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 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.
Original language | English |
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Pages (from-to) | 555-568 |
Number of pages | 14 |
Journal | Journal of Pediatric Endocrinology and Metabolism |
Volume | 21 |
Issue number | 6 |
State | Published - Jun 2008 |
Keywords
- Glycemic control
- Hypoglycemic events
- Inhaled insulin
- Pediatrics
- Type 1 diabetes mellitus