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Two-Year Pulmonary Safety and Efficacy of Inhaled Human Insulin (Exubera) in Adult Patients With Type 2 Diabetes

¹ Dallas Diabetes and Endocrine Center, Dallas, Texas
² Pennington Biomedical Research Center, Baton Rouge, Louisiana
³ Baylor University Medical Center, Dallas, Texas
⁴ Cité de la Santé Hospital, Laval, Quebec, Canada
⁵ Hospital Albert Einstein, São Paulo, São Paulo, Brazil
⁶ Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
⁷ Pfizer Global Research and Development, New London, Connecticut
⁸ Pfizer Global Research and Development, Ann Arbor, Michigan

Corresponding author: Julio Rosenstock, juliorosenstock{at}dallasdiabetes.com

OBJECTIVE—The purpose of this study was to evaluate the 2-year pulmonary safety of inhaled human insulin (Exubera [EXU]) in 635 nonsmoking adults with type 2 diabetes.

RESEARCH DESIGN AND METHODS—Patients were randomly assigned to receive prandial EXU or subcutaneous insulin (regular or short-acting) plus basal (intermediate- or long-acting) insulin. The primary end points were the annual rate of decline in forced expiratory volume in 1 s (FEV₁) and carbon monoxide diffusing capacity (DL_CO).

RESULTS—Small differences in FEV₁ favoring subcutaneous insulin developed during the first 3 months but did not progress. Adjusted treatment group differences in FEV₁ annual rate of change were –0.007 l/year (90% CI –0.021 to 0.006) between months 0 and 24 and 0.000 l/year (–0.016 to 0.016) during months 3–24. Treatment group differences in DL_CO annual rate of change were not significant. Both groups sustained similar reductions in A1C by month 24 (last observation carried forward) (EXU 7.7–7.3% vs. subcutaneous insulin 7.8–7.3%). Reductions in fasting plasma glucose (FPG) were greater with EXU than with subcutaneous insulin (adjusted mean treatment difference –12.4 mg/dl [90% CI –19.7 to –5.0]). Incidence of hypoglycemia was comparable in both groups. Weight increased less with EXU than with subcutaneous insulin (–1.3 kg [–1.9 to –0.7]). Adverse events were comparable, except for a higher incidence of mild cough and dyspnea with EXU.

CONCLUSIONS—Two-year prandial EXU therapy showed a small nonprogressive difference in FEV₁ and comparable sustained A1C improvement but lower FPG levels and less weight gain than seen in association with subcutaneous insulin in adults with type 2 diabetes.

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