Efficacy and Safety of Inhaled Insulin Therapy (2006)

Letters4 April 2006Efficacy and Safety of Inhaled Insulin TherapyJulio Rosenstock, MD, Bernard Zinman, MD, Liam J. Murphy, MD, Stephen C. Clement, MD, Paul Moore, MD, C. Keith Bowering, MD, Rosa Hendler, MD, Shu-Ping Lan, MPH, and William T. Cefalu, MDJulio Rosenstock, MDFrom Dallas Diabetes and Endocrine Center, Dallas, TX 75230; Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada; Georgetown University Hospital, Washington, DC 20007; Austin Diagnostic Clinic, Austin, TX 78758-2483; Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Yale University School of Medicine, New Haven, CT 06520-8020; Pfizer Inc., New London, CT 06320; and Louisiana State University, Baton Rouge, LA 70808.Search for more papers by this author, Bernard Zinman, MDFrom Dallas Diabetes and Endocrine Center, Dallas, TX 75230; Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada; Georgetown University Hospital, Washington, DC 20007; Austin Diagnostic Clinic, Austin, TX 78758-2483; Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Yale University School of Medicine, New Haven, CT 06520-8020; Pfizer Inc., New London, CT 06320; and Louisiana State University, Baton Rouge, LA 70808.Search for more papers by this author, Liam J. Murphy, MDFrom Dallas Diabetes and Endocrine Center, Dallas, TX 75230; Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada; Georgetown University Hospital, Washington, DC 20007; Austin Diagnostic Clinic, Austin, TX 78758-2483; Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Yale University School of Medicine, New Haven, CT 06520-8020; Pfizer Inc., New London, CT 06320; and Louisiana State University, Baton Rouge, LA 70808.Search for more papers by this author, Stephen C. Clement, MDFrom Dallas Diabetes and Endocrine Center, Dallas, TX 75230; Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada; Georgetown University Hospital, Washington, DC 20007; Austin Diagnostic Clinic, Austin, TX 78758-2483; Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Yale University School of Medicine, New Haven, CT 06520-8020; Pfizer Inc., New London, CT 06320; and Louisiana State University, Baton Rouge, LA 70808.Search for more papers by this author, Paul Moore, MDFrom Dallas Diabetes and Endocrine Center, Dallas, TX 75230; Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada; Georgetown University Hospital, Washington, DC 20007; Austin Diagnostic Clinic, Austin, TX 78758-2483; Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Yale University School of Medicine, New Haven, CT 06520-8020; Pfizer Inc., New London, CT 06320; and Louisiana State University, Baton Rouge, LA 70808.Search for more papers by this author, C. Keith Bowering, MDFrom Dallas Diabetes and Endocrine Center, Dallas, TX 75230; Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada; Georgetown University Hospital, Washington, DC 20007; Austin Diagnostic Clinic, Austin, TX 78758-2483; Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Yale University School of Medicine, New Haven, CT 06520-8020; Pfizer Inc., New London, CT 06320; and Louisiana State University, Baton Rouge, LA 70808.Search for more papers by this author, Rosa Hendler, MDFrom Dallas Diabetes and Endocrine Center, Dallas, TX 75230; Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada; Georgetown University Hospital, Washington, DC 20007; Austin Diagnostic Clinic, Austin, TX 78758-2483; Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Yale University School of Medicine, New Haven, CT 06520-8020; Pfizer Inc., New London, CT 06320; and Louisiana State University, Baton Rouge, LA 70808.Search for more papers by this author, Shu-Ping Lan, MPHFrom Dallas Diabetes and Endocrine Center, Dallas, TX 75230; Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada; Georgetown University Hospital, Washington, DC 20007; Austin Diagnostic Clinic, Austin, TX 78758-2483; Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Yale University School of Medicine, New Haven, CT 06520-8020; Pfizer Inc., New London, CT 06320; and Louisiana State University, Baton Rouge, LA 70808.Search for more papers by this author, and William T. Cefalu, MDFrom Dallas Diabetes and Endocrine Center, Dallas, TX 75230; Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada; Georgetown University Hospital, Washington, DC 20007; Austin Diagnostic Clinic, Austin, TX 78758-2483; Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Yale University School of Medicine, New Haven, CT 06520-8020; Pfizer Inc., New London, CT 06320; and Louisiana State University, Baton Rouge, LA 70808.