Skip to main content
Top
Published in: Diabetologia 7/2024

04-05-2024 | Diabetes Therapy | News

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

Authors: Bart Van der Schueren, Patrick Vrijlandt, Andrew Thomson, Heidi Janssen, Kristina Dunder

Published in: Diabetologia | Issue 7/2024

Login to get access

Excerpt

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]. The guideline is intended to address the current European Union regulatory position on the main topics of importance for the clinical development of new medicinal products in the treatment or prevention of type 1 and type 2 diabetes. One of the main reasons for revising the previous guideline was to update the section on cardiovascular safety, which was addressed in greater detail in the 2016 reflection paper on the assessment of the cardiovascular safety profile of medicinal products [3]. However, the diabetes field has evolved rapidly over the last decade and the revision also presented an opportunity to address other topics that, in the view of EMA or other stakeholders, warranted clarification. …
Literature
14.
go back to reference International Hypoglycaemia Study Group (2017) Glucose concentrations of less than 3.0 mmol/l (54 mg/dl) should be reported in clinical trials: a joint position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 40(1):155–157. https://doi.org/10.2337/dc16-2215CrossRef International Hypoglycaemia Study Group (2017) Glucose concentrations of less than 3.0 mmol/l (54 mg/dl) should be reported in clinical trials: a joint position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 40(1):155–157. https://​doi.​org/​10.​2337/​dc16-2215CrossRef
Metadata
Title
New guideline of the European Medicines Agency (EMA) on the clinical investigation of medicinal products in the treatment and prevention of diabetes mellitus
Authors
Bart Van der Schueren
Patrick Vrijlandt
Andrew Thomson
Heidi Janssen
Kristina Dunder
Publication date
04-05-2024

Other articles of this Issue 7/2024

Diabetologia 7/2024 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine
Webinar | 06-02-2024 | 20:00 (CET)

Mastering chronic pancreatitis pain: A multidisciplinary approach and practical solutions

Severe pain is the most common symptom of chronic pancreatitis. In this webinar, experts share the latest insights in pain management for chronic pancreatitis patients. Experts from a range of disciplines discuss pertinent cases and provide practical suggestions for use within clinical practice.

Sponsored by: Viatris

Developed by: Springer Healthcare