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 HbA1c was the primary efficacy endpoint.
Results: Decreases from baseline HbA1c 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 were 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.
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