Randomized study to characterize glycemic control and short-term pulmonary function in patients with type 1 diabetes receiving inhaled human insulin (exubera).

Authors:
Dr Paul Norwood, MD
Dr Paul Norwood, MD
University of California at San Francisco
Associate Clinical Professor of Medicine at UC San Francisco
Diabetes, cholesterol, hypertension,
Fresno, CA | United States
Richard Dumas
Richard Dumas
3330 Hospital Drive NW
Canada
William Cefalu
William Cefalu
Louisiana State University System
United States
Richard England
Richard England
LDS Hospital and University of Utah
United States
Richard Riese
Richard Riese
Brigham and Women's Hospital and Harvard Medical School
United States
John Teeter
John Teeter
Michigan State University
United States

J Clin Endocrinol Metab 2007 Jun 26;92(6):2211-4. Epub 2006 Sep 26.

University of California at San Francisco, Valley Research, Fresno, Ca 93720, USA.

Objective: Previous studies with inhaled human insulin [Exubera (EXU); insulin human (recombinant DNA origin) Inhalation Powder, Pfizer Inc., New York, NY; Nektar Therapeutics, San Carlos, CA) show comparable efficacy to sc insulin and small declines in pulmonary function in type 1 and 2 diabetes. This is a detailed characterization of short-term efficacy and pulmonary safety profile of EXU.

Research Design And Methods: In a 24-wk multicenter study, 226 nonsmoking patients with type 1 diabetes and normal lung function were randomized to intensive regimens of premeal EXU or sc insulin for 12 wk (comparative phase), followed by sc insulin for 12 wk (washout phase). Glycosylated hemoglobin, hypoglycemia, general adverse events, and pulmonary function were measured. Forced expiratory volume in 1 sec and carbon monoxide diffusion capacity were measured using standardized equipment and methodology.

Results: Comparable declines from baseline in glycosylated hemoglobin were observed in both groups (0.5%) and sustained throughout the study. There was a higher rate of hypoglycemia (risk ratio 1.23; 90% confidence interval 1.16, 1.30) but a lower rate of severe hypoglycemia (risk ratio 0.51; 90% confidence interval 0.30, 0.86) with EXU vs. sc insulin. The treatment group differences in changes from baseline in forced expiratory volume in 1 sec and carbon monoxide diffusion capacity were small, occurred within 2 wk of EXU initiation, and were reversible shortly after discontinuation. More patients reported mild cough with EXU vs. sc insulin (30.9% vs. 7.8%, respectively).

Conclusions: Three months of EXU therapy is as effective and well tolerated as intensive sc insulin therapy. This study supports the role of EXU in type 1 diabetes.

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http://dx.doi.org/10.1210/jc.2006-0631DOI Listing

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June 2007
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