Efficacy of inhaled human insulin in type 1 diabetes mellitus: a randomised proof-of-concept study

Skyler, Jay S.; Cefalu, William T.; Kourides, Ione A.; Landschulz, William; Balagtas, Cecile C.; Cheng, Shu Lin; Gelfand, R

doi:10.1016/s0140-6736(00)03638-2

Cited by 279 publications

(168 citation statements)

References 21 publications

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“…Published reports already exist demonstrating the feasibility of inhaled insulin administered via less sophisticated inhalation devices than AERx 1 iDMS. For example, a small-scale, open-label, randomized trial demonstrated that, compared with subcutaneous insulin therapy, 41 ease of administration was significantly improved when using inhaled insulin. 40 There was also no significant difference in the metabolic control of patients on inhaled insulin compared with injected insulin.…”

Section: S22mentioning

confidence: 99%

When oral agents fail: practical barriers to starting insulin

2002

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Insulin therapy has proven benefits in Type 2 diabetes patients when combination therapy has failed. However, there is some reluctance by both patients and healthcare professionals to initiate insulin therapy. This reluctance has been termed 'psychological insulin resistance'. Barriers to the initiation of insulin therapy include patients' fear of disease progression and needle anxiety; mutual concerns about hypoglycaemia and weight gain; and health professionals' use of insulin as a threat to encourage compliance with earlier therapies. It is essential that these obstacles are identified and investigated as a means of overcoming these impediments to recommended levels of glycaemic control, an initiative being pursued by the DAWN study. Where concerns are tangible, such as fear of hypoglycaemia, therapeutic solutions can be pursued. Overcoming psychological barriers relies more on innovative management techniques. Improving insulin delivery to meet these needs, coupled with enhanced healthcare services, can address psychological insulin resistance and contribute to the maintenance of good metabolic control.

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Section: S22mentioning

confidence: 99%

When oral agents fail: practical barriers to starting insulin

2002

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“…Inhaled insulin may provide an alternative for the management of type 1 diabetes as part of a basal/bolus strategy in patients who are unwilling or unable to use preprandial insulin injections. Results of a proof-of-concept study have suggested that inhaled insulin could replace preprandial subcutaneous insulin injections in type 1 diabetic subjects (10,11). A larger study demonstrating that inhaled insulin can provide glycemic control comparable with that of conventional subcutaneous insulin has reinforced this idea (12).…”

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confidence: 99%

Use of Inhaled Insulin in a Basal/Bolus Insulin Regimen in Type 1 Diabetic Subjects

et al. 2005

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OBJECTIVE -Despite the demonstrated benefits of glycemic control, patient acceptance of basal/bolus insulin therapy for type 1 diabetes has been slow. We investigated whether a basal/ bolus insulin regimen involving rapid-acting, dry powder, inhaled insulin could provide glycemic control comparable with a basal/bolus subcutaneous regimen.RESEARCH DESIGN AND METHODS -Patients with type 1 diabetes (ages 12-65 years) received twice-daily subcutaneous NPH insulin and were randomized to premeal inhaled insulin (n ϭ 163) or subcutaneous regular insulin (n ϭ 165) for 6 months.RESULTS -Mean glycosylated hemoglobin (A1C) decreased comparably from baseline in the inhaled and subcutaneous insulin groups (Ϫ0.3 and Ϫ0.1%, respectively; adjusted difference Ϫ0.16% [CI Ϫ0.34 to 0.01]), with a similar percentage of subjects achieving A1C Ͻ7%. Although 2-h postprandial glucose reductions were comparable between the groups, fasting plasma glucose levels declined more in the inhaled than in the subcutaneous insulin group (adjusted difference Ϫ39.5 mg/dl [CI Ϫ57.5 to Ϫ21.6]). Inhaled insulin was associated with a lower overall hypoglycemia rate but higher severe hypoglycemia rate. The overall hypoglycemia rate (episodes/patient-month) was 9.3 (inhaled) vs. 9.9 (subcutaneous) (risk ratio [RR] 0.94 [CI 0.91-0.97]), and the severe hypoglycemia rate (episodes/100 patient-months) was 6.5 vs. 3.3 (RR 2.00 ). Increased insulin antibody serum binding without associated clinical manifestations occurred in the inhaled insulin group. Pulmonary function between the groups was comparable, except for a decline in carbon monoxideϪdiffusing capacity in the inhaled insulin group without any clinical correlates.CONCLUSIONS -Inhaled insulin may provide an alternative for the management of type 1 diabetes as part of a basal/bolus strategy in patients who are unwilling or unable to use preprandial insulin injections.

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“…Recently, a series of multicenter trials of inhaled human insulin (Exubera [insulin human (rDNA origin)] Inhalation Powder; Pfizer, Inc., New York, NY; and Nektar Therapeutics, San Carlos, CA) was completed in individuals with type 1 and 2 diabetes (13)(14)(15)(16)(17)(18)(19)(20)(21)(22). Serial DL CO measurements were obtained in participants receiving inhaled insulin and in comparator participants receiving no inhaled therapy.…”

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confidence: 99%

Intersession Variability in Single-Breath Diffusing Capacity in Diabetics without Overt Lung Disease

Drummond¹,

Schwartz²,

Duggan³

et al. 2008

Am J Respir Crit Care Med

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Rationale: American Thoracic Society guidelines state that a 10% or greater intersession change in diffusing capacity of the lung (DL CO ) should be considered clinically significant. However, little is known about the short-term intersession variability in DL CO in untrained subjects or how variability is affected by rigorous external quality control. Objectives: To characterize the intersession variability of DL CO and the effect of different quality control methods in untrained individuals without significant lung disease. Methods: Data were pooled from the comparator arms of 14 preregistration trials of inhaled insulin that included nonsmoking diabetic patients without significant lung disease. A total of 699 participants performed repeated DL CO measurements using a highly standardized technique. A total of 948 participants performed repeated measurements using routine clinical testing. Measurements and Main Results:The mean intersession absolute change in DL CO using the highly standardized method was 1.45 ml/ minute/mm Hg (5.64%) compared with 2.49 ml/minute/mm Hg (9.52%) in the routine testing group (P , 0.0001 for both absolute and percent difference). The variability in absolute intersession change in DL CO increased with increasing baseline DL CO values, whereas the absolute percentage of intersession change was stable across baseline values. Depending on the method, 15.5 to 35.5% of participants had an intersession change of 10% or greater. A 20% or greater threshold would reduce this percentage of patients to 1 to 10%. Conclusions: Intersession variability in DL CO measurement is dependent on the method of testing used and baseline DL CO . Using a more liberal threshold to define meaningful intersession change may reduce the misclassification of normal variation as abnormal change.

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Efficacy of inhaled human insulin in type 1 diabetes mellitus: a randomised proof-of-concept study

Cited by 279 publications

References 21 publications

When oral agents fail: practical barriers to starting insulin

When oral agents fail: practical barriers to starting insulin

Use of Inhaled Insulin in a Basal/Bolus Insulin Regimen in Type 1 Diabetic Subjects

Intersession Variability in Single-Breath Diffusing Capacity in Diabetics without Overt Lung Disease

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