New guideline of the European Medicines Agency (EMA) on the clinical investigation of medicinal products in the treatment and prevention of diabetes mellitus

Bart Van der Schueren; Patrick Vrijlandt; Andrew Thomson; Heidi Janssen; Kristina Dunder

doi:10.1007/s00125-024-06162-z

New guideline of the European Medicines Agency (EMA) on the clinical investigation of medicinal products in the treatment and prevention of diabetes mellitus

Diabetologia. 2024 Jul;67(7):1159-1162. doi: 10.1007/s00125-024-06162-z. Epub 2024 May 4.

Authors

Bart Van der Schueren^{1

2

3}, Patrick Vrijlandt^{4

5}, Andrew Thomson⁶, Heidi Janssen⁷, Kristina Dunder⁸

Affiliations

¹ Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium. [email protected].
² Laboratory of Clinical and Experimental Endocrinology, University of Leuven, Leuven, Belgium. [email protected].
³ Office of Therapies for Endocrine and Cardiovascular Diseases, European Medicines Agency, Amsterdam, the Netherlands. [email protected].
⁴ Dutch Medicines Evaluation Board, Utrecht, the Netherlands.
⁵ Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
⁶ Data, Analytics and Methodology Taskforce, European Medicines Agency, Amsterdam, the Netherlands.
⁷ Office of Therapies for Endocrine and Cardiovascular Diseases, European Medicines Agency, Amsterdam, the Netherlands.
⁸ Medical Products Agency, Uppsala, Sweden.

PMID: 38702529
DOI: 10.1007/s00125-024-06162-z

No abstract available

Keywords: Cardiovascular disease; Clinical development programme; EU Regulatory Requirements; Glucose-lowering therapy; Prevention of diabetes; Regulatory guidelines; Treatment of diabetes; Type 1 diabetes; Type 2 diabetes.

Publication types

Editorial

MeSH terms

Diabetes Mellitus* / drug therapy
Diabetes Mellitus* / prevention & control
Europe
Humans
Hypoglycemic Agents / therapeutic use

Substances

Hypoglycemic Agents