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Title: FDA Approves First Insulin Analog for Use in Insulin Pumps by Children, Adolescents

"FDA Approves First Insulin Analog for Use in Insulin Pumps by Children, Adolescents"

NEW YORK -- March 18, 2008 -- The US Food and Drug Administration (FDA) has approved insulin aspart (rDNA origin) injection (NovoLog) for continuous subcutaneous insulin infusion (CSII) by external insulin pump in paediatric patients aged 4 to 18 years. It is the first and only insulin analog approved for this use. Data from a trial published in the February 2008 issue of [Diabetes Care demonstrated that insulin aspart injection achieved similar levels of glycaemic control and safety compared with insulin lispro CSII.

The study results came from a 16-week, open-label, multicentre, parallel group trial of 298 patients (aspart, n = 198; lispro, n = 100) who were aged 4 to 18 years; had type 1 diabetes for 1 year or more; whose CSII therapy treatment lasted 3 months or longer; and had A1C less than or equal to 10% at screening.

Patients were randomised 2:1 to insulin aspart injection CSII or insulin lispro CSII via an external pump, with changes in reservoir, infusion set, and infusion site at least once every 48 hours. Patients were stratified by age (ie, 3-5 y, 6-11 y, 12-18 y) before randomisation.

At the conclusion of the study, both treatments resulted in comparable changes in baseline A1C. Nearly 60% of the participants given insulin aspart injection achieved age-specific A1C goals -- defined by the American Diabetes Association as <8.5% for subjects aged <6 years and <8% for subjects aged 6 to 18 years -- compared with 43.8% of patients given insulin lispro.

In addition, the weight-adjusted mean daily dose of insulin aspart injection was significantly less than insulin lispro (0.86 unit/kg vs 0.94 unit/kg; P = 0.018). Rates of hypoglycaemia and numbers and types of adverse events were similar between both treatment groups.

"[Insulin aspart injection] CSII was shown to be safe and tolerable in paediatric subjects between the ages of 4 and 18 years old," said lead study author Stuart A. Weinzimer, MD, Associate Professor, Department of Pediatrics, Yale University School of Medicine, New Haven, Conn. "The results of this study confirm that [insulin aspart injection] CSII therapy is efficacious in appropriately selected children and adolescents."

SOURCE: Novo Nordisk

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