EMA Publish Draft Guidelines on Clinical Investigations for Medicinal Products in Diabetes Mellitus

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Diabetes mellitus is a metabolic disorder characterised by the presence of hyperglycaemia due to defective insulin secretion, insulin action or both. The chronic hyperglycaemia of diabetes mellitus is associated with significant long term sequelae, particularly damage, dysfunction and failure of various organs – especially the kidney, eye, nerves, heart and blood vessels.
Type 1 diabetes is the result of pancreatic beta cell destruction and is prone to acute complications, such as ketoacidosis. In type 1 diabetes the main goal is optimal blood glucose control to be achieved by optimal insulin replacement therapy, extensive education and disease self management. Prevention of complications and management of pregnancy are important issues.
Type 2 diabetes is a complex disorder which involves various degrees of decreased beta-cell function, peripheral insulin resistance and abnormal hepatic glucose metabolism. Glucose control in type 2 diabetes deteriorates progressively over time, and, after failure of diet and exercise alone, needs on average a new intervention with glucose-lowering agents every 3-4 years in order to obtain/retain good control. Despite combination therapy and/or insulin treatment, a sizeable proportion of patients remain poorly controlled.
Overweight, hypertension and hyperlipidaemia are often associated with diabetes mellitus and multiple cardiovascular risk factor intervention is a key issue in type 2 diabetes. Therefore, global treatment aims in management of diabetes mellitus cover both lowering of blood glucose to near normal levels and correcting metabolic abnormalities and cardiovascular risk factors including weight management.

Indeed, it has been shown that normalisation or near normalisation of glucose levels (assessed by changes in HbA1c) in patients with type 1 and type 2 diabetes significantly reduces the risk of microvascular complications (retinopathy, nephropathy and neuropathy); the macrovascular risk reduction in patients with type 2 diabetes is less certain.
In children and adolescents, the diagnosis of diabetes type 1 and type 2 is similar to that in adults; however, the discrimination between them may not always be straightforward. Type 1 diabetes is the predominant form in children. Type 2 diabetes has been recently emerging among – mostly obese – children in puberty and may present with ketoacidosis as the first manifestation of the disease; an obese adolescent with hyperglycaemia may have either type 1 or type 2 diabetes. An important feature of type 2 diabetes in overweight/obese adolescents is the higher insulin resistance and faster beta cell destruction rate relative to adults.
Following may help discriminating between type 1 and type 2 diabetes and monogenic or other genetic non insulin-deficient diabetic forms in children and adolescents:

• Disease definitions and methods of diagnosing defined in international treatment guidelines such as ADA recommendations or those of the International Society for Paediatric and Adolescent Diabetes for the diagnosis of diabetes in children and adolescence are based on presence or absence of obesity,
• family history,
• fasting insulin and C-peptide levels,
• auto-antibodies
• age of onset

This document provides guidance on clinical development programmes intended to support the registration of new medicinal products for the treatment, delay in onset or prevention of diabetes mellitus or preservation of beta-cell function in patients with diabetes.
These notes are intended to assist applicants during the development phase. Any deviation from guidelines should be explained and justified in the Clinical Overview.
Insulin delivery systems (including pumps, autoinjectors, prefilled syringes, etc.) are outside the scope of this document. Biosimilar insulins are covered by the Annex to Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues – Guidance on Similar Medicinal Products containing Recombinant Human Insulin CHMP/32775/05.

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