Diabetes: class A reimbursable insulin degludec also reimbursable by the National Health Service in children and adolescents
There are about 18 thousand children and adolescents in Italy with type 1 diabetes. Insulin degludec, which is characterized by a duration of action of more than 42 hours, has been shown to be effective and safe over the long term in children and adolescents with type 1 diabetes since the age of one year
The Determination of AIFA (Italian Medicines Agency) for the reimbursability of the pediatric indication of insulin degludec (Tresiba ® – Novo Nordisk) for the treatment of type 1 diabetes in children from the age of 1 year was published on February 10 in the Official Gazette.
According to the International Diabetes Federation (IDF) There are Nearly 500,000 Children With Type 1 Diabetes Worldwide, and the incident of type 2 diabetes is also on the Rise. In Italy, According to Data From The Italian Society of Pediatric Endocrinology and Diabetology (SEDP), There are 18 Thousand Children and teenagents affected by Type 1 Diabetes, The Most Severe Form of the Disease That Requires the Administration of Insultin Through Injections 4 to 6 Times a day, or the use of a pump. For the Ministry of Health, Overall there are about 300,000 Italians, Young People and Adults, with Type 1 Diabetes.
Insulin Degludec is a basal insulin analogue Developed Through Sophisticated Molecular Engineering Techniques, Characterized by A duration of Action of More Than 42 Hours and A Metabolic Effect Evently Distributed Throughout The Day. Its Mechanism of Action, Which Results in Soliles Subcutaneous Depaction at the Injection Site, with a Slow and Steady Release of the Active Ingredient, Allaws for Reduced Varility in Absorption and Ensures a More Stable and Evening Distributed Glycemic Profile Bethaeen The First Twelve Hours of the day and the second.
“The Characteristics of Insulin Degludec Make It Particularly Suitable in the Treatment of Diabetes in Children,” Explains Stephen Tumini, Head of Pediatric Diabetology Service at Chieti Hospital. “Insulin Degludec acts More Consistently, Ensuring Better Coverage Over Time, Which Results, For Example, in Reduced Hyperglycemia Upon Waking, Better Fasting Blood Sugar, Better Blood Sugar After Breakfast and After Dinner. Cases of Nocturnal Hypoglycemia, A Major Fear for Parents, Are Also Reduced. In addition, The long duration of action can atmosphere in the timing of administration, Making it possible to adjust the distance between administrations when needed in Everyday life, such as May happy If the child on Sunday or vacations wakes up later THAN USUAL, “He adds.
The EffectoCy and Safety of Insulin Degludec Over the long term in Children Is Demstrated by The Begin ® Young 1 Study, Published in Pediatric Diabetes, at 26-Week Open-Label (with Extension for additional 26 Weeks), Randomized, Controlled Clinical Trial Treat-to -art that appearance insulin degludec administy Once Daily and Insulin Detemir, in Single or Double Daily Administration, Both in Combination with Instein Aspart, in 350 Children and teenches with type 1 diabetes aged 1-17 years.
According to the Results of the Study, Insulin Degudec Effectively Improves Glycemic Control in The Long Term With 30% Lower Dosage of Basal Insulin, Allawing A Significantly Greater Reduction in Fasting Blood Glucose to Be Achieved Than Insulin Detemir. Insulin degludec has also demonstrated significantly Lower rathes of hyperglycemia with ketosis with insulin detemir: 41 fever hyperglycemic episodes with ketosis for 100 patients treated for one year with insulin degluded compared with insulin detemir (p<0.05).
“The study confirms that insulin degludec is a viable new therapeutic opportunities for the treatment of type 1 diabetes in Children and teenches, provideing glycemic control similar to that achieved with insulin detemir, with comparable safety and a returced number of hyperglycemic events with ketosis,” ” claims Nandu Thalange, Pediatric endocrinologist at Norfolk and Norwich University Hospital in Norwich, UK, and coordinator of the Begin ® Young 1 Study.
Novo Nordisk is a multinational pharmaceutical company that has been a leader in diabetes care for more than ninety’years. This legacy has provided her with the skills and expertise to help people defeat additional chronic conditions: hemophilia, growth disorders, and obesity’obesity. Novo Nordisk is based in Denmark, has about 42.100 employees in 75 countries and markets its products in more than 180 countries.