Treatment safety and efficacy of inhaled insulin (AERx® iDMS 1) compared with subcutaneous insulin therapy in patients with type 1 diabetes: 1-year data from a randomized, parellel group trial

Diabetic Medicine

Volumn 26, Issue 3, 2009, Pages 260-267

  Moses, R G ^a,i   Bartley, P ^b   Lunt, H ^c   O'Brien, R C ^d   Donnelly, T ^e   Gall, M A ^f   Vesterager, A ^f   Wollmer, P ^g   Roberts, A ^h  

^a Stoneham Chambers ^*  (Australia)

^b Stoneham Chambers   (Australia)

^c CHRISTCHURCH HOSPITAL   (New Zealand)

^d UNIVERSITY OF MELBOURNE   (Australia)

^e Diabetes Management Centre   (Australia)

^f NOVO NORDISK A S   (Denmark)

^g LUND UNIVERSITY HOSPITAL   (Sweden)

^h South Australian Endocrine Clinical Research   (Australia)

ⁱ UNIVERSITY OF WOLLONGONG   (Australia)

Author keywords

Aspart insulin; Basal bolus; Inhaled insulin; Type 1 diabetes

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN; ISOPHANE INSULIN; ANTIDIABETIC AGENT;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIABETIC KETOACIDOSIS; DRUG DELIVERY SYSTEM; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; FEMALE; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HYPOGLYCEMIA; HYPOGLYCEMIC COMA; INSULIN DEPENDENT DIABETES MELLITUS; LUNG FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RISK ASSESSMENT; THORAX RADIOGRAPHY; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; DRUG ADMINISTRATION; INHALATIONAL DRUG ADMINISTRATION; METHODOLOGY; MIDDLE AGED; SUBCUTANEOUS DRUG ADMINISTRATION;

ADMINISTRATION, INHALATION; ADULT; DIABETES MELLITUS, TYPE 1; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; INJECTIONS, SUBCUTANEOUS; INSULIN; MALE; MIDDLE AGED; RISK ASSESSMENT;

EID: 62449219273     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/j.1464-5491.2008.02654.x     Document Type: Article

References (27)

1. Reichard P, Nilsson BY, Rosenqvist U. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N Engl J Med 1993 329 : 304 309.
2. 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. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993 329 : 977 986.
3. Mollema ED, Snoek FJ, Heine RJ, van der Ploeg HM. Phobia of self-injecting and self-testing in insulin-treated diabetes patients: opportunities for screening. Diabet Med 2001 18 : 671 674.
4. Zambanini A, Newson RB, Maisey M, Feher MD. Injection related anxiety in insulin-treated diabetes. Diabetes Res Clin Pract 1999 46 : 239 246.
5. Skyler JS, Weinstock RS, Raskin P, Yale JF, Barrett E, Gerich JE 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 2005 28 : 1630 1635.
6. 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.
7. Rave K, Bott S, Heinemann L, Sha S, Becker RH, Willavize SA et al. Time-action profile of inhaled insulin in comparison with subcutaneously injected insulin lispro and regular human insulin. Diabetes Care 2005 28 : 1077 1082.
8. Wollmer P, Pieber TR, Gall MA, Brunton S. Delivering needle-free insulin using AERx iDMS (insulin diabetes management system) technology. Diabetes Technol Ther 2007 9 : S57 S64.
9. Thipphawong J, Otulana B, Clauson P, Okikawa J, Farr SJ. Pulmonary insulin administration using the AERx insulin diabetes system. Diabetes Technol Ther 2002 4 : 499 504.
10. Farr SJ, McElduff A, Mather LE, Okikawa J, Ward ME, Gonda I et al. Pulmonary insulin administration using the AERx system: physiological and physicochemical factors influencing insulin effectiveness in healthy fasting subjects. Diabetes Technol Ther 2000 2 : 185 197.
11. Cramer JA, Okikawa J, Bellaire S, Clauson P. Compliance with inhaled insulin treatment using the AERx iDMS Insulin Diabetes Management System. Diabetes Technol Ther 2004 6 : 800 807.
12. Brunner GA, Balent B, Ellmerer M, Schaupp L, Siebenhofer A, Jendle JH et al. Dose-response relation of liquid aerosol inhaled insulin in Type I diabetic patients. Diabetologia 2001 44 : 305 308.
13. Kapitza C, Hompesch M, Scharling B, Heise T. Intrasubject variability of inhaled insulin in Type 1 diabetes: a comparison with subcutaneous insulin. Diabetes Technol Ther 2004 6 : 466 472.
14. ® iDMS compared to subcutaneous human insulin and subcutaneous insulin aspart. Diabetologia 2005 48 : A31.
15. 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.
16. 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.
17. Skyler JS, Jovanovic L, Klioze S, Reis J, Duggan W. Two-year safety and efficacy of inhaled human insulin (Exubera) in adult patients with Type 1 diabetes. Diabetes Care 2007 30 : 579 585.
18. Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl 1993 16 : 5 40.
19. Lindholm A, Jensen LB, Home PD, Raskin P, Boehm BO, Rastam J. Immune responses to insulin aspart and biphasic insulin aspart in people with Type 1 and Type 2 diabetes. Diabetes Care 2002 25 : 876 882.
20. Fomsgaard A, Dinesen B. ELISA for human IgG and IgM anti- lipopolysaccharide antibodies with indirect standardization. J. Immunoassay 1989 8, 333 350.
21. Garg S, Rosenstock J, Silverman BL, Sun B, Konkoy CS, de la PA et al. Efficacy and safety of preprandial human insulin inhalation powder versus injectable insulin in patients with Type 1 diabetes. Diabetologia 2006 49 : 891 899.
22. Horvath K, Jeitler K, Berghold A, Ebrahim SH, Gratzer TW, Plank J et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for Type 2 diabetes mellitus. Cochrane Database Syst Rev 2007 CD005613.
23. Barnett AH, Lange P, Dreyer M, Serdarevic-Pehar M. Long-term tolerability of inhaled human insulin (Exubera) in patients with poorly controlled Type 2 diabetes. Int J Clin Pract 2007 61 : 1614 1625.
24. Brannan JD, Anderson SD, Perry CP, Freed-Martens R, Lassig AR, Charlton B. The safety and efficacy of inhaled dry powder mannitol as a bronchial provocation test for airway hyperresponsiveness: a phase 3 comparison study with hypertonic (4.5%) saline. Respir Res 2005 6 : 144.
25. 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 2005 90 : 3287 3294.
26. ® insulin Diabetes Management System (iDMS) in subjects with Type 1 diabetes, naïve and non-naïve to inhaled insulin. Diabet Med 2006 23 : 788.
27. Edgerton DS, Cherrington AD, Williams P, Neal DW, Scott M, Bowen L et al. Inhalation of human insulin (Exubera) augments the efficiency of muscle glucose uptake in vivo. Diabetes 2006 55 : 3604 3610.