Safety and efficacy of inhaled human insulin (Exubera®) during discontinuation and readministration of therapy in adults with type 1 diabetes: A 3-year randomized controlled trial

Diabetes Research and Clinical Practice

Volumn 82, Issue 2, 2008, Pages 238-246

  Skyler, Jay S ^a   Hollander, Priscilla A ^b   Jovanovic, Lois ^c   Klioze, Sol ^d   Krasner, Alan ^d   Riese, Richard J ^d   Reis, Joann ^d   Schwartz, Pamela ^d   Duggan, William ^d  

^a UNIVERSITY OF MIAMI   (United States)

^b DALLAS DIABETES AND ENDOCRINE CENTER AT MEDICAL CITY   (United States)

^c SANSUM DIABETES RESEARCH INSTITUTE   (United States)

^d PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

A1C; DLCO; FEV1; Hypoglycemic events; Inhaled insulin; Insulin antibodies

Indexed keywords

CARBON MONOXIDE; GLUCOSE; INSULIN ANTIBODY; INSULIN ASPART; INSULIN GLARGINE; INSULIN LISPRO; INSULIN ZINC SUSPENSION; ISOPHANE INSULIN; RECOMBINANT HUMAN INSULIN;

ADULT; AGED; ANTIBODY RESPONSE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIABETIC PATIENT; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FORCED EXPIRATORY VOLUME; GLUCOSE BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; LUNG DIFFUSION CAPACITY; LUNG FUNCTION; LUNG FUNCTION TEST; MAJOR CLINICAL STUDY; RANDOMIZED CONTROLLED TRIAL; RECURRENCE RISK; SIDE EFFECT;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; AGED; DIABETES MELLITUS, TYPE 1; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 54549120176     PISSN: 01688227     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.diabres.2008.08.008     Document Type: Article

References (23)

1. Quattrin T., Belanger A., Bohannon N.J.V., and Schwartz S.L. 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 (2004) 2622-2627
2. Skyler J.S., Weinstock R.S., Raskin P., Yale J.-F., Barrett E., Gerich J.E., 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 (2005) 1630-1635
3. Norwood P., Dumas R., Cefalu W., Yale J.F., England R., Riese R.J., et al. 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. 92 (2007) 2211-2214
4. ®) in adult patients with type 1 diabetes mellitus. Diabetes Care 30 (2007) 579-585
5. Jensen R.L., Teeter J.G., England R.D., Howell H.M., White H.J., Pickering E.H., et al. Sources of long-term variability in measurements of lung function: Implications for interpretation and clinical trial design. Chest 132 (2007) 396-402
6. Jensen R.L., Teeter J.G., England R.D., Howell H.M., White H.J., Pickering E.H., et al. Instrument accuracy and reproducibility in measurements of pulmonary function. Chest 132 (2007) 388-395
7. Teeter J.G., and Reise R.J. Dissociation of lung function changes with humoral immunity during inhaled human insulin therapy. Am. J. Respir. Crit. Care Med. 119 (2006) 184-190
8. Hankinson J.L., Odencrantz J.R., and Fedan K.B. Spirometric reference values from a sample of the general U.S. population. Am. J. Respir. Crit. Care Med. 159 (1999) 179-187
9. Crapo R.O., Morris A.H., Clayton P.D., and Nixon C.R. Lung volumes in healthy nonsmoking adults. Bull. Eur. Physiopathol. Respir. 18 (1982) 419-425
10. Miller A., Thornton J.C., Warshaw R., Anderson H., Teirstein S.A., and Selikoff I.J. Single breath diffusing capacity in a representative sample of the population of Michigan, a large industrial state. Am. Rev. Respir. Dis. 127 (1983) 270-277
11. Viegi G., Sherrill D.L., Carrozzi L., Di Pede F., Baldacci S., Pistelli F., et al. An 8-year follow-up of carbon monoxide diffusing capacity in a general population sample of northern Italy. Chest 120 (2001) 74-80
12. Davis W.A., Knuiman M., Kendall P., Grande V., and Davis T.M.E. Glycemic exposure is associated with reduced pulmonary function in type 2 diabetes. The Fremantle Diabetes Study. Diabetes Care 27 (2004) 752-757
13. Weynand B., Jonckheere A., Frans A., and Rahier J. Diabetes mellitus induces a thickening of the pulmonary basal lamina. Respiration 66 (1999) 14-19
14. Farina J., Furio V., Fernandez-Acenero M.J., and Muzas M.A. Nodular fibrosis of the lung in diabetes mellitus. Virchows Arch. 427 (1995) 61-63
15. Hisa C.C., and Raskin P. Lung function changes related to diabetes mellitus. Diabetes Technol. Ther. 9 Suppl. 1 (2007) S73-S82
16. Fineberg S.E., Kawabata T., Finco-Kent D., Liu C., and 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 (2005) 3287-3294
17. Heise T., Bott S., Tusek C., Stephan J.-A., Kawabata T., Finco-Kent D., et al. The effect of insulin antibodies on the metabolic action of inhaled and subcutaneous insulin. A prospective randomized pharmacodynamic study. Diabetes Care 28 (2005) 2161-2169
18. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352 (1998) 837-853
19. Daousi C., Casson I.F., Gill G.V., MacFarlane I.A., Wilding J.P.H., and Pinkney J.H. Prevalence of obesity in type 2 diabetes in secondary care: association with cardiovascular risk factors. Postgrad. Med. J. 82 (2006) 280-284
20. International Obesity Task Force, 2003, Diabetes Atlas second edition, Available from http://www.eatlas.idf.org/Obesity_and_type_2_diabetes. Last accessed 14th June, 2007.
21. Henry R.R., Gumbiner B., Ditzler T., Wallace P., Lyon R., and Glauber H.S. Intensive conventional insulin therapy for type II diabetes. Diabetes Care 16 (1993) 21-31
22. Farmer A., Kinmonth A.-L., and Sutton S. Measuring beliefs about taking hypoglycaemic medication among people with type 2 diabetes. Diabetic Med. 23 (2006) 265-270
23. ®) versus subcutaneous insulin in five controlled phase 3 trials. Diabetes Care 30 (2007) 2508-2510