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; Inhaled Insulin Study Group*
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. 2001;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.
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.
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Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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