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FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes
Date:10/29/2008

) 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(R) and insulin lispro were similar. The mean HBA1c change in the Apidra(R) 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.

About Diabetes

Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. In type 1 diabetes, the immune system destroys the insulin-producing beta cells of the pancreas that regulate blood glucose. Since the pancreas can no longer produce insulin, people with type 1 diabetes require daily injections of insulin for their entire lives.

The International Diabetes Foundation estimates the global number of children 14 years of age and younger with type 1 diabetes to be 440,000, with 70,000 newly diagnosed cases each year. In the United States, type 1 diabetes is the most common type of diabetes
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SOURCE Sanofi-aventis
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