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© 2005 by the American Diabetes Association, Inc.
Emerging Treatments and Technologies |
Time-Action Profile of Inhaled Insulin in Comparison With Subcutaneously Injected Insulin Lispro and Regular Human Insulin
1 Profil Institut für Stoffwechselforschung, Neuss, Germany
2 Pfizer Global Research and Development, Groton, Connecticut
3 Aventis Pharma Deutschland, Frankfurt, Germany
Address correspondence and reprint requests to Tim Heise, Profil Institut für Stoffwechselforschung GmbH, Hellersbergstr. 9, D-41460 Neuss, Germany. E-mail: tim.heise{at}profil-research.de
OBJECTIVE—This study compares the time-action profile of inhaled insulin (INH; Exubera) with that of subcutaneously injected insulin lispro (ILP) or regular human insulin (RHI) in healthy volunteers.
RESEARCH DESIGN AND METHODS—In this open-label, randomized, three-way, crossover study, 17 healthy male volunteers were given each of the following treatments in random order: INH (6 mg), ILP (18 units), or RHI (18 units). Glucose infusion rates and serum insulin concentrations were monitored over 10 h.
RESULTS—INH had a faster onset of action than both RHI and ILP, as indicated by shorter time to early half-maximal effect (32 vs. 48 and 41 min, respectively; P < 0.001 for IHN vs. RHI and P < 0.05 for IHN vs. ILP). Time to maximal effect was comparable between INH and ILP (143 vs. 137 min; NS) but was shorter for INH than RHI (193 min; P < 0.01). The maximal metabolic effect of INH was comparable with RHI but lower than ILP (8.7 vs. 9.8 vs. 11.2 mg · kg–1 · min–1, respectively; P < 0.01 for INH vs. ILP). The duration of action of INH, indicated by time to late half-maximal effect (387 min), was longer than ILP (313 min; P < 0.01) and comparable to RHI (415 min; NS). Total glucodynamic effect after inhalation of INH was comparable to both ILP and RHI (NS). Relative bioefficacy of INH was 10% versus RHI and 11% versus ILP. No drug-related adverse events were observed.
CONCLUSIONS—INH had a faster onset of action than RHI or ILP and a duration of action longer than ILP and comparable to RHI. These characteristics suggest that inhaled insulin is suitable for prandial insulin supplementation in patients with diabetes.
Abbreviations: AUC, area under the curve • FEV, forced expiratory volume • GIR, glucose infusion rate • ILP, insulin lispro • INH, inhaled insulin • RHI, regular human insulin.
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