Clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Scientific guideline

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.

Keywords: Diabetes, drug evaluation, clinical development, treatment, prevention, glucose-lowering agents, insulin, confirmatory studies.