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

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Current effective version

Revision 1 - Adopted guideline

Currently under revision - see below

Reference numberCHMP/EWP/1080/00 Rev. 1
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

In progress

Draft guideline


Concept paper

Published: 07/02/2018

Deadline for comments: 15/08/2018


Published: 28/07/2016

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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