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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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10 December 2019 |
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Main ID: |
ISRCTN67790431 |
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Date of registration:
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06/12/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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
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Date of first enrolment:
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06/11/2006 |
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Target sample size:
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2500 |
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Recruitment status: |
Stopped |
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URL:
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http://isrctn.com/ISRCTN67790431 |
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Study type:
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Interventional |
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Study design:
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Prospective randomised double blind parallel group comparative phase III trial. (Treatment)
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Phase:
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Phase III
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Countries of recruitment
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Australia
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Austria
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Belgium
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Bulgaria
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Canada
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Czech Republic
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France
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Germany
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Hungary
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Latvia
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Lithuania
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Netherlands
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Poland
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Portugal
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Romania
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Russian Federation
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Slovakia
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Slovenia
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Spain
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Stefano
Del Prato |
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Address:
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Department of Endocrinology and Metabolism
Section Diabetes
Ospedale Cisanello
Via Paradisa 2
56124
Pisa
Italy |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 diabetes
Nutritional, Metabolic, Endocrine
Diabetes mellitus
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Intervention(s)
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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.
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Primary Outcome(s)
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Change of HbA1c
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Secondary Outcome(s)
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1. Change of other metabolic parameters (Fasting Plasma Glucose, Insulin, Lipids)
2. Assessment of the safety and acceptability profile
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Secondary ID(s)
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2006-001240-30
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CL3-05702-013
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Source(s) of Monetary Support
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Institut de Recherches Internationales Servier (France)
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Ethics review
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Status:
Approval date:
Contact:
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
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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12/03/2008 |
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URL:
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