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

Current effective version

PDF iconRevision 1 - Adopted guideline

Currently under revision - see below

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

In progress

PDF iconDraft guideline


PDF iconConcept paper

Published: 07/02/2018

Deadline for comments: 15/08/2018

Published: 28/07/2016

Revision 1

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline (second release)


PDF iconDraft guideline


PDF iconConcept paper

In operation: 15/11/2012-present


Published: 31/07/2012


Published: 07/10/2011


Published: 10/02/2010

Published: 30/05/2008

First version PDF iconAdopted guideline In operation: 01/12/2002-15/11/2012


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