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 |
| Clinical Trials Information System (CTIS) | 2006-001240-30 |
| Protocol serial number | CL3-05702-013 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
Scientific
Department of Endocrinology and Metabolism
Section Diabetes
Ospedale Cisanello
Via Paradisa 2
Pisa
56124
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double blind parallel group comparative phase III trial. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Gliclazide Modified Release (MR), metformin |
| Primary outcome measure(s) |
Change of HbA1c |
| Key secondary outcome measure(s) |
1. Change of other metabolic parameters (Fasting Plasma Glucose, Insulin, Lipids) |
| Completion date | 12/03/2008 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Australia
- Austria
- Belgium
- Bulgaria
- Canada
- Czech Republic
- France
- Germany
- Hungary
- Italy
- Latvia
- Lithuania
- Netherlands
- Poland
- Portugal
- Romania
- Russian Federation
- Slovakia
- Slovenia
- Spain
Study participating centre
Department of Endocrinology and Metabolism
Pisa
56124
Italy
56124
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
