Clinical evaluation of inhaled insulin

Advanced Drug Delivery Reviews

Volumn 58, Issue 9-10, 2006, Pages 1061-1075

  Mastrandrea, Lucy D ^a   Quattrin, Teresa ^a  

^a UNIVERSITY AT BUFFALO   (United States)

Author keywords

Diabetes; Drug administration routes; Glycemic control; Hemoglobin A1c; Inhalation; Insulin; Insulin administration; Lung; Type 1 diabetes; Type 2 diabetes

Indexed keywords

DIAGNOSIS; DISEASES; HEMOGLOBIN; MEDICAL APPLICATIONS; PATIENT TREATMENT;

DIABETES; GLYCEMIC CONTROL; HEMOGLOBIN A1C; INHALATION; INSULIN ADMINISTRATION; LUNGS; TYPE 1 DIABETES; TYPE 2 DIABETES;

INSULIN;

BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; INSULIN; INSULIN DERIVATIVE; METFORMIN; SULFONYLUREA;

AGING; ALLERGIC REACTION; ASTHMA; CLINICAL TRIAL; DEVICE; DISEASE EXACERBATION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG SAFETY; ECONOMIC ASPECT; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; LUNG FUNCTION; METERED DOSE INHALER; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SATISFACTION; PHARMACOLOGICAL PARAMETERS; PRIORITY JOURNAL; RESPIRATORY TRACT INFECTION; REVIEW; SIDE EFFECT; SMOKING; WEIGHT GAIN;

ADMINISTRATION, INHALATION; DIABETES MELLITUS; DRUG DELIVERY SYSTEMS; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; LUNG; NEBULIZERS AND VAPORIZERS;

EID: 33751233271     PISSN: 0169409X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.addr.2006.07.019     Document Type: Review

References (83)

