned
06/12/2006
Last edited
18/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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 Stefano Del Prato

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2006-001240-30

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

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

Trial setting

Hospitals

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

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

Phase

Phase III

Drug names

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 trial start date

06/11/2006

Overall trial end date

31/12/2011

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

Patient

Age group

Adult

Gender

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

31/12/2011

Locations

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, Spain, United Kingdom

Trial 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

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

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 statement:
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.

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

http://clinicaltrials.servier.com/wp-content/uploads/CL3-05702-013_synopsis_report.pdf

Publication list

Publication citations

Additional files

Editorial Notes

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.