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-144-7-200604040-00019 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:We agree that a limitation of our study was the open-label design. However, a double-blind study was not feasible because 1) it was not possible to manufacture a suitable placebo for inhaled human insulin, 2) it seemed inappropriate to blind treatment when individualized flexible-dose titration is needed, and 3) patients or physicians would have very easily unblinded the placebo or inhaled insulin because of the latter's immediate effect on blood glucose levels.Ours was a proof-of-concept study that was designed in 1998 according to good clinical practices at the time and was based on a previous study of ...References1. 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;163:2277-82. [PMID: 14581245] CrossrefMedlineGoogle Scholar2. Brown JB, Nichols GA, Perry A. The burden of treatment failure in type 2 diabetes. Diabetes Care. 2004;27:1535-40. [PMID: 15220224] CrossrefMedlineGoogle Scholar3. Comi RJ. Treatment of type 2 diabetes mellitus: a weighty enigma. [Editorial]. Ann Intern Med. 2005;143:609-10. [PMID: 16230728] LinkGoogle Scholar4. Freemantle N, Blonde L, Duhot D, Hompesch M, Eggertsen R, Hobbs FD, et al. Availability of inhaled insulin promotes greater perceived acceptance of insulin therapy in patients with type 2 diabetes. Diabetes Care. 2005;28:427-8. [PMID: 15677807] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Dallas Diabetes and Endocrine Center, Dallas, TX 75230; Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada; Georgetown University Hospital, Washington, DC 20007; Austin Diagnostic Clinic, Austin, TX 78758-2483; Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Yale University School of Medicine, New Haven, CT 06520-8020; Pfizer Inc., New London, CT 06320; and Louisiana State University, Baton Rouge, LA 70808.Disclosures: Employment: S.-P. Lan (Pfizer Inc.); Consultancies: J. Rosenstock (Pfizer Inc., sanofi-aventis, Novo Nordisk, GlaxoSmithKline, Takeda, Centocor, Johnson & Johnson, Amylin), B. Zinman (Eli Lilly Inc., sanofi-aventis, Pfizer Inc.), C.K. Bowering (Eli Lilly Inc., GlaxoSmithKline, Novo Nordisk, AstraZeneca); W.T. Cefalu (sanofi-aventis, Pfizer Inc.); Honoraria: J. Rosenstock (Pfizer Inc., sanofi-aventis, Novo Nordisk, GlaxoSmithKline, Takeda, Centocor, Johnson & Johnson, Amylin), B. Zinman (Eli Lilly Inc., sanofi-aventis, Pfizer Inc.), L.J. Murphy (Eli Lilly Inc., Pfizer Inc., GlaxoSmithKline, sanofi-aventis); C.K. Bowering (Eli Lilly Inc., GlaxoSmithKline, Novo Nordisk, AstraZeneca, Pfizer Inc., sanofi-aventis), W.T. Cefalu (sanofi-aventis, Pfizer Inc.); Stock ownership or options (other than mutual funds): S.-P. Lan (Pfizer Inc.); Grants received: J. Rosenstock (Merck, Pfizer Inc., sanofi-aventis, Novo Nordisk, Eli Lilly Inc., GlaxoSmithKline, Takeda, Novartis, AstraZeneca, Amylin, Sankyo, MannKind), B. Zinman (Pfizer Inc.), S.C. Clement (Pfizer Inc.), C.K. Bowering (GlaxoSmithKline, AstraZeneca, Pfizer Inc., sanofi-aventis), R. Hendler (Pfizer Inc.), W.T. Cefalu (Pfizer Inc.). PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoInhaled Insulin Improves Glycemic Control When Substituted for or Added to Oral Combination Therapy in Type 2 Diabetes Julio Rosenstock , Bernard Zinman , Liam J. Murphy , Stephen C. Clement , Paul Moore , C. Keith Bowering , Rosa Hendler , Shu-Ping Lan , and William T. Cefalu Treatment of Type 2 Diabetes Mellitus: A Weighty Enigma Richard J. 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