Exubera (Insulin Human Inhalation) - Summary

EXUBERA SUMMARY

EXUBERA^® consists of blisters containing human insulin inhalation powder, which are administered using the EXUBERA^® Inhaler. EXUBERA blisters contain human insulin produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12).

EXUBERA is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. EXUBERA has an onset of action similar to rapid-acting insulin analogs and has a duration of glucose-lowering activity comparable to subcutaneously administered regular human insulin. In patients with type 1 diabetes, EXUBERA should be used in regimens that include a longer-acting insulin. In patients with type 2 diabetes, EXUBERA can be used as monotherapy or in combination with oral agents or longer-acting insulins.

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NEWS HIGHLIGHTS

Published Studies Related to Exubera (Insulin Inhalation)

Population pharmacokinetic model of human insulin following different routes of administration. [2011.07]
Multiple-compartment disposition of insulin has been demonstrated following intravenous administration; however, because of slow absorption and flip-flop kinetics, meal-time insulin pharmacokinetics have been described by a 1-compartment model. Technosphere insulin (TI) is an inhaled human insulin with rapid absorption and a distinct second compartment in its pharmacokinetics...

Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomised trial. [2010.06.26]
BACKGROUND: Insulin therapy is often a delayed strategy in patients with type 2 diabetes mellitus because it is associated with weight gain, hypoglycaemia, and the need for subcutaneous injections. We aimed to assess the efficacy and safety of prandial Technosphere inhaled insulin compared with twice daily biaspart insulin... INTERPRETATION: This study is part of a large clinical development programme addressing the efficacy and tolerability of use of Technosphere inhaled insulin in a wide variety of patients. FUNDING: MannKind. Copyright 2010 Elsevier Ltd. All rights reserved.

The contribution of pretreatment expectations and expectation-perception difference to change in treatment satisfaction and end point treatment satisfaction in the context of initiation of inhaled insulin therapy in patients with type 2 diabetes. [2010.06]
BACKGROUND: This study explored relationships among pretreatment expectations, treatment perceptions, expectation-perception difference, change in diabetes treatment satisfaction, and end point diabetes treatment satisfaction in individuals with type 2 diabetes... CONCLUSIONS: Pretreatment expectations and expectation-perception difference play an important role in the amount of change that occurs in satisfaction with new treatment as compared to that of previous treatment, as well as satisfaction with new treatment.

Expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction in insulin-naive patients with type 2 diabetes. [2010.06]
AIM: The aim of this study was to investigate how patients' expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction... CONCLUSION: Expectations may not independently impact treatment satisfaction, but the relationship with experiences significantly contributes to it. The EAITQ and EWITQ may be useful tools for clinicians to better understand patients' expectations about and experiences with insulin therapy.

Psychometric properties of an instrument for assessing the experience of patients treated with inhaled insulin: the inhaled insulin treatment questionnaire (IITQ). [2010.03.24]
BACKGROUND: Along with general measures of treatment satisfaction, treatment-specific and device-specific treatment satisfaction should be assessed in clinical trials, because these latter measures may be more strongly correlated with clinical outcomes... CONCLUSIONS -: Preliminary findings suggest that the IITQ is a comprehensive, reliable measure of the experience of patients treated with inhaled insulin.

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Clinical Trials Related to Exubera (Insulin Inhalation)

Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety [Completed]

Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus [Terminated]
This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).

Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents [Terminated]

Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes [Completed]
The current trial will examine the efficacy and safety of Exubera administered as a mealtime insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion of subjects to reach target glycosylated hemoglobin (A1C) levels.

A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus® [Completed]
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.

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