Pulmonary function over 2 years in diabetic patients treated with prandial inhaled Technosphere Insulin or usual antidiabetes treatment: A randomized trial

Diabetes, Obesity and Metabolism

Volumn 14, Issue 2, 2012, Pages 163-173

  Raskin, P ^a   Heller, S ^b   Honka, M ^c,e   Chang, P C ^d   Boss, A H ^d   Richardson, P C ^d   Amin, N ^d  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^c UNIVERSITY HOSPITAL OSTRAVA   (Czech Republic)

^d MannKind Corporation   (United States)

^e CHARLES UNIVERSITY   (Czech Republic)

Author keywords

Diabetes; Inhaled insulin; Pulmonary function; Technosphere Insulin; Usual antidiabetes treatment

Indexed keywords

CARBON MONOXIDE; HEMOGLOBIN A1C; INSULIN;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; COUGHING; DIABETIC PATIENT; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INFLUENZA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; INTENTION TO TREAT ANALYSIS; LUNG DIFFUSION CAPACITY; LUNG FUNCTION; LUNG FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; TOTAL LUNG CAPACITY; TREATMENT WITHDRAWAL; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION;

EID: 84855359884     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/j.1463-1326.2011.01500.x     Document Type: Article

References (35)

1. Litonjua AA, Lazarus R, Sparrow D, Demolles D, Weiss ST. Lung function in type 2 diabetes: the Normative Aging Study. Respir Med 2005; 99: 1583-1590.
2. Davis WA, Knuiman M, Kendall P, Grange V, Davis TM. Glycemic exposure is associated with reduced pulmonary function in type 2 diabetes: the Fremantle Diabetes Study. Diabetes Care 2004; 27: 752-757.
3. Hsia CC, Raskin P. Lung function changes related to diabetes mellitus. Diabetes Technol Ther 2007; 9(Suppl. 1): S73-82.
4. Klein OL, Krishnan JA, Glick S, Smith LJ. Systematic review of the association between lung function and Type 2 diabetes mellitus. Diabet Med 2010; 27: 977-987.
5. van den Borst B, Gosker HR, Zeegers MP, Schols AM. Pulmonary function in diabetes: a metaanalysis. Chest 2010; 138: 393-406.
6. Yeh HC, Punjabi NM, Wang NY et al. Cross-sectional and prospective study of lung function in adults with type 2 diabetes: the Atherosclerosis Risk in Communities (ARIC) study. Diabetes Care 2008; 31: 741-746.
7. 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.
8. Garg SK, Mathieu C, Rais N 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 2009; 11(Suppl. 2): S5-16.
9. Rosenstock J, Cefalu WT, Hollander PA et al. Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes. Diabetes Care 2008; 31: 1723-1728.
10. 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.
11. Rosenstock J, Cefalu WT, Hollander PA, Klioze SS, Reis J, Duggan WT. Safety and efficacy of inhaled human insulin (Exubera) during discontinuation and readministration of therapy in adults with type 2 diabetes: a 3-year randomized controlled trial. Diabetes Technol Ther 2009; 11: 697-705.
12. Skyler JS, Hollander PA, Jovanovic L et al. 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 Res Clin Pract 2008; 82: 238-246.
13. ®/Insulmimicking endogenous insulin release. Rathbone M, Hadgraft J, Roberts M, Lane M eds. Modified Release Drug Delivery Technology, 2nd edn, Vol 2. New York: Informa Healthcare USA, Inc.; 2008: 673-679.
14. ® Insulin technology. Diabetes Technol Ther 2007; 9(Suppl. 1): S65-72.
15. ® Insulin inhalation powder administration. Pharm Res 2011; 28: 2157-2164.
16. Potocka E, Cassidy JP, Haworth P, Heuman D, van Marle S, Baughman RA. Pharmacokinetic characterization of the novel pulmonary delivery excipient fumaryl diketopiperazine. J Diabetes Sci Technol 2010: 4: 1164-1173.
17. Rosenstock J, Lorber DL, Gnudi L et al. Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomised trial. Lancet 2010; 375: 2244-2253.
18. ® Insulin demonstrates reduction in postprandial glucose excursions and hemoglobin A1c in patients with type 2 diabetes. J Diabetes Sci Technol 2008; 2: 47-57.
19. Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med 1999; 159: 179-187.
20. Miller A, Thornton JC, Warshaw R, Anderson H, Teirstein AS, Selikoff IJ. Single breath diffusing capacity in a representative sample of the population of Michigan, a large industrial state. Predicted values, lower limits of normal, and frequencies of abnormality by smoking history. Am Rev Respir Dis 1983; 127: 270-277.
21. Morris AH, Kanner RE, Crapo RO, Gardner RM. Clinical pulmonary function testing: a manual of uniform laboratory procedures, 2nd edn. Salt Lake City, UT: Intermountain Thoracic Society; 1984.
22. American Diabetes Association. Standards of medical care in diabetes-2007. Diabetes Care 2007; 30(Suppl. 1): S4-41.
23. Rodbard HW, Blonde L, Braithwaite SS et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract 2007; 13(Suppl. 1): 1-68.
24. Miller MR, Hankinson J, Brusasco V et al. Standardisation of spirometry. Eur Respir J 2005; 26: 319-338.
25. Wanger J, Clausen JL, Coates A et al. Standardisation of the measurement of lung volumes. Eur Respir J 2005; 26: 511-522.
26. MacIntyre N, Crapo RO, Viegi G et al. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J 2005; 26: 720-735.
27. Petrucci R, Amin N, Lovertin P, Boss A, Richardson P. Pulmonary function tests remain similar in patients who received Technosphere insulin and in patients currently receiving standard antidiabetic therapy (Abstract 919). Diabetologia 2009; 52(Suppl. 1): S361.
28. James AL, Palmer LJ, Kicic E et al. Decline in lung function in the Busselton Health Study: the effects of asthma and cigarette smoking. Am J Respir Crit Care Med 2005; 171: 109-114.
29. Duncan BB, Schmidt MI, Pankow JS et al. Low-grade systemic inflammation and the development of type 2 diabetes: the atherosclerosis risk in communities study. Diabetes 2003; 52: 1799-1805.
30. Jensen RL, Teeter JG, England RD et al. Sources of long-term variability in measurements of lung function: implications for interpretation and clinical trial design. Chest 2007; 132: 396-402.
31. Wise RA, Teeter JG, Jensen RL et al. Standardization of the single-breath diffusing capacity in a multicenter clinical trial. Chest 2007; 132: 1191-1197.
32. Blonshine S, Harris R, Snow M. Evaluation of biologic quality control variance in a multi-center clinical trial for inhaled insulin (e-poster 229). Presented at Annual Congress of the European Respiratory Society; September 15-19, 2007; Stockholm, Sweden.
33. Wanger J, Irvin C. Comparability of pulmonary function results from 13 laboratories in a metropolitan area. Respir Care 1991; 36: 1375-1382.
34. Greene S, Nikula K, Reynolds J et al. Long-term pulmonary safety assessment of Afrezza™ in rats and dogs (Abstract PS 811). The Toxicologist 2011; 120(Suppl. 2): 175.
35. Liu MC, Riese RJ, Van Gundy K et al. Effects of inhaled human insulin on airway lining fluid composition in adults with diabetes. Eur Respir J 2008; 32: 180-188.