Efficacy and safety of inhaled human insulin (Exubera®) compared to subcutaneous insulin in children ages 6 to 11 years with type 1 diabetes mellitus: Results of a 3-month, randomized, parallel trial

Aim: To compare the efficacy and safety of Exubera® (EXU) with subcutaneous (SC) insulin in children, ages 6-11 years, with type 1 diabetes mellitus. Design and Methods: 121 children were randomized to receive EXU or SC insulin, plus intermediate/long-acting insulin for 12 weeks. Change in HbA_1c was the primary efficacy endpoint. Results: Decreases from baseline HbA_1c were comparable between treatment groups (difference between adjusted mean decrease from baseline [EXU - SC insulin], -0.23 [95% CI, -0.49, 0.03]). Differences between groups on pulmonary function tests wero small and not significant. Mild to moderate cough occurred in 24.6% of EXU versus 6.8% of SC insulin patients. The risk for hypoglycemia was comparable between EXU and SC insulin (relative risk 0.88 [95% CI, 0.71, 1.11]). Increased insulin antibodies with EXU were not associated with clinical findings. Conclusion: The efficacy and safety profiles shown in this study are the foundation for further investigation of EXU in this population.