Health & Environmental Research Online (HERO)


Print Feedback Export to File
3877864 
Journal Article 
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 
White, NH; Quattrin, T; St Aubin, LB; Duggan, WT; England, RD; Fryburg, JS 
2008 
1 
Journal of Pediatric Endocrinology & Metabolism
ISSN: 0334-018X
EISSN: 2191-0251 
21 
6 
555-568 
English 
18717242 
WOS:000258110300008 
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. 
type 1 diabetes mellitus; inhaled insulin; pediatrics; hypoglycemic events; glycemic control