Pulmonary function changes related to acute and chronic administration of inhaled insulin

Diabetes Technology and Therapeutics

Volumn 9, Issue SUPPL. 1, 2007, Pages

  Hegewald, Matthew ^a   Crapo, Robert O ^a   Jensen, Robert L ^b  

^a LDS HOSPITAL   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

CARBON MONOXIDE; HEMOGLOBIN A1C; INSULIN;

CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; DOSE TIME EFFECT RELATION; FORCED EXPIRATORY VOLUME; HUMAN; INSULIN DEPENDENCE; INSULIN TREATMENT; LONG TERM CARE; LUNG DIFFUSION CAPACITY; LUNG FUNCTION; META ANALYSIS; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT MONITORING; PATIENT SATISFACTION; POWDER INHALER; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SYSTEMATIC REVIEW; VITAL CAPACITY;

CARBON MONOXIDE; DIFFUSION; FORCED EXPIRATORY VOLUME; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; LUNG; RANDOMIZED CONTROLLED TRIALS; RESPIRATORY FUNCTION TESTS; VITAL CAPACITY;

EID: 34250749004     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/dia.2007.0209     Document Type: Conference Paper

References (42)

1. Centers for Disease Control and Prevention: National Diabetes Fact Sheet: General Information and National Estimates on Diabetes in the Unites States, 2005. Atlanta: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, 2005.
2. Saaddine JB, Engelgau MM, Beckles GL, Gregg EW, Thompson TJ, Narayan KM: A diabetes report card for the United States: quality of care in the 1990s. Ann Intern Med 2002;136:565-574.
3. Saaddine JB, Cadwell B, Gregg EW, Engelgau MM, Vinicor F, Imperatore G, Narayan KM: Improvements in diabetes processes of care and intermediate outcomes: United States, 1988-2002. Ann Intern Med 2006;144:465-474.
4. Muchmore DB, Gates JR: Inhaled insulin delivery - where are we now? Diabetes Obes Metab 2006;8:634-642.
5. Patton J: Mechanisms of macromolecule absorption by the lungs. Adv Drug Deliv Rev 1996;19:3-36.
6. Von Heubner W, De Jongh S: Uber inhalation von insulin. Klin Wochenschr 1924;51:2342-2343.
7. Wigley F, Londono J, Wood S, Shipp J, Waldman R: Insulin across respiratory mucosa by aerosol delivery. Diabetes 1971;20:552-556.
8. Rave K, Bott S, Heinemann L, Sha S, Becker RH, Willavize SA, Heise T: Time-action profile of inhaled insulin in comparison with subcutaneously injected insulin lispro and regular human insulin. Diabetes Care 2005;28:1077-1082.
9. Skyler JS, Cefalu WT, Kourides IA, Landschulz WH, Balagtas CC, Cheng SL, Gelfand RA.: Efficacy of inhaled human insulin in type 1 diabetes mellitus: a randomised proof-of-concept study. Lancet 2001;357:331-335.
10. Quattrin T, Belanger A, Bohannon NJ, Schwartz SL: 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 2004;27:2622-2627.
11. Skyler JS, Weinstock RS, Raskin P, Yale JF, Barrett E, Gerich JE, Gerstein HC; Inhaled Insulin Phase III Type 1 Diabetes Study Group: Use of inhaled insulin in a basal/bolus insulin regimen in type 1 diabetic subjects: a 6-month, randomized, comparative trial. Diabetes Care 2005;28:1630-1635.
12. Heise T, Bott S, Tusek C, Stephan JA, Kawabata T, Finco-Kent D, Liu C, Krasner A: The effect of insulin antibodies on the metabolic action of inhaled and subcutaneous insulin: a prospective randomized pharmacodynamic study. Diabetes Care 2005;28:2161-2169.
13. Garg S, Rosenstock J, Silverman BL, Sun B, Konkoy CS, de la Peña A, Muchmore DB: Efficacy and safety of preprandial human insulin inhalation powder versus injectable insulin in patients with type 1 diabetes. Diabetologia 2006;49:891-899.
14. Cappelleri JC, Cefalu WT, Rosenstock J, Kourides IA, Gerber RA: Treatment satisfaction in type 2 diabetes: a comparison between an inhaled insulin regimen and a subcutaneous insulin regimen. Clin Ther 2002;24:552-564.
15. Hermansen K, Ronnemaa T, Petersen AH, Bellaire S, Adamson U: Intensive therapy with inhaled insulin via the AERx insulin diabetes management system: a 12-week proof-of-concept trial in patients with type 2 diabetes. Diabetes Care 2004;27:162-167.
16. Hollander PA, Blonde L, Rowe R, Mehta AE, Milburn JL, Hershon KS, Chiasson JL, Levin SR: 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 2004;27:2356-2362.
17. Weiss SR, Cheng SL, Kourides IA, Gelfand RA, Landschulz WH: 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 2003;163:2277-2282.
18. Rosenstock J, Zinman B, Murphy LJ, Clement SC, Moore P, Bowering CK, Hendler R, Lan SP, Cefalu WT: Inhaled insulin improves glycemic control when substituted for or added to oral combination therapy in type 2 diabetes: a randomized, controlled trial. Ann Intern Med 2005;143:549-558.
