World Diabetes Day – Supporting the development of new treatments

Diabetes is one of the most prevalent chronic diseases in Europe. Europe has the highest burden of type?1 diabetes in the world, while type 2 diabetes, a condition linked to socio-economic and demographic factors, is on the rise. By 2045, 1 in 10 Europeans will develop the condition.?

Diabetes touches every part of a patient’s life. It requires close monitoring, lifestyle changes and dedicated care. For people with diabetes, safe and effective medicines are essential, helping to manage blood sugar levels and prevent serious complications.??

The field of diabetes has evolved a lot in the past decade, with many new treatments? being approved, including entirely novel classes of medicines. This led EMA to publish a revision of its guideline for the development of medicines for the prevention and treatment of diabetes this year. The updated guideline addresses the major advances since 2012, particularly in terms of cardiovascular safety and modern treatment needs.?

Some aspects addressed in the revised guideline are:?

- Advances in available treatments?

With more options at hand - from new types of long-lasting insulins, to medicines that go beyond controlling blood sugar - there is a need for more clarity on requirements for managing glucose levels and reducing the risk of hypoglycemia. The new guideline better defines stages of type 1 diabetes, fostering the development of disease-modifying treatments for people living with the condition.?

- Primary endpoints in clinical trials??

The guideline still highlights HbA1C - a key measure of long-term blood sugar control – as the most appropriate endpoint in clinical trials. However, it also states the importance of capturing other outcomes, such as hypoglycemia, and it encourages the use of continuous glucose monitors to track low blood sugar events.??

- Special guidance for studies in children??

Trials in children are usually performed after enough safety and efficacy data is available from adult studies. Performing trials in young children with type 2 diabetes is difficult, and the revision offers guidance for younger age groups.?

- Listening to all stakeholders??

During the review of the guidelines, EMA sought input from developers, academia, healthcare professionals and patients through public consultation to ensure the revision meets the needs of all key actors.?

Finding the right treatment can empower patients to live a healthier life.?

That’s why EMA is committed to ensuring access to safe and effective diabetes medicines for EU patients.?

This article was authored by Heidi Janssen , EMA Head of Endocrine and Cardiovascular Diseases

For more information read some of the scientific articles written by our experts:?

Blind E, Janssen H, Dunder K, de Graeff PA. The European Medicines Agency's approval of new medicines for type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2059-2063. doi: 10.1111/dom.13349. Epub 2018 May 30. PMID: 29740935; PMCID: PMC6667915.?

Van der Schueren, B., Vrijlandt, P., Thomson, A. et al. New guideline of the European Medicines Agency (EMA) on the clinical investigation of medicinal products in the treatment and prevention of diabetes mellitus. Diabetologia 67, 1159–1162 (2024). https://doi.org/10.1007/s00125-024-06162-z??