The data of the clinical trials conducted in recent years have been published in the journal Nature Reviews Endocrinology

The most effective treatment for type 1 diabetes? A therapy based on a combination of agents that regenerate the ß-cells of the pancreas and immunomodulatory drugs. This is indicated by a study coordinated by Prof. Paolo Pozzilli, Director of the Endocrinology and Diabetology Laboratory at theUniversità Campus Bio-Medico di Roma, published in the journal Nature Reviews Endocrinology. The research has collected data on clinical trials conducted in recent years and underlines that the combined therapeutic approach could be the right one and should therefore be investigated further.

Type 1 diabetes, unlike type 2 which begins at an older age, is considered 'juvenile' as it affects, in one out of two cases, children under 20 years of age. "It is the most frequent chronic pathology of childhood and adolescence - explains Prof. Pozzilli - it affects two out of a thousand children and increases by about 3 percent a year". An autoimmune disease that manifests itself with the reduction of insulin production, an effect due to the destruction of the beta-cells of the pancreas by our body's defenses. Usually, at the time of diagnosis, the ß-cells are reduced by 70-80 percent, although the figure varies greatly from patient to patient.

There is currently no real cure for this pathology, which can however be kept under control thanks to the daily administration of insulin. For about ten years, however, researchers have been looking for therapies that allow the definitive resolution of type 1 diabetes. Two hypotheses that have taken hold: immunosuppressant drugs which, by counteracting the immune cells, prevent the reduction of ß -cells, and agents capable of 'regenerating' destroyed pancreatic cells.

In the study published in Nature Review Endocrinolgy, the Italian researchers examined all the therapeutic solutions tested in recent years. As far as monotherapies and combinations of immunosuppressant drugs are concerned, the studies conducted so far have not given the desired results, "probably – the authors of the research claim – both because the administration was carried out too late, when already most of the ß-cells was impaired, both because of the short duration of treatment".

Much more promising, on the other hand, are the results of experiments that have used agents capable of promoting the regeneration of beta-cells: the so-called proton pump inhibitor drugs, commonly used as antacids, administered in clinical trials together with dipeptidyl-peptidase inhibitors, medicines already in use for the treatment of type 1 diabetes. The former would stimulate the transformation of the cells present in the insulin excretory duct into beta-cells; antidiabetics, determining the increase of a hormone produced at the gastrointestinal level - the incretin glucagon-like peptide (GLP-1) - as well as inducing the differentiation of the cells of the duct, would decrease the cell death process. Despite the encouraging results, however, these type 1 diabetes treatment protocols have not yet been extended to humans.

"Combined therapy of immunosuppressant drugs and agents that promote the regeneration of ß-cells - underlines Prof. Pozzilli - would seem to be the ideal solution for definitively curing type 1 diabetes, even if it has not yet been well investigated". The Campus Bio-Medico professor adds that "since various studies have demonstrated how the reduction in the number of cells that produce insulin depends on age at the time of diagnosis, the body mass index, the degree of metabolic control and the genetic predisposition, clinical trials should be individualized, at least on the basis of the age of the patients".

"We cannot say with certainty - concludes Pozzilli - when the combined therapy approach can be introduced into clinical practice. However, since some of these drugs, including the antidiabetic GLP-1 inhibitors, are already available for diabetes type 2, hopefully the time may not be far off for their use in type 1 as well".