FDA Approves Rapid-Acting Insulin Apidra for Treatment of Children with Diabetes

Sanofi-aventis announced last week, that the U.S. Food and Drug Administration (FDA) approved Apidra(R) (insulin glulisine [rDNA origin] injection) to improve glycemic control in children (4 years and older) with diabetes.

Apidra(R) has a rapid onset and short duration of action and should normally be used in combination with a longer-acting or basal insulin. Apidra(R) can also be used in insulin infusion pump therapy for blood sugar control.

The approval of Apidra(R) for pediatric use is based upon a 26-week, phase III, open-label, active control study of Apidra(R) 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(R) and insulin lispro treated groups, respectively).

The study compared the efficacy of Apidra(R) to insulin lispro in terms of change in glycohemoglobin (HBA1c). The change in HBA1c from baseline to endpoint for Apidra(R) and insulin lispro were similar. The mean HBA1c change in the Apidra(R) population was +0.10% and +0.16% 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 HbA1c at baseline was 8.20% in the glulisine group and 8.17% in the lispro group, HbA1c at endpoint was 8.31% in the glulisine group and 8.37% 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.

Apidra(R) is a rapid-acting insulin that can be administered using an insulin infusion pump, vial and syringe, the OptiClik(R) reusable insulin pen, or intravenously under proper medical supervision in a clinical setting. Apidra(R) works fast and offers flexible insulin dosing to help manage mealtime blood sugar levels. It should be administered within 15 minutes before or within 20 minutes after the start of a meal. Along with exercise, a basal insulin, and a proper meal plan, Apidra(R) is proven to help reduce A1C levels in adults and children (4 years and older) with type 1 diabetes and adults with type 2 diabetes.
For full prescribing information, please visit www.Apidra.com

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