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| |  ADA CONFERENCE: Electronic Insulin Inhaler Shows Quick Reduction Of Blood Sugar CHICAGO, IL -- June 16, 1998 -- Clinical trial results, presented at the 58th annual scientific sessions of the American Diabetes Association, show that insulin delivered via Aradigm Corp.’s AERx(TM) Pulmonary Drug Delivery System is rapidly absorbed from the lung and reduces blood glucose faster than traditional injections. Furthermore, the studies showed that unlike injected insulin, higher concentrations of an inhaled insulin can be given without delaying the reduction in blood glucose. In a study presented today by principal investigator Aidan McElduff, MD, PhD, of North Shore Hospital in Sydney, Australia, the systemic absorption rates and resulting glycemic effect of regular human insulin (Eli Lilly and Co.’s Humulin(R)) was compared to pulmonary administration of the same compound with the AERx system. The study involved eleven healthy, fasting volunteers. Regardless of dosage strength (U250 or U500), inhaled insulin delivery with the AERx system resulted in a significantly faster time in achieving maximum glycemic effect as compared to subcutaneous insulin (approximately one hour with the AERx system versus about two hours with subcutaneous injection). In a related trial presented by Stephen Farr, PhD, senior director of pharmaceutical sciences at Aradigm Corp., the effectiveness of inhaled as compared to subcutaneous injection of the same fast-acting insulin analog (Lilly’s Humalog(R)) was studied in nine healthy males. Results showed that the time to maximum glucose effect was equivalent for inhaled versus subcutaneous administration (approximately 68 versus 72 minutes, respectively). The investigators concluded that the rapid reduction of blood glucose levels achieved by subcutaneous administration of Humalog also was achieved following pulmonary administration using the AERx system. According to the American Diabetes Association, diabetes affects 5.9 percent of the U.S. population. Of the nearly 16 million people with diabetes, 5.4 million people are not even aware they have the disease. Type II diabetes, the most common form of the disease, is expected to grow to epidemic proportions in the 21st century due to the aging baby boomer population and greater prevalence of obesity and sedentary lifestyles. Type II diabetes is caused by an impairment in the body's ability to efficiently manufacture, or properly use insulin. While the first line of disease management includes diet modification, weight loss and exercise, many patients eventually require daily insulin to manage their blood sugar levels.
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