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
English (EN) (405.33 KB - PDF)
Revision 2
Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Revision 2
English (EN) (405.33 KB - PDF)
Overview of comments received on the draft guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus - Revision 2
English (EN) (1008.15 KB - PDF)
Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes - Revision 2
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.
English (EN) (194.38 KB - PDF)
Draft guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Revision 2
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.
English (EN) (263.59 KB - PDF)
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus
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).
English (EN) (92.69 KB - PDF)
Revision 1
Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Revision 1
English (EN) (224.98 KB - PDF)
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)
English (EN) (516.12 KB - PDF)
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)
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.
English (EN) (198.93 KB - PDF)
Draft guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus - Revision 1
English (EN) (254.85 KB - PDF)
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
English (EN) (44.26 KB - PDF)
First version
Note for guidance on clinical investigation of medicinal products in the treatment of Diabetes Mellitus
English (EN) (203.42 KB - PDF)
Related content
- Clinical efficacy and safety: alimentary tract and metabolism
- Directive 2001/83/EC
- Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins - First version
- Clinical development of fixed combination medicinal products
- Evaluation of medicinal products for cardiovascular disease prevention
- ICH E1 Population exposure: the extent of population exposure to assess clinical safety
- ICH E4 Dose response information to support drug registration
- ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data
- ICH E6 (R1) Good clinical practice
- ICH E7 Studies in support of special populations: geriatrics
- ICH E8 General considerations for clinical trials
- ICH E9 Statistical principles for clinical trials
- ICH E10 Choice of control group in clinical trials
- ICH E11 Clinical investigation of medicinal products in the paediatric population
- ICH S7A Safety pharmacology studies for human pharmaceuticals
- ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals
- Investigation of drug interactions
- Need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications
- Pharmacokinetic studies in man
- Need for reproduction studies in the development of insulin analogues
- Non-clinical assessment of the carcinogenic potential of human insulin analogues