Comprehensive Pulmonary Safety Review of Inhaled Technosphere^® Insulin in Patients with Diabetes Mellitus.

ABSTRACT:

Background and objective

Technosphere^® Insulin (TI), a human insulin powder for inhalation (Afrezza^®; MannKind Corporation, Westlake Village, CA, USA), is an ultra-rapid-acting inhaled insulin indicated to improve postprandial glycemic control in patients with type 1 or type 2 diabetes mellitus (T1DM or T2DM). Because TI is absorbed across the alveolar membrane, the objective of this analysis was to characterize its pulmonary safety.

Methods

Pooled data from 13 phase 2/3 clinical studies in 5505 patients with T1DM or T2DM treated with TI, Technosphere inhalation powder without insulin (TP; placebo), or active-comparator treatment were analyzed for incidences of respiratory treatment-emergent adverse events (TEAEs), changes in pulmonary function, and lun

SUBMITTER: McGill JB 

PROVIDER: S-EPMC7511468 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature