A 6-month inhalation study to characterize the toxicity, pharmacokinetics, and pharmacodynamics of Human Insulin Inhalation Powder (HIIP) in beagle dogs

Journal of Aerosol Medicine: Deposition, Clearance, and Effects in the Lung

Volumn 20, Issue 2, 2007, Pages 112-126

  Vick, Andrew ^a   Wolff, Ronald ^b   Koester, Alan ^c   Reams, Rachel ^a   Deaver, Daniel R ^d   Heidel, Shawn ^a  

^a ELI LILLY AND COMPANY   (United States)

^b NEKTAR THERAPEUTICS   (United States)

^c BATTELLE MEMORIAL INSTITUTE   (United States)

^d ALKERMES INC   (United States)

Author keywords

HIIP; Insulin inhalation delivery; Pharmacodynamics; Pharmacokinetics; Toxicity

Indexed keywords

GLUCOSE; HUMAN INSULIN; PLACEBO;

AEROSOL; AIR QUALITY CONTROL; ANIMAL CELL; ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; BODY WEIGHT; CELL PROLIFERATION; CONTROLLED STUDY; DOG; DRUG ABSORPTION; DRUG ACCUMULATION; DRUG DOSE COMPARISON; DRUG FORMULATION; DRY POWDER; FEMALE; FOOD INTAKE; GLUCOSE BLOOD LEVEL; IMMUNOGENICITY; INSULIN BLOOD LEVEL; LUNG ALVEOLUS CELL; LUNG FUNCTION TEST; LUNG LAVAGE; MALE; MATHEMATICAL ANALYSIS; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; NONHUMAN; OPHTHALMOLOGY; PARTICLE SIZE; PHARMACODYNAMICS; RESPIRATORY FUNCTION; SEX DIFFERENCE;

ADMINISTRATION, INHALATION; ANIMALS; BLOOD GLUCOSE; DOGS; FEMALE; INSULIN; MALE; POWDERS; TREATMENT OUTCOME;

EID: 34249909753     PISSN: 08942684     EISSN: None     Source Type: Journal    
DOI: 10.1089/jam.2007.0586     Document Type: Article

References (19)

1. Cefalu, W.T. 2004. Concept, strategies, and feasibility of noninvasive insulin delivery. Diabetes Care 27:239-246.
2. Gansslen, M. 1925. About inhalation of insulin. Klin. Wochenschr. 4:71.
3. Patton, J.S., J. Bukar, and S. Nagarajan. 1999. Inhaled insulin. Adv. Drug Deliv. Rev. 35:235-247.
4. Wolff, R.K., and M.A. Dorato. 1993. Toxicologic testing of inhaled pharmaceutical aerosols. Crit. Rev. Toxicol. 23:343-369.
5. Lewis, T.R., P.F. Morrow, R.O. McClellan, O.G. Raabe, G.L. Kennedy, B.A. Schwetz, T.J. Goehl, J.H. Roycroft, and R.S. Chabra. 1989. Establishing aerosol concentrations for inhalation toxicology studies. Toxicol. Appl. Pharm. 99:377-383.
6. Duncan, J.R., K.W. Prasse, and E A. Mahaffey, eds. 1994. Veterinary Laboratory Medicine: Clinical Pathology. 3rd ed. Iowa State University Press, Ames, IA, 1994, 9, 112.
7. Cefalu, W.T., J.S. Skyler, I.A. Kourides, W.H. Landschulz, C.C. Balagtas, S.L. Cheng, and R.A. Gelfand. 2001. Inhaled insulin treatment in patients with type 2 diabetes mellitus. Ann. Intern. Med. 134:203-207.
8. Gopalakrishnan, V., P. Uster, G. Cow, and P. McDonald. 2001. Safety of inhaled insulin in dogs: a four week repeat dose study. [ISAM Congress] International Congress on Aerosols in Medicine (poster presentation).
9. Pillai, R.S., B.L. Hughes, R.K. Wolff, J.A. Heisserman, and M.A. Dorato. 1996. The effect of pulmonary-delivered insulin on blood glucose levels using two nebulizer systems. J. Aerosol. Med. 9:227-240.
10. Wolff, R.K., D.L. Allen, B.L. Hughes, H.W. Smith, J.Z. Chou, R.R. Bowsher, P.C. Francis, and J.L. Vahle. 2000. The case for route-dependent toxicology comparisons: using large animal models to speed clinical development of inhaled proteins. In R.N. Darby, P.R. Byron, S.J. Farr, and J. Peart, eds. Respiratory Drug Delivery VII. Serentec Press, Raleigh, NC. 163-170.
11. Heinemann, L., T. Traut, and T. Heise. 1997. Time-action profile of inhaled insulin. Diabetic Med. 14:63-72.
12. Fineberg, S.E. 2006. Diabetes therapy trials with inhaled insulin. Expert. Opin. Investig. Drugs 15:743-762.
13. Owens, D.O. 2002. New horizons - alternative routes for insulin therapy. Nat. Rev. Drug Discov. 1:529-540.
14. Bellary, S., and A.H. Barnett. 2006. Inhaled insulin: new technology, new possibilities. Int. J. Clin. Pract. 60:728-734.
15. Hollander, P.A., L. Blonde, R. Rowe, A.E. Mehta, J.L. Milburn, K.S. Hershon, J.L. Chiasson, and S.R. Levin. 2004. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with type 2 diabetes: results of a 6-month, randomized, comparative trial. Diabetes Care 27:2356-2362.
16. Quattrin, T., A. Belanger, N.J.V. Bohannon, and S.L. Schwartz. 2004. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with type 1 diabetes: results of a 6-month, randomized, comparative trial. Diabetes Care 27:2622-2627.
17. Skyler, J.S., R.S. Weinstock, P. Raskin, J.F. Yale, E. Barrett, J.E. Gerich, and H.C. Gerstein. 2005. Use of inhaled insulin in a basal/bolus insulin regimen in type 1 diabetic subjects: a 6-month, randomized, comparative trial. Diabetes Care 28:1630-1635.
18. Fineberg, S.E., T. Kawabata, D. Finco-Kent, C. Liu, and A. Krasner. 2005. Antibody response to inhaled insulin in patients with type 1 or type 2 diabetes. An analysis of initial phase II and III inhaled insulin (Exubera) trials and a two-year extension trial. J. Clin. Endocrinol. Metab. 90:3287-3294.
19. Patton, J.S. and R.M. Platz. 1994. Aerosol insulin: a brief review. In P.R. Bryon, ed. Respiratory Drug Delivery IV. Interpharm Press, Buffalo Grove, IL, pp 65-74.