Role of inhaled human insulin in the management of Type 1 and 2 diabetes

References

• American Diabetes Association Clinical Practice Recommendations. Diagnosis and classification of diabetes mellitus. Diabetes Care27(1), S5–S11 (2004).
   PubMedGoogle Scholar
• Pinhas-Hamiel O, Dolan LM, Daniels SR, Standford D, Khoury PR, Zeitler P. Increased incidence of non-insulin-dependent diabetes mellitus among adolescents. J. Pediatr.128, 608–615 (1996).
   PubMed Web of Science ®Google Scholar
• The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N. Engl. J. Med.329(14), 977–986 (1993).
   PubMed Web of Science ®Google Scholar
• UKPDS Group. Intensive blood-glucose control with sulfonylureas or insulin compared with conventional treatment and risk of complication in patients with Type 2 diabetes (UKPDS33). Lancet352, 827–853 (1998).
   Google Scholar
• Koro CE, Bowlin SJ, Bourgeois N, Fedder DO. Glycemic control from 1988 to 2000 among U.S. adults diagnosed with Type 2 diabetes. Diabetes Care27(1), 17–20 (2004).
   PubMed Web of Science ®Google Scholar
• Riddle MC, Rosenstock J, Gerich J. The treat-to-target trial: Randomized addition of glargine or human NPH insulin to oral therapy of Type 2 diabetic patients. Diabetes Care26(11), 3080–3086 (2003).
   PubMed Web of Science ®Google Scholar
• Wright A, Burden ACF, Paisey RB, Cull CA, Holman RR. UK diabetes Study Group. Sulfonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with Type 2 diabetes in the UK prospective diabetes study (UKPDS 57). Diabetes Care25, 330–336 (2002).
   PubMed Web of Science ®Google Scholar
• Cefalu WT. Novel routes of insulin delivery for patients with Type 1 or Type 2 diabetes. Ann. Med.33(9), 579–586 (2001).
   PubMed Web of Science ®Google Scholar
• Patton JS. Unlocking the opportunity of tight glycemic control: innovative delivery of insulin via the lung. Diab. Obes. Metab.7(Suppl. 1), S5–S8 (2005).
   PubMedGoogle Scholar
• Ghilzai N. An overview of pulmonary drug delivery. Drug Delivery Companies Report, Spring/Summer, 18–22 (2005).
   Google Scholar
• Patton JS. Mechanisms of macromolecule absorption by the lungs. Adv. Drug Del. Rev.19(1), 3–36 (1996).
   Web of Science ®Google Scholar
• Patton JS, Bukar J, Nagarajan S. Inhaled insulin. Adv. Drug Del. Rev.35(2–3), 235–247 (1999).
   PubMed Web of Science ®Google Scholar
• Mandal TK. Inhaled insulin for diabetes mellitus. Am. J. Health Sys. Pharm.62(16), 1659–1664 (2005).
   Google Scholar
• Barnett AH. Exubera inhaled insulin: a review. Int. J. Clin. Prac.58(4), 394–401 (2004).
   PubMed Web of Science ®Google Scholar
• Heinemann L, Heise T. Current status of the development of inhaled insulin. Br. J. Diab. Vasc. Dis.4(5), 295–301 (2004).
   Google Scholar
• Cefalu WT. Concept, strategies, and feasibility of noninvasive insulin delivery. Diabetes Care27, 239–246 (2004).
   PubMed Web of Science ®Google Scholar
• Wigley FM, Londono JH, Wood SH, Shipp JC, Waldman RH. Insulin across respiratory mucosae by aerosol delivery. Diabetes20, 552–556 (1971).
   PubMed Web of Science ®Google Scholar
• Owens DR, Zinman B, Bolli G. Alternative routes of insulin delivery. Diab. Med.20(11), 886–898 (2003).
