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Young and Elderly Type 2 Diabetic Patients Inhaling Insulin with the AERx^® Insulin Diabetes Management System: A Pharmacokinetic and Pharmacodynamic Comparison

From the VA San Diego Healthcare System, Section of Diabetes/Endocrinology, San Diego, California (Dr. Henry, Dr. Mudaliar, Dr. Chu, Dr. Kim, Ms. Armstrong, Mr. Davis) and Novo Nordisk Pharmaceuticals, Inc., Princeton, New Jersey (Dr. An, Dr. Reinhardt).

The objective of this study was to compare the pharmacokinetics (PK), pharmacodynamics (PD), and safety of inhaled insulin delivered by the AERx^® iDMS in young and elderly patients with type 2 diabetes. Twenty-seven young (18-45 years, inclusive) and 28 elderly ( 65 years) type 2 diabetic patients were enrolled in this study. A single inhalation of 1.57 mg (45 IU, effect comparable to 6 s.c. units) of regular human insulin was administered to each patient on each of 2 dosing days, and blood samples were drawn up to 360 minutes postdosing to generate the PK/PD curves. AUC_{(0-360 min)} and C_max values of inhaled insulin were comparable between young and elderly subjects (p = 0.476 for AUC_{(0-360 min)} and p = 0.414 for C_max). However, the elderly group had significantly less glucose reduction, as indicated by plasma glucose AOC_(0-360) (area over the curve) values (p = 0.011). The intrasubject variability of inhaled insulin using the AERx^® iDMS was similar for young and elderly subjects and was similar to what has previously been reported for soluble insulin administered subcutaneously. Inhaled insulin was well tolerated in these patients, and no changes in pulmonary function tests were observed. A single inhalation of insulin using the AERx^® iDMS demonstrated comparable insulin PK profiles between the elderly and young type 2 patients but less glucose reduction in the elderly. Based on these results, elderly diabetic patients may need to inhale more insulin than young patients to achieve similar glycemic control. Long-term clinical trials using the AERx^® device will be useful to study age-related differences.

Key Words: Type 2 diabetes • pulmonary insulin delivery • AERx^® Insulin Diabetes Management System • pharmacokinetics • pharmacodynamics

Address for reprints: Robert R. Henry, MD, Section of Diabetes/Endocrinology, VA San Diego Healthcare System, 3350 La Jolla Village Dr. (111G), San Diego, CA 92161.

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