Jane S. Ricciuti, RPh, MS

Disclosures

June 03, 2004

In This Article

Insulins

Apidra
(insulin glulisine [rDNA origin]) Injection

Manufacturer: Aventis

Drug Approval Classification: Original New Drug Application (Approval Date: 04/16/04)

Indication: Apidra (insulin glulisine [rDNA origin]) Injection is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia.

Apidra has a more rapid onset and shorter duration of action than regular human insulin. Apidra should normally be used in regimens that include a longer-acting insulin or basal insulin analog.

Dosing: Apidra is a recombinant insulin analog that has been shown to be equipotent to human insulin. One unit of Apidra has the same glucose-lowering effect as 1 unit of regular human insulin.

Apidra should be given subcutaneously within 15 minutes before a meal or within 20 minutes after starting a meal.

Clinical Summary: Apidra is a human insulin analog that is a rapid-acting, parenteral, blood glucose-lowering agent. Apidra was studied for 26 weeks in type 1 and 2 adult diabetes patients. In a study of type 1 diabetes, Apidra was compared to insulin lispro; results demonstrated that the glycemic control, rates of hypoglycemia requiring intervention from a third party, number of daily short-acting insulin injections, and total daily doses were comparable for the 2 treatment regimens.

A 26-week, randomized, open-label, active-control study was conducted in insulin-treated patients with type 2 diabetes to assess the safety and efficacy of Apidra given within 15 minutes before a meal in comparison to regular human insulin administered 30-45 minutes prior to a meal. The reductions from baseline in hemoglobin A1c (HbA1c) were similar between treatment groups. The rates of hypoglycemia requiring intervention from a third party were comparable for the 2 treatment regimens.

Pharmacokinetics: Following subcutaneous administration of 0.15 IU/kg, the median time to maximum concentration (Tmax) was 55 minutes (range, 34-91 minutes) and the peak concentration (Cmax) was 82 micro IU (range, 42-134 micro IU) for insulin glulisine compared with a median Tmax of 82 minutes (range, 52-308 minutes) and a Cmax of 46 micro IU (range, 32-70 micro IU) for regular human insulin.

Apidra (insulin glulisine [rDNA origin]) Injection Labeling

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