Data on Use of AERx Pulmonary Insulin Delivery System in Smokers and Patients With Asthma Published
Monday March 17, 6:02 am ET
- System Proven to be Safe and Well Tolerated - Reproducible Dosing Achieved
HAYWARD, Calif., March 17 /PRNewswire-FirstCall/ -- Results of two separate clinical studies from the AERx® Insulin Diabetes Management System (iDMS) Phase 2 program show that the AERx iDMS is safe, well tolerated and produces reproducible dosing in patients with asthma and smokers. The studies are a result of the collaboration between Aradigm Corporation (Nasdaq: ARDM - News) and Novo Nordisk. The two papers appear in the March 2003 issue of Diabetes Care, a journal of the American Diabetes Association.
In the paper entitled: "Inhaled Insulin Using the AERx Insulin Diabetes Management System in Healthy and Asthmatic Subjects" by Henry, R, et al. researchers examined a group of 45 non-diabetic, non-smoking subjects of which 17 were diagnosed with chronic mild to moderate asthma. Results from the study showed that asthmatic patients consistently exhibited less insulin absorption and, as a result, lower reduction of blood glucose levels when compared to the control group. However, median times to maximal concentration (Tmax) of serum insulin levels between the healthy (Tmax =50 min) and the asthmatic (Tmax= 45 min) were comparable and shorter than normally seen with subcutaneous administration by injection. These results indicate that although the pulmonary delivery of insulin was well tolerated, patients with asthma may require a greater intake of insulin to control their blood glucose, due to changes in the upper airways associated with the disease. No significant changes were observed in lung function measurements after dosing. All doses in both parts of the study were well tolerated by both groups.
A second paper, entitled "The Impact of Smoking on Inhaled Insulin" by Himmelmann, A., et al. describes the pharmacokinetics (PK) of inhaled insulin in 27 nondiabetic smokers and 16 nonsmokers. Overall PK results showed that roughly 60% more insulin was absorbed in smokers versus non-smokers. Comparable low intrasubject variability in smokers and nonsmokers demonstrate the reproducibility of the AERX iDMS irrespective of smoking. Further studies are planned to characterize the use of the AERx iDMS in smokers.
"All patients requiring insulin must be adjusted individually whether given insulin by injection or by inhalation," said Dr. Tunde Otulana, Vice President of Clinical and Regulatory Affairs at Aradigm. "The key is to achieve reproducible dosing so that patients receive the dose that they expect, every time."
"These data provide valuable information on the use of the AERx iDMS in important diabetic patient subpopulations," said Richard Thompson, President and Chief Executive Officer of Aradigm. "In each of the studies, reproducible dosing with the AERx System was achieved in patients with pre-existing lung conditions. We believe that precise individual dose adjustment, which is critical for these patients, is possible with the AERx iDMS." |
