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This version published online on September 26, 2006
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2006-0631
A more recent version of this article appeared on June 1, 2007
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Submitted on March 22, 2006
Accepted on September 19, 2006

Randomized Study to Characterize Glycemic Control and Short-Term Pulmonary Function in Patients with Type 1 Diabetes Receiving Inhaled Human Insulin (Exubera®)

Paul Norwood*, Richard Dumas, William Cefalu, Jean-francois Yale, Richard England, Richard Riese, and John Teeter for the Exubera® Phase 3 Study Group

University of California at San Francisco, Valley Research, Fresno, CA, USA; Laval Clinical Research Center, Quebec, Canada; Pennington Biomedical Research Center, Baton Rouge, LA, USA; McGill Nutrition and Food Science Center, Montreal, Quebec, Canada; Pfizer Global Research and Development, Groton, CT, USA

* To whom correspondence should be addressed. E-mail: norwood{at}pol.net.

OBJECTIVE: Previous studies with inhaled human insulin (INH; Exubera®; (insulin human [rDNA origin]) Inhalation Powder) show comparable efficacy to sc insulin and small declines in pulmonary function in type 1 or 2 diabetes. This is a detailed characterization of efficacy and short-term pulmonary safety profile of INH.

RESEARCH DESIGN AND METHODS: In a 24-week multicenter study, 226 nonsmoking patients with type 1 diabetes and normal lung function were randomized to premeal INH or SC insulin for 12 weeks (comparative phase), followed by SC insulin for 12 weeks (washout phase). HbA1c was the primary efficacy end point. Pulmonary function testing was performed using standardized equipment, trained coordinators, and centralized data collection.

RESULTS: Comparable declines from baseline in HbA1c were observed in both groups (0.5%) and sustained throughout the study. Treatment group differences in pulmonary function were small, occurred within 2 weeks, and were nonprogressive (FEV1 data with 90% CIs: -0.043 [-0.075, -0.011], -0.09 [-0.041, 0.023], 0.041 [0.007, 0.076], and 0.014 [-0.021, 0.049] at Weeks 2, 12, 14, and 24, respectively). There was a higher incidence of mild cough with INH (30.9%) vs. SC (7.8%). There was no association between insulin antibodies with INH and pulmonary function.

CONCLUSION: Three months of INH therapy is as effective and well tolerated as intensive SC insulin therapy. Small, clinically insignificant treatment group differences favoring SC treatment occurred within the first few weeks of the comparative phase and resolved following discontinuation. This study supports the role of INH in type 1 diabetes.
Key words: Glycemic control • inhaled human insulin • Exubera® • pulmonary function • type 1 diabetes




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