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FDA OKs insulin determir for use in young children

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Insulin detemir (Levemir, Novo Nordisk) has been approved by the FDA for use in children aged 2 to 5 years with type 1 diabetes.

“Our biggest challenges and top priorities when treating some of the youngest children with type 1 diabetes are safety and reducing the risk of hypoglycemia,” Mark A. Sperling, MD, editor-in-chief of Pediatric Diabetes and Endocrine Today Editorial Board member, said in a press release. “Levemir, with its approval from the FDA, is a particularly welcome addition to our treatment options for some of our youngest patients with type 1 diabetes.”

Mark A. Sperling

The decision came after data showed that insulin detemir (Levemir, Novo Nordisk) is as effective for children aged 2 to 5 years with type 1 diabetes when compared with Neutral Protamine Hagedorn insulin. Mean HbA1c was similar between groups at baseline (8.2% in the insulin detemir group vs. 8.1% in the NPH group) and at 1 year after treatment (8.1% vs. 8.3%). No severe hypoglycemic episodes were reported.

Insulin detemir is the first basal insulin analog approved for use in this patient population.

In September 2011, a similar indication for insulin detemir’s use in children was approved in Europe.