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Insulin Degludec (Tresiba) Demonstrates Long-Term Efficacy in Children and Adolescents With Type-1 Diabetes
New clinical data from the BEGIN Young 1 trial have been announced at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). The trial investigated once-daily insulin degludec (Tresiba, Novo Nordisk) compared with insulin detemir (Levemir, Novo Nordisk), both in combination with bolus insulin aspart (NovoLog, Novo Nordisk), in a 52-week trial in children and adolescents with type-1 diabetes.
The results showed that insulin degludec in combination with insulin aspart effectively improved long-term glycemic control.
The BEGIN Young 1 trial was a 26-week, randomized, controlled, open-label, treat-to-target study (with a 26-week extension) investigating the efficacy and safety of insulin degludec, given once daily, and insulin detemir, given once or twice daily, both in combination with bolus insulin aspart, in children and adolescents with type-1 diabetes.
Insulin degludec met the primary endpoint of non-inferiority to insulin detemir for the mean change in hemoglobin A1c (P < 0.05) at 26 weeks. In the 26-week extension, a lower insulin dose and a significantly greater reduction in fasting plasma glucose were achieved compared with insulin detemir (P < 0.05).
Both regimens had similar rates of overall and nocturnal hypoglycemia, but the rate of severe hypoglycemia was numerically higher with insulin degludec plus insulin aspart. Of note, patients treated with insulin degludec had significantly lower rates of hyperglycemia with ketosis (P < 0.05). Adverse-event profiles were similar for insulin degludec and insulin detemir.
Insulin degludec is a once-daily basal insulin that provides a duration of action beyond 42 hours. On occasions when administration at the same time of day is not possible, insulin degludec allows flexibility in day-to-day dosing times.
Source: Novo Nordisk; September 16, 2014.