>>GLASGOW, Scotland, Sept. 10 /PRNewswire/ -- New data presented today at the European Association for the Study of Diabetes (EASD) demonstrated that the revolutionary AERx® iDMS electronic pulmonary insulin system, which is currently in clinical development, did not adversely impact respiratory function in patients with asthma. The results presented today suggest that AERx iDMS could be a viable option for the treatment of diabetes in people who also have asthma.
The data was presented during the session on 'Oral and Pulmonary Insulin' and is the first time information of this type has been presented on pulmonary insulin. The data was based on a recently completed study involving nondiabetic subjects. The AERx iDMS was previously shown in single-dose studies to be well tolerated and to lower blood glucose in healthy individuals and people with diabetes.
As the AERx® iDMS uses the lungs for insulin delivery, physicians were keen to have confirmation that this mode of insulin delivery did not have adverse reactions in those patients with respiratory diseases such as asthma and that it would not induce asthma-like attacks in non-asthmatic individuals. ``These results are very encouraging. With such a novel and exciting product as this, physicians are eager for it to be an option for as broad a group as possible provided that solid safety and efficacy data is available,'' said lead investigator of the study, Dr. Robert Henry, VA, San Diego Healthcare System.
The study was conducted in 45 non-diabetic participants, 28 non-asthmatics and 17 chronic asthmatics, to investigate the safety and tolerability of inhaled insulin via the AERx iDMS system in both healthy and asthmatic subjects. All subjects were non-smokers and between the ages of 18 and 45 years old. The subjects were administered insulin over three separate dosing days, which included six AERx-unit doses on two days, moving up to a 17 AERx-unit dose on the third dosing day. (One AERx unit is designed to provide the same glucose-lowering effect as one subcutaneous insulin unit.)
For the asthmatic patients, the results determined that use of the AERx iDMS did not provoke asthmatic attacks or worsen the baseline airway hyperreactivity state of the asthmatic subjects, even with higher doses. Both groups showed the same tolerance for the AERx iDMS. Interestingly, the asthmatic patients absorbed less insulin as compared to healthy participants with a resultant decreased reduction in blood glucose. The study indicates that diabetic asthmatics will likely have to inhale more insulin to achieve the same amount of glycemic control as their non-asthmatic counterparts. The most common adverse events from study were hypoglycemia and headache.
Dr. Per Clauson, Clinical Development, Novo Nordisk, commented on the results, ``This is promising news for the treatment of asthmatic patients with AERx iDMS. However, these patients need to be studied in larger populations.'' He further stated that ``based on the positive results from this trial, asthma will not be an exclusion criteria in our future trials.''
The AERx iDMS electronic system is a product designed to address all the important criteria for a pulmonary delivery system. Early clinical trials to date show that use of the AERx iDMS results in a lung delivery of insulin that lowers blood glucose in a reproducible manner. Novo Nordisk is developing the AERx iDMS in partnership with Aradigm Corporation (Nasdaq: ARDM - news) of Hayward, California.
AERx iDMS has a unique electronic ``Breath Control'' feature. ``Breath Control'' guides patients to the correct breathing technique, which ensures deep lung delivery of the insulin dose. The system also features the ability to adjust the insulin dose in single AERx unit increments and a unique data downloading system that will allow patients to review dosing data and may potentially lead to good patient compliance.
The AERx iDMS is designed to be user friendly so that people with diabetes can use it with ease. This unique system could present a solution for patients, particularly those who have an aversion toward self-administered injections, both because of the perceived stigma associated with needle use, and because of a general fear of injections. It is significant that people with diabetes who have asthma can be included in further trials and may benefit from this new alternative for a disease considered to be a worldwide epidemic.<<
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