Clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/EWP/1080/00 Rev. 1
Published29/06/2012
Effective from15/11/2012
KeywordsDiabetes, drug evaluation, clinical development, treatment, prevention, glucose-lowering agents, insulin
DescriptionThis document provides guidance on clinical development programmes intended to support the registration of new medicinal products for the treatment of diabetes mellitus. It also addresses the development of products to delay in onset or prevention of diabetes mellitus or preservation of beta-cell function in patients with diabetes.


Document history

Revision 2

Concept paper

 

Published: 28/07/2016

Deadline for comments: 31/10/2016

 

Revision 1 

Current version

Adopted guideline


 

Overview of comments


 

Draft guideline (second release)


 

Draft guideline


 

Concept paper

In operation: 15/11/2012–present


 

Published: 31/07/2012


 

Published: 07/10/2011


 

Published: 10/02/2010

 

Published: 30/05/2008

First versionAdopted guidelineIn operation: 01/12/2002–15/11/2012


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