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.
OBJECTIVE
To compare the efficacy and safety of Exubera (EXU) with subcutaneous (SC) insulin in children, ages 6-11 years, with type 1 diabetes mellitus.


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.


CONCLUSIONS
The efficacy and safety profiles shown in this study are the foundation for further investigation of EXU in this population.
White
Neil H
NH
Department of Pediatrics, Washington University School of Medicine, St. Louis, MO 63110, USA. white_n@kids.wustl.edu
Quattrin
Teresa
T
St Aubin
Lisa B
LB
Duggan
William T
WT
England
Richard D
RD
Fryburg
Julie S
JS
D000280:Administration, Inhalation; D000465:Algorithms; D000906:Antibodies / Q000097:blood; D001786:Blood Glucose / Q000032:analysis / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D008168:Lung / Q000187:drug effects / Q000502:physiology; D016896:Treatment Outcome
D000906:Antibodies; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007328:Insulin; C473734:Exubera; C517652:hemoglobin A1c protein, human