   PubMed Web of Science ®Google Scholar
• Cherrington AD, Neal DW, Edgerton DS et al. Inhalation of insulin in dogs: assessment of insulin levels and comparison to subcutaneous injection. Diabetes53, 877–881 (2004).
   PubMed Web of Science ®Google Scholar
• Edgerton DS, Cherrington AD, Neal DW et al. Inhalation of insulin (Exubera) compared to matched intravenous infusion: hepatic glucose balance post intraportal glucose infusion in dogs. Diabetes53(Suppl. 2), A108–A109 (2004).
   Google Scholar
• Heinemann L, Traut T, Heise T. Time–action profile of inhaled insulin. Diab. Med.14(1), 63–72 (1997).
   PubMed Web of Science ®Google Scholar
• Heise T, Rave K, Bott S, Sha S, Willavize S, Carrol R et al. Time-action profile of an inhaled insulin preparation in comparison to insulin lispro and regular insulin (abstract 39-OR). Diabetes49(Suppl. 1), A10 (2000).
   Google Scholar
• Rave K, Bott S, Heinemann L et al. Time–action profile of inhaled insulin in comparison with subcutaneously injected insulin lispro and regular human insulin. Diabetes Care,28(5), 1077–1082 (2005).
   PubMed Web of Science ®Google Scholar
• Rave KM, Nosek L, De La Pena A et al. Dose response of inhaled dry-powder insulin and dose equivalence to subcutaneous insulin lispro. Diabetes Care28(10), 2400–2405 (2005).
   PubMed Web of Science ®Google Scholar
• Skyler JS, Cefalu WT, Kourides IA et al. Efficacy of inhaled human insulin in Type 1 diabetes mellitus: A randomized proof-of-concept study. Lancet357(9253), 331–335 (2001).
   PubMed Web of Science ®Google Scholar
• Quattrin T, Belanger A, Bohannon NJV, Schwartz SL (The Exubera Phase III Study Group). Efficacy and safety of inhaled insulin (Exubera) compared to subcutaneous insulin therapy in patients with Type 1 diabetes: results of a 6-month, randomized, comparative trail. Diabetes Care,27, 2622–2627 (2004).
   PubMed Web of Science ®Google Scholar
• Skyler JS, Weinstock RS, Raskin P et al. Use of inhaled insulin in a basal/bolus insulin regimen in Type 1 diabetic subjects: a 6-month, randomized, comparative trial. Diabetes Care28, 1630–1635 (2005).
   PubMed Web of Science ®Google Scholar
• Weiss SR, Cheng S, Kourides IA, Gelfand RA, Landschulz WH (The Inhaled Insulin Phase II Study Group). Inhaled insulin provides improved glycemic control in patients with Type 2 diabetes mellitus inadequately controlled with oral agents: a randomized controlled trial. Arch. Int. Med.163(19), 2277–2282 (2003).
   PubMed Web of Science ®Google Scholar
• Hollander PA, Blonde L, Rowe R, Mehta AE, Milburn JL, Hershon KS (The Exubera Phase III Study Group). 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 (2004).
   PubMed Web of Science ®Google Scholar
• Henry RR, Mudaliar S, Chu N et al. Young and elderly Type 2 diabetic patient inhaling insulin with the AERx insulin diabetes management system: a pharmacokinetic and pharmacodynamic comparison. J. Clin. Pharmacol.43, 1228–1234 (2003).
   PubMed Web of Science ®Google Scholar
• Defronzo RA, Bergenstal RM, Cefalu WT et al. (The 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 Care28(8), 1922–1192 (2005).
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Zinman B, Murphy L et al. Inhaled insulin improves glycemic control when substituted for or added to oral combination therapy in Type 2 diabetes. Ann. Int. Med.143(8), 549–558 (2005).
   PubMed Web of Science ®Google Scholar
• Edgerton D, Neal D, Scott M et al. Inhalation of insulin (Exubera) is associated with augmented disposal of portally infused glucose in dogs. Diabetes54, 1164–1170 (2005).
