Rapid-acting insulin approved for IV use

June 25, 2007

Adult patients with Type 1 or 2 diabetes will now have the option of receiving insulin glulisine (rDNA origin) injection (Apidra, Sanofi-Aventis) by intravenous infusion while under medical supervision in a clinical setting.

Adult patients with Type 1 or 2 diabetes will now have the option of receiving insulin glulisine (rDNA origin) injection (Apidra, Sanofi-Aventis) by intravenous infusion while under medical supervision in a clinical setting. The FDA approved the sNDA for the product following review of an open-label, crossover study of 16 healthy male patients who received an infusion of the insulin in saline diluent for two hours at a rate of 0.8 IU/kg/min. According to the manufacturer, infusion of the same dose of Apidra or regular insulin produced equivalent glucose disposal at steady state. Apidra was originally approved in 2004 for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia.

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