Two types of insulin analogs were equally safe and effective when used in insulin pumps by children and adolescents aged 4–18 years, according to results from a study of 298 children.
The popularity of continuous subcutaneous insulin infusion (CSII) for children and adolescents with type 1 diabetes has increased, despite limited safety and effectiveness data, in part because many children and teens prefer the customized insulin delivery of a pump rather than multiple daily insulin injections.
Results from previous studies have shown that both insulin lispro and insulin aspart are safe and effective for CSII in adults with type 1 diabetes, and that CSII is as effective as multiple daily insulin injections. But this study is the first to compare the safety and effectiveness of two insulin analogs for CSII in a pediatric population (Diabetes Care 2008;31:210–5).
In this open-label study sponsored by Novo Nordisk Inc. (the manufacturer of insulin aspart), Dr. Stuart A. Weinzimer of Yale University, New Haven, Conn., and his colleagues randomized 198 children to use insulin aspart and 100 children to use insulin lispro for CSII. The intent-to-treat population included 197 children in the aspart group and 99 children in the lispro group.
The children's hemoglobin A1c (HbA1c) was assessed at baseline and again after 8, 12, and 16 weeks, and the primary outcome was the change from baseline to week 16.
Overall, the changes in HbA1c were not significantly different between the two groups in the intent-to-treat population. The average HbA1c values decreased from 8.0% at baseline to 7.9% at 16 weeks in the aspart group, and from 8.2% at baseline to 8.1% at 16 weeks in the lispro group.
In addition, 60% of the children in the aspart group and 44% of the children in the lispro group met the American Diabetes Association's age-specific recommendations for HbA1c (less than 8% for children and adolescents aged 6–18 years, and less than 8.5% for children younger than 6 years) after 16 weeks, compared with 50% and 40%, respectively, who met those criteria at baseline.
The average fasting plasma glucose values were similar between the two groups at baseline and at the end of the study. As would be expected in a pediatric trial, children in both groups gained weight, but the average weight gain was not significantly different between the two groups (1.8 kg in the insulin aspart group vs. 1.6 kg in the insulin lispro group).
Overall, the incidence of adverse events was similar in the aspart and lispro groups (82% vs. 83%). But the majority of these events were mild, and the most common complaints included upper respiratory tract infections, hyperglycemia, and nasopharyngitis. Six children reported serious adverse events, but none of them discontinued the study as a result of these events. One child in the lispro group developed hypoglycemia, and five children in the aspart group reported hyperglycemia, hypoglycemic seizure, diabetic ketoacidosis, hypoglycemia with accidental overdose of insulin, and skin lacerations.
The average daily dose of insulin in the aspart group was significantly lower after 16 weeks, compared with the lispro group (0.86 units/kg vs. 0.94 units/kg), but the overall rates of hypoglycemia were similar in both groups, the researchers noted.
The clinical implication of the findings is that insulin aspart and insulin lispro are equally effective when used in insulin pumps to treat children and teens with type 1 diabetes, the researchers said. Regardless of the type of insulin analog used, the findings support the use of insulin pumps for young type 1 diabetes patients who want greater convenience and flexibility in managing their condition.