Insulin Analog Cleared for Use in Pumps by Pediatric Patients

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The FDA has cleared NovoLog (insulin aspart [rDNA origin] injection) from Novo Nordisk for continuous subcutaneous insulin infusion (CSII) by external insulin pump in pediatric patients aged 4-18 years.

 

It is the first and only insulin analog approved for this use. Data from a trial published in Diabetes Care (2008;31:210-215) in support of the approval demonstrated that compared to insulin lispro CSII, NovoLog CSII achieved similar levels of glycemic efficacy and safety.

 

Results came from a 16-week, open-label, multicenter, parallel group study of 298 patients.

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