Diabetes, from Real World data confirmations for second generation insulins

In the treatment of type 2 diabetes, second generation basal insulins improve glycemic control with a low risk of hypoglycemia and serious adverse events even in Real World and not only in pivotal studies. It is a very important fact because in real life patients are not selected and often turn out to be complex, as they suffer from multiple concomitant pathologies. Proof of this is the multicenter retrospective non-inferiority study ‘Restore-2’, which for the first time compared the efficacy and safety of the second generation basal insulins Glargine-300 and Degludec-100 in a heterogeneous population of patients with type 2 diabetes, through data from clinical practice. The results of the naïve cohort were discussed in an oral presentation at the 2021 Virtual annual meeting of the European association for the study of diabetes (Easd) which has just ended. In naïve adult patients (not previously treated with insulin), Gla-300 (insulin glargine 300 U / mL) and Deg-100 (insulin degludec 100 U / mL) resulted in comparable glycemic control six months after starting therapies. with a significant reduction in both groups, without weight gains occurring. From a safety perspective, the risk of hypoglycemia was very low, with no serious adverse events. After 12 months of treatment, the reduction in glycated hemoglobin (HbA1c) was maintained in both groups, although the reduction was nominally greater in the Gla-300 group. Basal insulin titration was not optimal in both groups. The ‘Restore-2’ study, entirely Italian, involved 19 hospital centers and was coordinated by the Department of Medicine of the University of Padua, the Department of Experimental Medicine of Sapienza University of Rome, the Department of Medicine of the University of Messina and the Center for Outcomes Rsearch and Clinical Epidemiology (Coresearch) of Pescara. “The ‘Restore-2 Naive’ study is important for at least two reasons – explained Gian Paolo Fadini, associate professor of Endocrinology at the University of Padua – On the one hand because it provides, for the first time, a photograph of how type 2 diabetes is treated in patients who start basal insulin therapy in clinical practice daily diabetology, and represents a point of reference in the European panorama as regards the comparison of second generation insulins in the Rea setting l World. The data indicate that the two second generation insulins have a comparable efficacy and a good safety profile also in the Real World, and not only in the registration studies. A good balance between efficacy and safety can therefore be achieved even in the complex and unselected patient. This – he stresses – should push clinicians and patients to use basal insulins with greater confidence to ensure better titration of insulin therapy and therefore also a better overall management of type 2 diabetes ”. In normal clinical practice – a note reads – there is, in fact, a certain inertia in the management of insulin therapy, partly due to the fear of hypoglycemia, partly due to the complexity of the measurements, or because the algorithm for evaluating blood glucose on an empty stomach it must be personalized and it may not be immediate to apply it. These ‘barriers’ are at the basis of the therapeutic inertia towards patients with type 2 diabetes who, in this case, would need to be treated more, also thanks to the availability of new, safer therapeutic aids. “There is a certain complexity in management. of type 2 diabetes – continues Fadini – that second generation insulins help to overcome: the low variability over 24 hours and from one day to the next should allow the insulin to be titrated more effectively, achieving further reductions of glycated hemoglobin, and this can have an important impact on clinical practice “.