William T. Cefalu, MD; Jay S. Skyler, MD; Ione A. Kourides, MD; William H. Landschulz, MD, PhD; Cecile C. Balagtas, PhD; Shu-Lin Cheng, PhD; Robert A. Gelfand, MD; for the Inhaled Insulin Study Group*
Presented in abstract form as an oral presentation at the Annual Meeting of the American Diabetes Association, Chicago, Illinois, June 1998.
Acknowledgment: The authors thank Becky Aksdal for her skillful preparation of the manuscript and her valuable editorial assistance.
Grant Support: By Pfizer, Inc. Technology used for this study was licensed from Inhale Therapeutic Systems, San Carlos, California.
Requests for Single Reprints: William T. Cefalu, MD, University of Vermont College of Medicine, UHC Campus, Arnold 3433, One South Prospect Street, Burlington, VT 05401.
Current Author Addresses: Dr. Cefalu: University of Vermont College of Medicine, UHC Campus, Arnold 3433, One South Prospect Street, Burlington, VT 05401.
Dr. Skyler: University of Miami Medical Center, 1500 NW 12th Avenue, Suite 1012 East, Miami, FL 33136.
Dr. Kourides: Clinical and Scientific Affairs, Pfizer, Inc., 235 East 42nd Street, New York, NY 10017.
Drs. Landschulz and Gelfand: Department of Clinical Research, Pfizer, Inc., Eastern Point Road, Groton, CT 06340-8030.
Drs. Balagtas and Cheng: Department of Biometrics and Data Management, Pfizer, Inc., Eastern Point Road, Groton, CT 06340.
Author Contributions: Conception and design: I.A. Kourides, W.H. Landschulz, R.A. Gelfand.
Analysis and interpretation of the data: W.T. Cefalu, J.S. Skyler, I.A. Kourides, W.H. Landschulz, C.C. Balagtas, S.-L. Cheng, R.A. Gelfand.
Drafting of the article: W.T. Cefalu, I.A. Kourides, W.H. Landschulz, C.C. Balagtas, S.-L. Cheng, R.A. Gelfand.
Critical revision of the article for important intellectual content: W.T. Cefalu, J.S. Skyler, I.A. Kourides, W.H. Landschulz, C.C. Balagtas, R.A. Gelfand.
Final approval of the article: W.T. Cefalu, J.S. Skyler, I.A. Kourides, W.H. Landschulz, C.C. Balagtas, R.A. Gelfand.
Provision of study materials or patients: J.S. Skyler, W.H. Landschulz, R.A. Gelfand.
Statistical expertise: C.C. Balagtas, S.-L. Cheng.
Obtaining of funding: R.A. Gelfand.
Administrative, technical, or logistic support: W.H. Landschulz, R.A. Gelfand.
Collection and assembly of data: W.T. Cefalu, W.H. Landschulz, C.C. Balagtas, R.A. Gelfand.
Despite demonstrated benefits, intensive insulin therapy has not gained widespread clinical acceptance for several reasons: Multiple daily injections are inconvenient, adherence is a concern, and the time-activity profile may not mimic normal insulin secretion. As such, alternate means of administering insulin are being evaluated.
To assess the efficacy and safety of pulmonary delivery of insulin in type 2 diabetic patients who require insulin.
Randomized, open-label, 3-month study consisting of a screening visit, a 4-week baseline lead-in phase, and a 12-week treatment phase.
General clinical research center and outpatient research clinics.
26 patients (16 men, 10 women) with type 2 diabetes (average age, 51.1 years; average duration of diabetes, 11.2 years).
Patients received inhaled insulin before each meal plus a bedtime injection of ultralente insulin, performed home glucose monitoring, and had weekly adjustment of insulin dose; target level for preprandial plasma glucose was 5.55 to 8.88 mmol/L (100 to 160 mg/dL).
Glycemic control (hemoglobin A1c level) obtained at baseline and monthly for 3 months. Pulmonary function tests were done at baseline and at the end of the study.
Inhaled insulin treatment for 3 months significantly improved glycemic control compared with baseline: Mean hemoglobin A1c levels decreased by 0.0071 ± 0.0072 (0.71% ± 0.72%). Patients experienced an average of 0.83 mild to moderate hypoglycemic event per month; no severe events were recorded. Patients showed no significant weight gain or change in pulmonary function compared with baseline.
Pulmonary delivery of insulin in type 2 diabetic patients who require insulin improved glycemic control, was well tolerated, and demonstrated no adverse pulmonary effects. Larger-scale studies are ongoing to provide long-term efficacy and safety data.
*For members of the Inhaled Insulin Study Group, see Appendix.
Cefalu WT, Skyler JS, Kourides IA, Landschulz WH, Balagtas CC, Cheng S, et al. Inhaled Human Insulin Treatment in Patients with Type 2 Diabetes Mellitus. Ann Intern Med. ;134:203–207. doi: 10.7326/0003-4819-134-3-200102060-00011
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Published: Ann Intern Med. 2001;134(3):203-207.
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism.
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