1. Kaufman F.R. Type 2 diabetes in children and youth. Endocrinol. Metab. Clin. N. Am. 34 (2005) 659-676
2. Bliss M. The Discovery of Insulin (1982), University of Chicago Press
3. DCCT Research Group. Diabetes Control and Complication (DCCT). N. Engl. J. Med. 329 (1993)
4. U.P.D.S.U. Group. UK Prospective Diabetes Study, VIII, Study design, progress and performance. Diabetologia 34 (1991) 877
5. Turner R., Cull C., and Holman R. United Kingdom Prospective Diabetes Study: a 9-year update of a randomized controlled trial on the effect of improved metabolic control on complications in non-insulin-dependent diabetes mellitus. Ann. Intern. Med. 124 1 pt 2 (1996) 837
6. Stratton I.M., Adler A.I., Neil H.A.W., et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. Br. Med. J. 321 (2000) 405
7. Zambanini A., Newson R.B., Maisey M., and Feher M.D. Injection related anxiety in insulin-treated diabetes. Diabetes Res. Clin. Pract. 46 (1999) 239-246
8. Ferraresi V. Inhaled opioids for the treatment of dyspnea. Am. J. Health-Syst. Pharm. 62 (2005) 319-320
9. Heubner W., De Jongh S., and Laquer E. Uber Inhalation Von Insulin. Klin. Wochenschr. 3 (1924)
10. Katz I.M., Schroeter J.D., and Martonen T.B. Factors affecting the deposition of aerosolized insulin. Diabetes Technol. Ther. 3 (2001) 387-397
11. Klonoff D.C. Inhaled insulin. Diabetes Technol. Ther. 1 (1999) 307-313
12. Edwards D.A., Hanes J., Caponetti G., Hrkach J., Ben-Jebria A., Eskew M.L., Mintzes J., Deaver D., Lotan N., and Langer R. Large porous particles for pulmonary drug delivery. Science 276 (1997) 1868-1871
13. Lenzer J. Inhaled insulin is approved in Europe and United States. BMJ 332 (2006) 321
14. Farr S.J., Warren S.J., Lloyd P., Okikawa J.K., Schuster J.A., Rowe A.M., Rubsamen R.M., and Taylor G. Comparison of in vitro and in vivo efficiencies of a novel unit - dose liquid aerosol generator and a pressurized metered dose inhaler. Int. J. Pharm. 198 (2000) 63-70
15. Morimoto K., Yamahara H., Lee V.H., and Kim K.J. Transport of thyrotropin-releasing hormone across rat alveolar epithelial cell monolayers. Life Sci. 54 (1994) 2083-2092
16. Forbes B., Wilson C., and Gumbleton M. Temporal dependence of ectopeptidase expression in alveolar epithelial cell culture, applications for the study of peptide absorption. Int. J. Pharm. 180 (1999) 225-234
17. Elliott R.B., Edgar B.W., Pilcher C.C., Quested C., and McMaster J. Parenteral absorption of insulin from the lung in diabetic children. Aust. Paediat. J. 23 (1987) 293-297
18. Sakagami M. Insulin disposition in the lung following oral inhalation in humans; a meta-analysis of its pharmacokinetics. Clin. Pharmacokinet. 43 (2004) 539-552
19. Edwards D.A., and Dunbar C. Bioengineering of therapeutic aerosols. Annu. Rev. Biomed. Eng. 4 (2002) 93-107
20. Isaacs K.K., and Martonen T.B. Particle deposition in children's lungs: theory and experiment. J. Aerosol. Med. 18 (2005) 337-353
21. Feddah M.R., Brown K.F., Gipps E.M., and Davies N.M. In-vitro characterization of metered-dose inhaler versus dry powder inhaler glucocorticoid products: influence of inspiratory flow rates. J. Pharaceut. Sci. 3 (2000) 317-324
22. Usmani O.S., Biddiscombe M.F., and Barnes P.J. Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am. J. Respir. Crit. Care Med. 172 (2005) 1497-1504
23. Farr S.J., McElduff A., Mather L.E., Okikawa J., Ward M.E., Gonda I., Licko V., and Rubsamen R.M. Pulmonary insulin administration using the AERx System: physiological and physicochemical factors influencing insulin effectiveness in healthy fasting subjects. Diabetes Technol. Ther. 2 (2000) 185-197
24. Deshpande D.S., Blanchard J.D., Schuster J., Fairbanks D., Hobbs C., Beihn R., Densmore C., Farr S., and Gonda I. Gamma scintigraphic evaluation of a miniaturized AERx pulmonary delivery system for aerosol delivery to anesthetized animals using a positive pressure ventilation system. J. Aerosol. Med. 18 (2005) 34-44
25. Anonymous. Insulin inhalation-Pfizer/Nektar Therapeutics: HMR 4006, inhaled PEG-insulin. Drugs R&D 5 (2004) 166-170
26. Harsch I.A. Inhaled insulins: their potential in the treatment of diabetes mellitus. Treat. Endocrinol. 4 (2005) 131-138
27. Cefalu W.T., Skyler J.S., Kourides I.A., Landschulz W.H., Balagtas C.C., Cheng S., and Gelfand R.A. Inhaled human insulin treatment in patients with type 2 diabetes mellitus. Ann. Intern. Med. 134 (2001) 203-207
28. Exubera medication guide (2006,). http://www.fda.gov/cder/foi/label/2006/021868mg.pdf http://www.fda.gov/cder/foi/label/2006/021868mg.pdf
29. Brunner G.A., Balent B., Ellmerer M., Schaupp L., Siebenhofer A., Jendle J.H., Okikawa J., and Pieber T.R. Dose-response relation of liquid aerosol inhaled insulin in type 1 diabetic patients. Diabetologia 44 (2001) 305-308
30. Henry R.R., Mudaliar S.R., Howland III W.C., Chu N., Kim D., An B., and Reinhardt R.R. Inhaled insulin using the AERx insulin diabetes management system in healthy and asthmatic subjects. Diabetes Care 26 (2003) 764-769
31. Anonymous. Pulmonary Medicine: Novo Nordisk, Aradigm start phase III studies of AERx Insulin Delivery System. Diabetes Week (2002) 15
32. Hrkach J., Batycky R., Chen D., Deaver D., Elbert K., Johnston L., Kovalesky M., Nice J., Schmitke J., Stapleton K., and Edwards D. Air Insulin: complete diabetes therapy via inhalation of fast-acting and slow-acting dry powder aerosols. Diabetes 49 (2000) A9 (Abstract)
33. Hayes R.P., Rosenstock J., Muchmore D.B., Stump T.E., and Silverman B. Patient reported outcomes (Pros) using the Lilly/Alkermes inhaled insulin system versus injectable insulin in patients with type 1 diabetes (T1D). EASD Preview, Summer Street Research Partners (2005) p. 9 of 12
34. Boss A.H., Cheatham W.W., Rave K., and Heise T. Markedly reduced postprandial glucose excursions through inhaled Technosphere/Insulin in comparison to SC injected regular insulin in subjects with type 2 diabetes. EASD Previews, Summer Street Research Partners (2005) p. 10 of 12
35. Rosenstock J., Baughman R.A., Rivera-Schaub T., Otterbach K., Donigi-Gale D., Thibault J., Tomiak M., Sheng K., Boss A., and Cheatham W. A randomized, double-blind, placebo controlled study of the efficacy and safety of inhaled Technosphere insulin in patients with type 2 diabetes (T2DM). Diabetes 54 (2005)
36. Muchmore D.B., Nosek L., de la Pena A., Segar M., Ernest II C.S., Heinemann L., Batycky R., and Rave K. Dose response of human insulin inhalation powder (HIIP) and dose equivalence to subcutaneous (SC) insulin lispro. EASD Preview, Summer Street Research Partner (2005) p. 11 of 12
37. Hausmann M., Dellweg S., Heinemann L., Buchwald A., and Heise T. Add-on therapy with Kos inhaled insulin is as efficacious as add-on therapy with Lantus in poorly controlled type 2 diabetic patients treated with sulfonlyureas or metformin. EASD Preview, Summer Street Research Partner (2005) p. 8 of 12
38. Byron P.R., and Patton J.S. Drug delivery via the respiratory tract. J. Aerosol. Med. 7 (1994) 49-75
39. Ahrens R.C., and Smith G.D. Albuterol: an adrenergic agent for use in the treatment of asthma pharmacology, pharmacokinetics and clinical use. Pharmacotherapy 4 (1984) 105-121
40. Hoshino M., Nakamura Y., Sim J.J., Yamashiro Y., Uchida K., Hosaka K., and Isogai S. Inhaled corticosteroid reduced lamina reticularis of the basement membrane by modulation of insulin-like growth factor (IGF)-I expression in bronchial asthma. Clin. Exp. Allergy 28 (1998) 568-577
41. Chan H.K., Daviskas E., Eberl S., Robinson M., Bautovich G., and Young I. Deposition of aqueous aerosol of technetium-99 m diethylene triamine penta-acetic acid generated and delivered by a novel system (AERx) in healthy subjects. Eur. J. Nucl. Med. 26 (1999) 320-327
42. Rave K., Bott S., Heinemann L., Sha S., Becker R.H., Willavize S.A., and Heise T. Time-action profile of inhaled insulin in comparison with subcutaneously injected insulin lispro and regular human insulin. Diabetes Care 28 (2005) 1077-1082
43. Patton J.S., Bukar J.G., and Eldon M.A. Clinical pharmacokinetics and pharmacodynamics of inhaled insulin. Clin. Pharmacokinet. 43 (2004) 781-801
