FDA Approves Apidra for Use With Children

The addition of Apidra to the arsenal of insulins and insulin-like drugs available to treat children comes at an opportune time.

Nov 3, 2008

The FDA has approved the fast-acting insulin Apidra (insulin glulisine) for use in children four years and older who have type 1 diabetes

Apidra, manufactured by sanofi-aventis, is a rapid-acting insulin that can be administered via an insulin infusion pump, vial and syringe, insulin pen, or intravenously. Users typically inject it within 15 minutes before or 20 minutes after the start of a meal.   

The drug is usually used in conjunction with longer-acting basal insulin.

Approval for its use with children came after FDA review of a 26-week, phase III study in which Apidra's effects were compared with those of insulin lispro in 572 children at least four years old. 

The study compared changes in A1c from Apidra and insulin lispro and found that statistically, the difference between the two drugs was near zero. 

The incidence of hypoglycemia, which is the most common adverse reaction to insulin, was 7.2 percent in the Apidra users and 8.1 percent in the lispro group. 

The addition of Apidra to the arsenal of insulins and insulin-like drugs available to treat children comes at an opportune time. Worldwide, the number of children 14 years old or younger with type 1 diabetes is estimated at 440,000, with 70,000 new cases diagnosed each year. In the United States, type 1 diabetes is the most common type of diabetes in children, with approximately 176,500 people under 20 years of age affected by the disease.

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Categories: A1c Test, Apidra, Diabetes, Diabetes, Insulin, Kids & Teens, Low Blood Sugar, Type 1 Issues


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Comments

Posted by misty on 3 November 2008

Can anyone tell me the latest information on stem cell research? Are we getting any closer in being able to find a cure for our children? I have also looked at hundreds of low carb diets to try and figure out a meal plan for my 11 year old son, but I have been very unsuccessful in finding a kid friendly low carb diet. My son is a very picky eater he loves most all vegetables and fruits raw. But raw fruits and vegetables alone doesn't fill him up for very long.


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