Date of Graduation

Summer 8-9-2014

Degree Type

Capstone Project

Degree Name

Master of Science in Physician Assistant Studies

Abstract

Background: Insulin therapy is often met with apprehension among diabetic patients due to the inconvenience and discomfort of injecting oneself. Past attempts to develop an inhaled insulin has been met with such obstacles as inefficiency, cost issues, and patient acceptance. Technosphere® insulin (MannKind Corporation, Valencia, CA) is a rapid acting inhalable insulin that is indicated for prandial use and is currently in phase III clinical trials. It is showing promising results and this systematic review aims to evaluate the efficacy of Technosphere insulin as compared to traditional injectable insulin.

Methods: An exhaustive search was conducted using Medline-OVID, CINAHL, EBMR Multifile, and Web of Science with the key terms: Technosphere®, Afresa®, and Afrezza® for relevant studies. A search on the MannKind Corp. website was conducted for additional articles and data. Selected articles were assessed for quality using GRADE.

Results: Two studies met inclusion criteria and were included in this systematic review.

The first study is a randomized controlled trial that demonstrated the use of prandial inhaled Technosphere insulin to be non-inferior to injectable biaspart insulin in terms of HbA1c lowering capacity. In addition, patients treated with Technosphere insulin experienced fewer hypoglycemic episodes, less weight gain, and increased patient satisfaction. The second study is a randomized controlled trial that compares the pharmacokinetic profile of Technosphere insulin to that of regular human insulin. Technosphere insulin was found to have a significantly higher maximum concentration (Cmax), faster onset of action (tmax), and a quicker elimination (t1/2) compared to that of regular human insulin.

Conclusion: Inhaled Technosphere insulin was shown to be non-inferior to injectable biaspart insulin in terms of HbA1c lowering capacity and has a pharmacokinetic profile similar to that of other rapid acting insulins. Technosphere insulin was also found to be associated with less weight gain, fewer hypoglycemic episodes, and greater patient satisfaction. Although not currently FDA approved, Technosphere insulin seems to be a viable alternative to prandial injectable insulin.

Keywords: Technosphere, Technosphere insulin, inhaled insulin, insulin therapy

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