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

This 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.

Keywords: Diabetes, drug evaluation, clinical development, treatment, prevention, glucose-lowering agents, insulin, confirmatory studies.

Current version - effective from 01/01/2024

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

Adopted Reference Number: CPMP/EWP/1080/00 Rev.2 Legal effective date: 01/01/2024

Revision 2

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

Adopted Reference Number: CPMP/EWP/1080/00 Rev.2 Legal effective date: 01/01/2024

Overview of comments received on the draft guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus - Revision 2

Reference Number: EMA/279883/2023

Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes - Revision 2

Draft: consultation closed Consultation dates: 20/05/2022 to 31/08/2022 Reference Number: EMA/240473/2022 Summary:

This 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.

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

Draft: consultation closed Consultation dates: 07/02/2018 to 15/08/2018 Reference Number: CPMP/EWP/1080/00 Rev. 2 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.

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus

Draft: consultation closed Consultation dates: 28/07/2016 to 31/10/2016 Reference Number: EMA/317855/2016 Summary:

This concept paper (CP) refers to the need for revision of the Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus (1).

Revision 1

Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Revision 1

Adopted Reference Number: CPMP/EWP/1080/00

Overview of comments received on the guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus (CPMP/EWP/1080/00 Rev. 1)

Reference Number: EMA/444348/2012

Draft guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus (second and final release for public consultation) - Revision 1 (second release)

Draft: consultation closed Consultation dates: 16/09/2011 to 18/11/2011 Reference Number: CPMP/EWP/1080/00 Rev. 1* Summary:

This guideline replaces Note for guidance on Clinical Investigation of Medicinal Products in the Treatment of Diabetes Mellitus CPMP/EWP/1080/00. It is the second and final release for public consultation.

Draft guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus - Revision 1

Draft: consultation closed Consultation dates: 20/01/2010 to 31/07/2010 Reference Number: CPMP/EWP/1080/00

Concept paper on the need for revision of the note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus - Revision 1

Reference Number: EMEA/CHMP/EWP/176348/2008

First version

Note for guidance on clinical investigation of medicinal products in the treatment of Diabetes Mellitus

Adopted Reference Number: CPMP/EWP/1080/00 Legal effective date: 01/11/2002