Insulin degludec (trade name: Tresiba) has been approved since January 2015 for adolescents and children from the age of one year with type 1 or type 2 diabetes mellitus. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether this new drug, alone or in combination with other blood-glucose lowering drugs, offers an added benefit over the appropriate comparator therapy.

No added benefit of insulin degludec for adolescents and children with type 1 diabetes mellitus can be derived from the dossier. However, in girls there is a hint of greater harm regarding serious adverse events. Since the manufacturer presented no data for adolescents and children with type 2 diabetes, no conclusion on greater or lesser benefit can be drawn for this therapeutic indication.

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/insulin-degludec-no-hint-of-added-benefit-in-children-and-adolescents.6716.html