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Efficacy and Safety of Inhaled Human Insulin (Exu hera®) Compared to Subcutaneous Insulin in Children Ages 6 to 11 Years with Type 1 Diabetes Mellitus: Results of a 3-Month, Randomized, Parallel Trial
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Published/Copyright:
October 22, 2020
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.
Keywords: type 1 diabetes mellitus; inhaled insulin; pediatrics; hypoglycemic events; glycemic control
Published Online: 2020-10-22
Published in Print: 2008-06-01
© 2020 by Walter de Gruyter Berlin/Boston
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Keywords for this article
type 1 diabetes mellitus;
inhaled insulin;
pediatrics;
hypoglycemic events;
glycemic control
Articles in the same Issue
- TITLE
- TABLE OF CONTENTS
- EDITORIAL. Why the Consensus for Consensus?
- REVIEW. Translating Transition: A Critical Review of the Diabetes Literature
- SOCIETY NEWS. VanWyk Award Acceptance Speech, May 5, 2008
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