19. DeFronzo RA, Bergenstal RM, Cefalu WT, Pullman J, Lerman S, Bode BW, Phillips LS; Exubera Phase III Study Group: Efficacy of inhaled insulin in patients with type 2 diabetes not controlled with diet and exercise: a 12-week, randomized, comparative trial. Diabetes Care 2005;28:1922-1928.
20. Barnett AH, Dreyer M, Lange P, Serdarevic-Pehar M: An open, randomized, parallel-group study to compare the efficacy and safety profile of inhaled human insulin (Exubera) with glibenclamide as adjunctive therapy in patients with type 2 diabetes poorly controlled on metformin. Diabetes Care 2006;29:1818-1825.
21. Barnett AH, Dreyer M, Lange P, Serdarevic-Pehar M: An open, randomized, parallel-group study to compare the efficacy and safety profile of inhaled human insulin (Exubera) with metformin as adjunctive therapy in patients with type 2 diabetes poorly controlled on a sulfonylurea. Diabetes Care 2006;29:1282-1287.
22. Freemantle N, Blonde L, Duhot D, Hompesch M, Eggertsen R, Hobbs FD, Martinez L, Ross S, Bolinder B, Stridde E: Availability of inhaled insulin promotes greater perceived acceptance of insulin therapy in patients with type 2 diabetes. Diabetes Care 2005;28:427-428.
23. Lange P, Parner J, Schnohr P, Jensen G: Copenhagen City Heart Study: longitudinal analysis of ventilatory capacity in diabetic and nondiabetic adults. Eur Respir J 2002;20:1406-1412.
24. Niranjan V, McBrayer DG, Ramirez LC, Raskin P, Hsia CC: Glycemic control and cardiopulmonary function in patients with insulin-dependent diabetes mellitus. Am J Med 1997;103:504-513.
25. Mori H, Okubo M, Okamura M, Yamane K, Kado S, Egusa G, Hiramoto T, Hara H, Yamakido M: Abnormalities of pulmonary function in patients with non-insulin-dependent diabetes mellitus. Intern Med 1992;31:189-193.
26. McKeever TM, Weston PJ, Hubbard R, Fogarty A: Lung function and glucose metabolism: an analysis of data from the Third National Health and Nutrition Examination Survey. Am J Epidemiol 2005;161:546-556.
27. Walter RE, Beiser A, Givelber RJ, O'Connor GT, Gottlieb DJ: Association between glycemic state and lung function: the Framingham Heart Study. Am J Respir Crit Care Med 2003;167:911-916.
28. Hsia CC, Raskin P: The diabetic lung: relevance of alveolar microangiopathy for the use of inhaled insulin. Am J Med 2005;118:205-211.
29. Schaafsma D, Gosens R, Ris JM, Zaagsma J, Meurs H, Nelemans SA: Insulin induces airway smooth muscle contraction. Br J Pharmacol 2007;150:136-142.
30. Leslie CC, McCormick-Shannon K, Robinson PC, Mason RJ: Stimulation of DNA synthesis in cultured rat alveolar type II cells. Exp Lung Res 1985;8:53-66.
31. Wadsworth SJ FA, Corteling RL, Hall IP: Biosynthesized matrix provides a key role for survival signaling in bronchial epithelial cells. Am J Physiol Lung Cell Mol Physiol 2004;286:L596-L603.
32. Aye M, Sheedy W, Harrison R, Thompson JS, Morice AH, Masson EA: Pulmonary vasodilation in the rat by insulin in vitro could indicate potential hazard for inhaled insulin. Diabetologia 2003;46:1199-1202.
33. Brain JD: Unlocking the opportunity of tight glycaemic control. Inhaled insulin: safety. Diabetes Obes Metab 2005;7(Suppl 1):S14-S18.
34. Ceglia L, Lau J, Pittas AG: Meta-analysis: efficacy and safety of inhaled insulin therapy in adults with diabetes mellitus. Ann Intern Med 2006;145:665-675.
35. Food and Drug Administration: Statistical Review and Evaluation: Clinical Studies; NDA: 21-868/N-000; Exubera (insulin [rDNA] INH powder). www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_02_06-FDA-Pulmonary-Safety. pdf (accessed January 26, 2007).
36. Teeter JG, Riese RJ: Dissociation of lung function changes with humoral immunity during inhaled human insulin therapy. Am J Respir Crit Care Med 2006;173:1194-1200.
37. Norwood P, Dumas R, Cefalu W, Yale JF, England R, Riese R: Randomized study to characterize glycemic control and short-term pulmonary function in patients with type 1 diabetes receiving inhaled human insulin (Exubera®). J Clin Endocrinol Metab 2006 Sep 26 [Epub ahead of print].
38. 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 monotherapy [abstract]. Diabetologia 2004;47(Suppl 1):A44.
39. Skyler JS: Sustained long-term efficacy and safety of inhaled insulin during 4 years of continuous therapy [abstract 486-P]. Diabetes 2004;53:A115.
40. Barnett AH: 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 [abstract]. Diabetes 2004;53:A107.
41. Advisory Committee Briefing Document: Exubera (insulin [rDNA origin] powder for oral inhalation). www.fda.gov/ohrms/dockets/ac/05/briefing/2005- 4169B1_01_01-Pfizer-Exubera.pdf on (accessed January 25, 2007).
42. Henry RR, Mudaliar SR, Howland WC 3rd, Chu N, Kim D, An B, Reinhardt RR: Inhaled insulin using the AERx Insulin Diabetes Management System in healthy and asthmatic subjects. Diabetes Care 2003;26:764-769.