The EU-TERAT study confirms the reduction of blood sugar and episodes of hypoglycaemia with insulin degludec
The EU-TERAT study confirms the reduction of blood sugar and episodes of hypoglycaemia with insulin degludec in real clinical practice
The results of the European Real-World Evidence study, which it evaluated out of 2.550 people with type 1 and 2 diabetes what happens in clinical practice when transition from a basal insulin previous to Insulina Degludec, presented at the 77th Ada congress in San Diego
The results of the Real-World Study Evidence Eu-Treat (European Tresiba Audit) were presented today at the 77th Congress of the ADA (American Diabetes Association) in San Diego, US. The results of this study showed how people with type 1 and 2 diabetes, six months after the change of therapy from another previous basal insulin, mainly insulin glargine 100 U and insulin detemir, obtain, with the transition to insulin Degludec (Tresiba ®, Novo Nordisk) a significant reduction in the values of glyted hemoglobin (HBA1C, -0.2 percent for type 1 and -0 diabetes.5 percent for type 2 diabetes), in conditions of real clinical practice. These results are also confirmed by the 12 -month analysis. 1.2
Hypoglycaemia rates also proved to be significantly lower six months after the transition to insulin Degludec. In people with type 1 diabetes, severe hypoglycaemias reduced by 85 percent, and 92 percent in people with type 2 diabetes. 12 months hypoglycaemia rates remain in line with the results of the first 6 months.
In addition, after six months there was a significant reduction in fasting blood sugar (-18.7 mg/dl for patients with type 1 diabetes, and -23.7 mg/dl for patients with type 2 diabetes), Also in this case, these reductions have been confirmed to 12 months. 1.2
Finally, the daily dose of insulin assumed has significantly decreased in people with type 1 diabetes (-4.9 units) as in those with type 2 diabetes (-2.5 units) after 6 months, and remained stable later The 12 months. 1.2
“The use of a new drug always passes through controlled randomized clinical studies carried out on a selected population of patients,” he explains Annunziata Lapolla, Associate Professor of Endocrinology, Dimed, University of Padua. “However, the data obtained from these studies are not necessarily replicable in real life. For this reason, for years, it has been given as much importance to observational studies, carried out on a varied population of patients, the one that is really encountered in the clinics, studies that allow you to find confirmation of those results on the field.
Clinical studies on insulin Degludec had created great expectations that Eutreat confirms in full, above all, as regards the reduction of hypoglycaemias, which in many cases represent one of the main concerns for people with diabetes “.
“Real-World Evidence (RWE) studies, which aim to verify in daily life what happens in the ideal environment of randomized and controlled clinical trials, are important to understand how the outcome of clinical studies then translate into the real world” , he claims Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer of Novo Nordisk. “The data presented at ADA confirm what is seen in the phase IIIA/IIIB clinical trials, demonstrating better glycemic control and a significantly reduced risk of hypoglycaemia in patients who have carried out the transition to insulin for another basal insulin, such as insulin glargine and insulin detemir “.
The EU-TREAT (European Tresiba Audit) is a European, multicenter, Real-World Evidence study, conducted on 2.550 people with type 1 diabetes (n = 1.717) and type 2 (n = 883), the purpose of which was to analyze the effects of the transition from any basal insulin prior to insulin degludec. The patients involved carried out the transition from the therapy with basal insulin prior to insulin degludec 6 months before the data collection. The results were measured after 6 (± 3) and 12 (± 3) months from the transition to insulin Degludec and were compared, compared to a data recorded at the Baseline during the previous therapy with basal insulin, in the three months prior to the passage to insulin degludec. 1.2
Insulin Degludec (Tresiba ®) is a basal insulin in a daily administration that guarantees a duration of action greater than 42 hours, with a stable effect of reducing blood sugar. 3.4 The insulin Degludec is characterized by a low daily variability and a reduced risk of total, night and serious hypoglycaemias compared to the insulin Glargine 100 U 3.5 . When administration at the same time of the day is not possible, insulin degludec allows a more flexible dosage, with a minimum of eight hours and a maximum of forty between two consecutive administrations, maintaining the same profile of efficacy and safety. 3
Insulin Degludec obtained the first regulatory approval in September 2012 and has since been approved in over 80 countries around the world. At the moment it is available on the market in over 50 countries.
Novo Nordisk is a pharmaceutical multinational that has been a leader in the treatment of diabetes since nineties. This heritage provided her with the skills and skills to help people defeat further chronic pathologies: l ’ Hemophilia, growth disorders and obesity. Novo Nordisk is based in Denmark and has about 42.000 employees in 77 countries and markets its products in more than 165 nations.