The FDA based its decision on results from a randomized, open-label, two-way crossover study of 16 healthy male subjects who received an intravenous infusion of Apidra or regular human insulin with saline diluent at a rate of 0.8 IU/kg/min for two hours. Infusion of the same dose of Apidra or regular human insulin produced equivalent glucose disposal at steady state.
In addition to intravenous use, when treating type 1 or type 2 diabetes patients with hyperglycemia in a clinical setting, Apidra can be administered in vial form, insulin pen, or external insulin infusion pump.
“Many of the patients I treat in the inpatient setting have diabetes and require intravenous insulin,” said Christopher A Newton, assistant professor of medicine, East Carolina University. “The new indication for Apidra is an important development, as it gives clinicians a new option to help achieve and maintain blood glucose control in these patients in this setting.”
Apidra was approved in April of 2004 for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia.