FDA Approves Rapid-Acting Insulin Glulisine for Children

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The US Food and Drug Administration (FDA) has approved insulin glulisine (rDNA origin) injection (Apidra) to improve glycaemic control in children aged 4 years and older with diabetes.

The approval for paediatric use is based upon an FDA review of a 26-week, phase 3, open-label, active control study comparing insulin glulisine with insulin lispro in 572 children and adolescents aged 4 years and older with type 1 diabetes.

Study patients received insulin glulisine or lispro 0 to 15 minutes premeal. These patients received concomitant treatment with insulin glargine once daily or Neutral Protamine Hagedorn (NPH) twice daily as basal insulin. The majority of the patients received insulin glargine as part of their basal-prandial regimen.

The study compared the efficacy of insulin glulisine to insulin lispro in terms of change in glycohaemoglobin (Hb A1C). The change in Hb A1C from baseline to endpoint for insulin glulisine and insulin lispro was similar.

The mean Hb A1C change in the insulin glulisine population was +0.10% (+-0.08) and +0.16% (+-0.07) in the lispro group. The difference between the 2 treatments for this measure was -0.06%, or almost 0, with a 95% confidence interval of -0.24 to 0.12. Hb A1C at baseline was 8.20% (+-1.05) in the glulisine group and 8.17% (+-1.02) in the lispro group.

Hb A1C at endpoint was 8.31% (+-1.37) in the glulisine group and 8.37% (+-1.32) in the lispro group. Postprandial glycaemic 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 hypoglycaemia. This included hypoglycaemia reported as a serious adverse reaction, which occurred in 7.2% of study patients in the glulisine group and 8.1% for those in the lispro group.