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1 sty 2024 · 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.
This guideline replaces ‘Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus' (CPMP/EWP/1080/00 Rev. 1) Keywords. Diabetes, Drug Evaluation, Clinical development, Treatment, Prevention, Glucose-lowering agents, Insulin.
This guideline intends to address the EU regulatory position on the main topics of the clinical development of new medicinal products in the treatment of patients with diabetes. 67 . 1. Introduction (background) Diabetes mellitus is a metabolic disorder characterised by the presence of hyperglycaemia due to
4 maj 2024 · The European Medicines Agency (EMA)’s revised guideline on the clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus took effect on 1 January 2024, replacing the previous guideline from 2012 [1, 2].
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.
4 maj 2024 · Research design and methods: A post hoc analysis of the SWITCH (SWITCH 1: n = 501, type 1 diabetes; SWITCH 2: n = 721, type 2 diabetes) and the Trial Comparing Cardiovascular Safety of Insulin ...
14 sty 2013 · The EMA has published an updated guideline for the clinical investigation of medicines to treat or prevent diabetes mellitus. The guideline informs pharmaceutical companies of the requirements for clinical studies to support marketing authorisation for new medicines.