   PubMed Web of Science ®Google Scholar
• Odegard PS, Capoccia KL. Inhaled insulin: Exubera. Ann. Pharm.39(5), 843–853 (2005).
   PubMed Web of Science ®Google Scholar
• Perera AD, Kapitza C, Nosek L et al. Absorption and metabolic effect of inhaled insulin: intrapatient variability after inhalation via the aerodose insulin inhaler in patients with Type 2 diabetes. Diabetes Care25, 2276–2281 (2002).
   PubMed Web of Science ®Google Scholar
• 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, 162–167 (2004).
   PubMed Web of Science ®Google Scholar
• Stoever JA, Palmer JP. Inhaled insulin and insulin antibodies: a new twist to an old debate. Diab. Tech. Ther.4(2), 157–161 (2002).
   PubMedGoogle Scholar
• Heise T, Bott S, Tusek C et al. The effect of insulin antibodies on the metabolic action of inhaled and subcutaneous insulin: a prospective randomized pharmacodynamic study. Diabetes Care28(9), 2161–2169 (2004).
   Google Scholar
• 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).
   PubMed Web of Science ®Google Scholar
• Skyler JS, Gelfand RA, Kourides IA. Treatment of Type 1 diabetes mellitus with inhaled human insulin: a 3-month, multi-center trial. Diabetes51(Suppl. 2), A61 (2002).
   Google Scholar
• Rosentstock J, Cappelleri J, Bolinder B, Gerber R. Patient satisfaction and glycemic control after 1 year with inhaled insulin (Exubera) in patients with Type 1 or Type 2 diabetes. Diabetes Care27, 1618–1623 (2004).
   PubMedGoogle Scholar
• Barnett AH (The Exubera Phase III Study Group). 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. Diabetes53, A107 (2004).
   Google Scholar
• Henry R, Mudaliar S, Howland W et al. Inhaled insulin using the AERx insulin diabetes management system in healthy and asthmatic subjects. Diabetes Care26(3), 764–769 (2003).
   PubMed Web of Science ®Google Scholar
• Sha S, Becker R HA, Willavise SA et al. The effect of smoking cessation on the absorption of inhaled insulin (Exubera). Diabetes51(Suppl. 1), A163 (2002).
   Google Scholar
• Testa M, Turner R, Hayes J, Simonson D. Patient satisfaction and quality of life in Type 1 diabetes: a randomized trial of injectable vs. inhaled insulin (Abstract). Diabetes50(Suppl. 2), A45 (2001).
   Web of Science ®Google Scholar
• Testa M, Turner R, Hayes J, Simonson D. Patient satisfaction and quality of life in Type 2 diabetes: a randomized trial of injectable vs. inhaled insulin (Abstract). Diabetes51(Suppl. 2), A165 (2002).
   Google Scholar
• Gerber RA, Cappelleri JC, Bell-Farrow AD, English JS, Agramonte RF, Gelfand RA. Improved patient satisfaction with inhaled insulin in subjects with Type 1 diabetes mellitus after one year: results from a multicenter extension trial. Diabetes49(Suppl. 1), A108 (2000).
   PubMedGoogle Scholar
• 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.24(4), 552–564 (2002).
   PubMed Web of Science ®Google Scholar
• Skyler JS, Gelfand RA, Kourides IA. Treatment of Type 1 diabetes mellitus with inhaled human insulin: a 3-month, multi-center trial. Diabetes51(Suppl. 2), A61 (2002).
   Google Scholar
• Cefalu WT, Skyler JS, Kourides IA et al. Inhaled human insulin treatment in patients with Type 2 diabetes mellitus. Ann. Int. Med.164(3), 203–207 (2001).
   Google Scholar
• Feemantle N, Blonde L, Duhot D et al. Availability of inhaled insulin promotes greater perceived acceptance of insulin therapy in patients with Type 2 diabetes. Diabetes Care28, 427–428 (2005).
   PubMedGoogle Scholar