This guideline intends to address the current EU regulatory position on the main topics of the clinical development of new medicinal products in the treatment or prevention of diabetes type 1 and type 2. The latest revision refers mainly to an update of the safety section with respect to cardiovascular (CV) safety (referring to the Reflection Paper on assessment of cardiovascular safety profile of medicinal products), but also updated guidance concerning estimands, requirements for monotherapy indications, studies in children, high strength insulin preparations, definitions of hypoglycaemia and
development of oral treatments for patients with type 1 diabetes. In addition, some editorial changes have been implemented…
