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SUMMARY

  • • The need for noninvasive insulin is clear.
  • • More than 100 clinical trials conducted over the past 25 years in many thousands of patients over years of exposure have provided a level of comfort for the safety and efficacy of inhaled insulin across a variety of delivery devices and formulations.
  • • The case for making inhaled insulin available to patients suffering from diabetes remains more compelling than ever.
  • • The key challenges for introducing a commercially successful inhaled insulin product are to develop
  • • A device that is equally reliable as the first-generation devices, but smaller, more discrete, and easier to use
  • • An insulin formulation that is equally safe and even more comfortable for daily inhalation
  • • A product that is robust and inexpensive to manufacture at high scale

REFERENCES

  • 1. http://www.idf.org/diabetesatlas/.
  • 2. http://www.bccresearch.com/market-research/healthcare/insulin-drug-delivery- devices-hlc149a.html.
  • 3. http://diabetes.niddk.nih.gov/dm/pubs/statistics/#Treatment.
  • 4. Hauber AB, Johnson FR, Sauriol L, Lescrauwaet B. Risking health to avoid injections: Preferences of Canadians with type 2 diabetes. Diabetes Care, 28(9):2243-2245 (2005).
  • 5. Peyrot M, Rubin RR, Khunti K. Addressing barriers to initiation of insulin in patients with type 2 diabetes. Prim Care Diabetes, 4(Suppl. 1):S11-S18 (2010).
  • 6. Peyrot M et al. Resistance to insulin therapy among patients and providers: Results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care, 28(11):2673-2679 (2005).
  • 7. Polonsky WH, Fisher L, Guzman S, Villa-Caballero L, Edelman SV. Psychological insulin resistance in patients with type 2 diabetes: The scope of the problem. Diabetes Care, 28(10):2543-2545 (2005).
  • 8. Zambanini A, Newson RB, Maisey M, Feher MD. Injection related anxiety in insulin- treated diabetes. Diabetes Res Clin Pract, 46(3):239-246 (1999).
  • 9. Ismail-Beigi F. Clinical practice: Glycemic management of type 2 diabetes mellitus. N Engl J Med, 366(14):1319-1327 (2012).
  • 10. Nathan DM et al. Medical management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: A consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care, 32(1):193-203 (2009).
  • 11. Garber AJ. AACE comprehensive diabetes management algorithm 2013. Endocr Pract, 19:327-336 (2013).
  • 12. Freemantle N et al. Availability of inhaled insulin promotes greater perceived acceptance of insulin therapy in patients with type 2 diabetes. Diabetes Care, 28(2):427-428 (2005).
  • 13. Rosenstock J, Cappelleri JC, Bolinder B, Gerber RA. Patient satisfaction and glycemic control after 1 year with inhaled insulin (Exubera) in patients with type 1 or type 2 diabetes. Diabetes Care, 27(6):1318-1323 (2004).
  • 14. Testa MA et al. Patient satisfaction with insulin therapy in type 2 diabetes randomized trial of injectable and inhaled insulin. Diabetes, 51(Suppl. 2):A135 (2002).
  • 15. Gerber RA, Cappelleri JC, Kourides IA, Gelfand RA. Treatment satisfaction with inhaled insulin in patients with type 1 diabetes: A randomized controlled trial. Diabetes Care, 24(9):1556-1559 (2001).
  • 16. Patton, Bukar JG, Eldon MA. Clinical pharmacokinetics and pharmacodynamics of inhaled insulin. Clin Pharmacokinet, 43(12):781-801 (2004).
  • 17. http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_01_01-Pfizer- Exubera.pdf.
  • 18. Quattrin T, Belanger A, Bohannon NJ, Schwartz SL; Exubera Phase III Study Group. 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(11):2622-2627 (2004).
  • 19. Skyler JS et al. Use of inhaled insulin in a basal/bolus insulin regimen in type 1 diabetic subjects: A 6-month, randomized, comparative trial. Diabetes Care, 28(7):1630-1635 (2005).
  • 20. Hollander PA et al. 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(10):2356-2362 (2004).
  • 21. Hollander PA et al. Body weight changes associated with insulin therapy. Diabetes Care, 30(10):2508-2510.
  • 22. Ceglia L, Lau J, Pittas AG. Meta-analysis: Efficacy and safety of inhaled insulin therapy in adults with diabetes mellitus. Ann Intern Med, 145(9):665-675 (2006).
  • 23. 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, 27(1):162-167 (2004).
  • 24. Gross JL et al. Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: A randomized noninferiority trial. Diabetes Technol Ther, 11(Suppl. 2):S27-S34 (2009).
  • 25. Burge M et al. Sustained long-term efficacy and safety of inhaled human insulin (Exubera®) following at least 8 years of continuous therapy, in 43rd EASD, Amsterdam, the Netherlands (2007).
  • 26. Liu MC et al. Effects of inhaled human insulin on airway lining fluid composition in adults with diabetes. EurRespir J, 32(1):180-188 (2008).
  • 27. Fan W et al. Inhaled aerosolized insulin ameliorates hyperglycemia-induced inflammatory responses in the lungs in experimental model of acute lung injury. Crit Care, 17:R83 (2013).
  • 28. Zhang WF, Zhu XX, Hu DH, Xu CF, Wang YC, Lv GF. Intensive insulin treatment attenuates burn-initiated lung injury in rats: Role of protective endothelium. J Burn Care Res, 32:51-58 (2011).
  • 29. Di Petta A et al. Insulin modulates inflammatory and repair responses to elastase- induced emphysema in diabetic rats. Int J Exp Path, 92:392-399 (2011).
  • 30. Guazzi M et al. Diabetes worsens pulmonary diffusion in heart failure, and insulin counteracts this effect. Am J Respir Crit Care Med, 166:978-982 (2002).
  • 31. Schernthaner G. Immunogenicity and allergenic potential of animal and human insulins. Diabetes Care, 16(Suppl. 3):155-165 (1993).
  • 32. Fineberg SE, Kawabata T, Finco-Kent D, Liu C, Krasner A. 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(6):3287-3294 (2005).
  • 33. Fineberg SE, Kawabata TT, Finco-Kent D, Fountaine RJ, Finch GL, Krasner AS. Immunological responses to exogenous insulin. Endocr Rev, 28(6):625-652 (2007).
  • 34. Teeter JG, Riese RJ. Dissociation of lung function changes with humoral immunity during inhaled human insulin therapy. Am J Respir Crit Care Med, 173(11):1194-1200 (2006).
  • 35. http://clinicaltrials.gov/ct2/results?term=FUSE+Study&Search=Search.
  • 36. Garg SK et al. Two-year efficacy and safety of AIR inhaled insulin in patients with type 1 diabetes: An open-label randomized controlled trial. Diabetes Technol Ther, 11(Suppl. 2):S5-S16 (2009).
  • 37. Balkau B, Kahn HS, Courbon D, Eschwege E, Ducimetiere P; Paris Prospective Study. Hyperinsulinemia predicts fatal liver cancer but is inversely associated with fatal cancer at some other sites: The Paris Prospective Study. Diabetes Care, 24(5):843-849 (2001).
  • 38. Jee SH, Ohrr H, Sull JW, Yun JE, Ji M, Samet JM. Fasting serum glucose level and cancer risk in Korean men and women. JAMA 293:194-202 (2005).
  • 39. Yang X et al. et al. Associations of hyperglycemia and insulin usage with the risk of cancer in type 2 diabetes: The Hong Kong diabetes registry. Diabetes 59:1254-1260.
 
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