Safety of insulin glulisine when given by continuous subcutaneous infusion using an external pump in patients with type 1 diabetes.

This twelve-week, European, multicenter, controlled, open-label, randomized (1 : 1), parallel-group trial compared the safety of insulin glulisine with insulin as part used in continuous subcutaneous insulin infusion. Patients with type 1 diabetes (n=59) and continuous subcutaneous insulin infusion experience (mean values: HbA1c 6.9 % [insulin glulisine: 6.8 % VS. insulin as part: 7.1 %]; age 45.8 years; body mass index 26.0 kg/m2) were enrolled. HbA1c levels at endpoint (insulin glulisine: 7.0 % VS. insulin as part: 7.2 %), daily insulin doses, blood glucose profiles and adverse event rates were similar in both groups. The median (minimum-maximum) catheter occlusion rate was low for insulin glulisine and insulin as part (0 [0 - 0.7] VS. 0 [0 - 1.1] occlusions/month. Unexplained hyperglycemia occurred in six insulin glulisine-treated patients and twelve insulin as part-treated patients. Patients were expected to change their catheters every 2 days (15 changes/month); the catheter change rate was similar for insulin glulisine and insulin as part (14.1 VS. 14.8 changes/month). The frequency of infusion site reactions and hypoglycemia, and the time between catheter changes were similar for both insulin forms. Diabetic ketoacidosis was not reported. This study supports the safety of insulin glulisine in continuous subcutaneous insulin infusion administered via an external pump in type 1 diabetes.