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| | | ![]() Inhaled Insulin May Allow Diabetics to Control Meal-Time Glucose Levels HAYWARD, Calif., April 28, 1997 -- The results of a clinical study on the pulmonary delivery of insulin show that it may be possible for people with diabetes to control meal-time glucose levels by inhaling insulin. The insulin in this study was delivered by a prototype device that is part of the AERx(TM) Diabetes Management System developed by Aradigm Corporation. Inadequate control of meal-time glucose levels is known to cause serious long-term medical problems for diabetics. Many patients fail to take their meal-time insulin because it must be delivered by subcutaneous injection. A non-invasive inhaled insulin may allow more patients to better control their glucose levels and therefore delay or avoid many of the long-term complications associated with diabetes. The results also indicate that control over the way in which an individual is breathing while the insulin dose is being inhaled is important for achieving a reproducible therapeutic effect. The results were presented by Dr. Igor Gonda, Aradigm vice president of research and development, at the Western Regional Meeting of the American Association of Pharmaceutical Scientists held on April 24-25, 1997 in South San Francisco, California. The study on inhaled insulin compared the time to maximum blood insulin levels and time to maximum reduction in blood glucose between insulin delivered via inhalation and regular insulin delivered by subcutaneous injection in normal, fasting volunteers. In the study, each subject received inhaled insulin in two different settings, one while taking a deep breath and one while taking a more shallow breath. The time to maximum blood insulin levels and maximum blood glucose reduction were both significantly shorter after the deep breath than after either the more shallow breath or the subcutaneous injection. The AERx system includes unique, proprietary features that guide the patient to breathe correctly during delivery of insulin by inhalation. Diabetes treatment guidelines emphasize the importance of diabetics being able to predict how a given dose of insulin will affect their blood glucose levels. The differences in therapeutic effect brought on by differences in breathing that were observed in the study imply that controlling patients' breathing will be important in allowing diabetics to achieve reproducible delivery of inhaled insulin. Extensive clinical experience with currentasthma inhalers shows that patients are not able to learn and retain proper breathing techniques to achieve consistent delivery of inhaled drugs without continual feedback. Aradigm's AERx Diabetes Management System will provide the necessary feedback to help diabetics achieve reproducible delivery of inhaled insulin. Commenting on the clinical study, Richard P. Thompson, Aradigm's president and chief executive officer, said, "Inhaled insulin means fewer injections, and our data indicate that it may result in improved control over meal-time blood glucose levels. By making compliance with diabetes treatment guidelines easier, the AERx Diabetes Management System should lead to a major improvement in the quality of life for many people with diabetes." Located in Hayward, California, Aradigm is engaged in the development of novel, hand-held pulmonary drug delivery systems designed to enhance the delivery and effectiveness of a number of existing and development stage drugs and reduce the need for injectable drug therapy. Aradigm plans to commercialize its proprietary technologies on two product platforms; the SmartMist Asthma Management System, which is designed to improve the effectiveness of treatment provided by metered dose inhalers; and the AERx Pulmonary Drug Delivery System, which creates aerosols from liquid drug formulations for delivery locally to the lung or into the bloodstream via the lung.
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