44. Kapitza C., Hompesch M., Scharling B., and Heise T. Intrasubject variability of inhaled insulin in type 1 diabetes: a comparison with subcutaneous insulin. Diabetes Technol. Ther. 6 (2004) 466-472
45. Boss A., Heise T., Rave K., and Cheatham W. The variability and time-action profile of inhaled Technosphere/Insulin compares favorably to that of subcutaneous human regular insulin. Diabetes 54 (2005) A88
46. Petersen A.H., Plank J., Bock G., Wutte A., Haahr H., Ronn B., and Pieber T.R. Onset of action of inhaled via the AERx IDMS was faster than subcutaneous human regular insulin and similar to that of subcutaneous insulin aspart. Diabetes 54 (2005) A88
47. Quattrin T., Belanger A., Bohannon N.J., and Schwartz S.L. 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 (2004) 2622-2627
48. Skyler J.S., Cefalu W.T., Kourides I.A., Landschulz W.H., Balagtas C.C., Cheng S.L., and Gelfand R.A. Efficacy of inhaled human insulin in type 1 diabetes mellitus: a randomized proof-of-concept study. Lancet 357 (2001) 331-335
49. Belanger A. Efficacy and safety of inhaled insulin (Exubera) compared to subcutaneous insulin therapy in patients with type 2 diabetes: results of a 6-month, randomized, comparative trial. EASD 38 (2002) A260-A261
50. McElduff A., Clauson P., Uy C., Kam P., and Mather L.E. Pulmonary absorption profiles of insulin during and after an upper respiratory tract infection in healthy volunteers using the AERx Insulin Diabetes Management System. An open labeled cross-over study in healthy volunteers vol. 51 (2) (2002) A107
51. McElduff A., Mather L.E., Kam P.C., and Clauson P. Influence of acute upper respiratory tract infection on the absorption of inhaled insulin using the AERx Insulin Diabetes Management System. Br. J. Clin. Pharmacol. 59 (2005) 546-551
52. Henry R.R., Mudaliar S.R., Howland III W.C., Chu N., Kim D., An B., and Reinhardt R.R. Inhaled insulin using the AERx Insulin Diabetes Management System in healthy and asthmatic subjects. Diabetes Care 26 (2003) 764-769
53. Haire-Joshu D., Glasgow R., and Tibbs T. Smoking and diabetes. Diabetes Care 22 (1999) 1887-1898
54. Himmelmann A., Jendle J., Mellen A., Petersen A.H., Dahl U.L., and Wollmer P. The impact of smoking on inhaled insulin. Diabetes Care 26 (2003) 677-682
55. Chiodera P., Volpi R., Capretti L., Speroni G., Necchi-Ghiri S., Caffarri G., Colla R., and Coiro V. Abnormal effect of cigarette smoking on pituitary hormone secretions in insulin-dependent diabetes mellitus. Clin. Endocrinol. (Oxf.) 46 (1997) 351-357
56. Pan A., Chan C., Loh M.T., Yeo K.P., Muchmore D., Silverman B., De La Pena A., and Wise S. Effects of smoking (immediate and delayed), abstinence, nicotine replacement therapy and smoking resumption on pulmonary insulin pharmacokinetics and glucodynamics. Diabetes 53 (2004) A112
57. Knudson R.J.e.a. A descriptive agalysis of the growth and decline of the FVC and FEV1. Chest 83 (1983) 717-724
58. Henry R.R., Mudaliar S., Chu N., Kim D., Armstrong D., Davis T.T., An B., and Reinhardt R.R. Young and elderly type 2 diabetic patients inhaling insulin with the AERx Insulin Diabetes Management System: a pharmacokinetic and pharmacodynamic comparison. J. Clin. Pharmacol. 43 (2003) 1228-1234
59. Royle P., Waugh N., McAuley L., McIntyre L., and Thomas S. Inhaled insulin in diabetes mellitus. Cochrane Database Syst. Rev. (2004) CD003890
60. Skyler J.S., Weinstock R.S., Raskin P., Yale J.F., Barrett E., Gerich J.E., and Gerstein H.C. Use of inhaled insulin in a basal/bolus insulin regimen in type 1 diabetic subjects. Diabetes Care 28 (2005) 1630-1635
61. Skyler J.S. Efficacy and safety of inhaled insulin (Exubera) compared to subcutaneous insulin therapy in an intensive insulin regimen in patients with type 1 diabetes: results of a 6-month, randomized, comparative trial. Diabetes 51 (2002) A135
62. Quattrin T. Efficacy and Safety of Inhaled Insulin (Exubera) compared to conventional subcutaneous insulin therapy in patients with type 1 diabetes: results of a 6-month, randomized, comparative trial. EASD 38 (2002) A261
