Inhaled human insulin treatment in patients with type 2 diabetes mellitus

W. T. Cefalu, Jay S Skyler, I. A. Kourides, W. H. Landschulz, C. C. Balagtas, S. L. Cheng, R. A. Gelfand

Research output: Contribution to journalArticle

204 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)203-207+I54
JournalAnnals of Internal Medicine
Volume134
Issue number3
StatePublished - Feb 6 2001
Externally publishedYes

Fingerprint

Type 2 Diabetes Mellitus
Insulin
Therapeutics
Lung
Ultralente Insulin
Hemoglobins
Safety
Glucose
Injections
Respiratory Function Tests
Ambulatory Care Facilities
Research
Hypoglycemic Agents
Weight Gain
Meals

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Cefalu, W. T., Skyler, J. S., Kourides, I. A., Landschulz, W. H., Balagtas, C. C., Cheng, S. L., & Gelfand, R. A. (2001). Inhaled human insulin treatment in patients with type 2 diabetes mellitus. Annals of Internal Medicine, 134(3), 203-207+I54.

Inhaled human insulin treatment in patients with type 2 diabetes mellitus. / Cefalu, W. T.; Skyler, Jay S; Kourides, I. A.; Landschulz, W. H.; Balagtas, C. C.; Cheng, S. L.; Gelfand, R. A.

In: Annals of Internal Medicine, Vol. 134, No. 3, 06.02.2001, p. 203-207+I54.

Research output: Contribution to journalArticle

Cefalu, WT, Skyler, JS, Kourides, IA, Landschulz, WH, Balagtas, CC, Cheng, SL & Gelfand, RA 2001, 'Inhaled human insulin treatment in patients with type 2 diabetes mellitus', Annals of Internal Medicine, vol. 134, no. 3, pp. 203-207+I54.
Cefalu WT, Skyler JS, Kourides IA, Landschulz WH, Balagtas CC, Cheng SL et al. Inhaled human insulin treatment in patients with type 2 diabetes mellitus. Annals of Internal Medicine. 2001 Feb 6;134(3):203-207+I54.
Cefalu, W. T. ; Skyler, Jay S ; Kourides, I. A. ; Landschulz, W. H. ; Balagtas, C. C. ; Cheng, S. L. ; Gelfand, R. A. / Inhaled human insulin treatment in patients with type 2 diabetes mellitus. In: Annals of Internal Medicine. 2001 ; Vol. 134, No. 3. pp. 203-207+I54.
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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.",
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