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.

Abstract

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.

• Authors: Neil H White, Teresa Quattrin, Lisa B St Aubin, William T Duggan, Richard D England, Julie S Fryburg
• Journal: Journal of pediatric endocrinology & metabolism : JPEM (J Pediatr Endocrinol Metab) Vol. 21 Issue 6 Pg. 555-68 (Jun 2008) ISSN: 0334-018X [Print] Germany
• PMID: 18717242 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies
• Blood Glucose
• Exubera
• Glycated Hemoglobin A
• Insulin
• hemoglobin A1c protein, human

Topics

• Administration, Inhalation
• Algorithms
• Antibodies (blood)
• Blood Glucose (analysis, drug effects)
• Child
• Child, Preschool
• Diabetes Mellitus, Type 1 (blood, drug therapy)
• Glycated Hemoglobin (analysis)
• Humans
• Injections, Subcutaneous
• Insulin (administration & dosage, adverse effects, immunology)
• Lung (drug effects, physiology)
• Treatment Outcome