63. Cefalu W.T., Lan S., Gelfand R.A., and Landschulz W.H. The inhaled insulin phase II study group: sustained long-term efficacy and pulmonary safety of inhaled dry powder insulin. Am. J. Respir. Crit. Care 163 (2001) A163
64. Hollander P.A., Blonde L., Rowe R., Mehta A.E., Milburn J.L., Hershon K.S., Chiasson J.L., and Levin S.R. 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 (2004) 2356-2362
65. Barnett A.H. Efficacy and one-year pulmonary safety of inhaled insulin (Exubera) as adjunctive therapy with metformin or glibenclamide in type 2 diabetes patients poorly controlled on oral agent monotherapy. Diabetes 53 (2004) A107
66. Weiss S.R., Cheng S.L., Kourides I.A., Gelfand R.A., and Landschulz W.H. Inhaled insulin provides improved glycemic control in patients with type 2 diabetes mellitus inadequately controlled with oral agents: a randomized controlled trial. Arch. Intern. Med. 163 (2003) 2277-2282
67. Rosenstock J., Zinman B., Murphy L.F., Clement S.C., Moore P., Bowering C.K., Hendler R., Lan S., and Cefalu W.T. Inhaled insulin improves glycemic control when substituted for or added to oral combination therapy in type 2 diabetes. Ann. Int. Med. 143 (2005) 549-558
68. Rosenstock J., and Riddle M. Insulin Therapy in Type 2 Diabetes (2004), Medical Information Pr, New York 145-168
69. Porte Jr. D., Sherwin R.S., and Baron A. Ellenberg and Rifkin's Diabetes Mellitus (2003), McGraw-Hill, New York
70. Burgering B.M., Pronk G.J., Medema J.P., van der Boorn L., de Vries Smits A.M., van Weeren P.C., and Bos J.L. Role of p21ras in growth factor signal transduction. Biochem. Soc. Trans. 221 (1993) 888-894
71. Norwood P., England R.D., Riese R.J., and Teeter J.G. Inhaled insulin (Exubera) achieves tight glycemic control and is well tolerated in patients with type 1 diabetes. EASD Preview, Summer Street Research Partners (2005) p. 8 of 12
72. Dreyer M. Efficacy and two-year pulmonary safety of inhaled insulin as adjunctive therapy with metformin or glibenclamide in type 2 diabetes patients poorly controlled with oral therapy. Diabetologia 47 (2004) A44
73. Skyler J.S. Sustained long-term efficacy and safety of inhaled insulin during 4 years of continuous therapy. Diabetes 53 (2004) A115
74. Wolff R.K. Safety of inhaled proteins for therapeutic use. J. Aerosol Med. 11 (1998) 197-219
75. Salvi S., and Holgate S.T. Mechanisms of particulate matter toxicity. Clin. Exp. Allergy 29 (1999) 1187-1194
76. Schernthaner G. Immunogenicity and allergenic potential of animal and human insulins. Diabetes Care 16 (1993) 155-165
77. Fineberg S.E., Kawabata T., Finco-Kent D., Liu C., and Krasner A. Antibody response to inhaled insulin in patients with type 1 or type 2 diabetes. J. Clin. Endocrinol. Metab. (2005)
78. Bilous R. Overall satisfaction increased more with inhaled insulin than with subcutaneous insulin in type 1 diabetes. ACP J. Club 136 (2002) 101
79. Rosenstock J., Cappelleri J.C., Bolinder B., and Gerber R.A. Patient satisfaction and glycemic control after 1 year with inhaled insulin (Exubera) in patients with type 1 or type 2 diabetes. Diabetes Care 27 (2004) 1318-1323
80. Freemantle N., Blonde L., Duhot D., Hompesch M., Eggertsen R., Hobbs F.D., Martinez L., Ross S., Bolinder B., and Stridde E. Availability of inhaled insulin promotes greater perceived acceptance of insulin therapy in patients with type 2 diabetes. Diabetes Care 28 (2005) 427-428
81. Cramer J.A., Okikawa J., Bellaire S., and Clauson P. Compliance with inhaled insulin treatment using the AERx IDMS Insulin Diabetes Management System. Diabetes Technol. Ther. 6 (2004) 800-807
82. Clarke P.M., Gray A.M., Briggs A., Stevens R.J., Matthews D.R., and Holman R.R. Cost-utility analyses of intensive blood glucose and tight blood pressure control in type 2 diabetes (UKPDS 72). Diabetologia 48 (2005) 868-877
83. V. B. Kennedy, Drug rivals to vie for share of inhaled-insulin market. In, Vol. 2005, www.investors.com, 2005.