FDA Approves Rapid-Acting Insulin Apidra
Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved Apidra (insulin glulisine [rDNA origin] injection) to improve glycemic control in children (4 years and older) with diabetes mellitus.
The approval of Apidra for pediatric use is based upon FDA review of a 26-week, phase III, open-label, active control study of Apidra in comparison with insulin lispro, in 572 children and adolescents (4 years and older) with type 1 diabetes.
"Sanofi-aventis is committed to providing children with diabetes, as well as their families and healthcare providers, with safe and effective treatment options to help address the challenges associated with the condition and to help decrease the long-term risk for devastating complications of diabetes," said Michelle Baron, MD, vice president, Metabolism Medical Unit, sanofi-aventis U.S. "We are pleased that the fast onset of action and mealtime dosing flexibility of Apidra will now be available to children 4 years and older."
Apidra has a rapid onset and short duration of action and should normally be used in combination with a longer-acting or basal insulin. Apidra can also be used in insulin infusion pump therapy for blood sugar control.
About the Study
The approval of Apidra for pediatric use is based upon a 26-week, phase III, open-label, active control study of Apidra in comparison with insulin lispro in 572 children and adolescents (4 - 17 years of age) with type 1 diabetes. Study patients received insulin glulisine or lispro 0-15 minutes premeal. These patients received concomitant treatment with insulin glargine once daily or NPH twice daily as basal insulin. The majority of the patients received insulin glargine as part of their basal-prandial regimen (69.7% and 72% in the Apidra and insulin lispro treated groups, respectively).
The study compared the efficacy of Apidra to insulin lispro in terms of change in glycohemoglobin (HBA1c), which is the amount of sugar bound to hemoglobin in the blood. The change in HBA1c from baseline to endpoint for Apidra and insulin lispro were similar. The mean HBA1c change in the Apidra population was +0.10% (+ or - 0.08) and +0.16% (+ or - 0.07) in the lispro group. The difference between the two treatments for this measure was -0.06%, or almost zero, with a 95% confidence interval of (-0.24; 0.12). HbA1c at baseline was 8.20% (+ or - 1.05) in the glulisine group and 8.17% (+ or - 1.02) in the lispro group, HbA1c at endpoint was 8.31% (+ or - 1.37) in the glulisine group and 8.37% (+ or - 1.32) in the lispro group. Postprandial glycemic control, as assessed by the self-monitored blood glucose values and blood glucose excursions, was similar in both treatment groups at endpoint.
No noteworthy differences existed between treatment groups in the number of study patients reporting hypoglycemia, which is the most common adverse reaction of insulin therapy. This included hypoglycemia reported as a serious adverse reaction, which occurred in 7.2 percent of study patients in the glulisine group and 8.1 percent of those in the lispro group.