Draft guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Revision 2

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Download document Draft guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Revision 2
Reference number CPMP/EWP/1080/00 Rev. 2
Status draft: consultation open
First published 2018-02-07
Last updated 2018-02-07
Consultation start date 2018-02-07
Consultation end date 2018-08-15
Email address for submissions cvswpsecretariat@ema.europa.eu

Summary

Diabetes mellitus is a metabolic disorder characterised by the presence of hyperglycaemia due to defective insulin secretion, insulin action or both. The chronic hyperglycaemia of diabetes mellitus is associated with significant long term sequelae, particularly damage, dysfunction and failure of various organs – especially the kidneys, eyes, nerves, heart and blood vessels.