Inhaled Human Insulin Treatment in Patients with Type 2 Diabetes Mellitus

  1. William T. Cefalu, MD;
  2. Jay S. Skyler, MD;
  3. Ione A. Kourides, MD;
  4. William H. Landschulz, MD, PhD;
  5. Cecile C. Balagtas, PhD;
  6. Shu-Lin Cheng, PhD;
  7. Robert A. Gelfand, MD; and
  8. for the Inhaled Insulin Study Group*
  1. From University of Vermont College of Medicine, Burlington, Vermont; University of Miami Medical Center, Miami, Florida; and Pfizer Central Research, Groton, Connecticut.

    Abstract

    Background: 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.

    Objective: To assess the efficacy and safety of pulmonary delivery of insulin in type 2 diabetic patients who require insulin.

    Design: Randomized, open-label, 3-month study consisting of a screening visit, a 4-week baseline lead-in phase, and a 12-week treatment phase.

    Setting: General clinical research center and outpatient research clinics.

    Patients: 26 patients (16 men, 10 women) with type 2 diabetes (average age, 51.1 years; average duration of diabetes, 11.2 years).

    Intervention: 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).

    Measurements: 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.

    Results: 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.

    Conclusions: 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.

    Article and Author Information

    • 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.

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    1. Ann Intern Med February 6, 2001 vol. 134 no. 3 203-207
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