Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks

Summary

The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.

Timeline

Start

2008-05

Primary completion

2009-11

Completion

2010-03

Outcome

Met primary endpoint

Stopped: “Sponsor stopped development of the MedTone inhaler in favor of an improved device (Gen2 inhaler)”

release “Results of the primary endpoints, which show that AFREZZA is clearly non-inferior to standard therapy insulin lispro combined with basal insulin in reducing HbA1c levels” mannkindcorp.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin Lispro	Protein / enzyme biologic	—	—
Subject	Technosphere Insulin	Protein / enzyme biologic	15 iu	Inhaled
Subject	Technosphere Insulin	Protein / enzyme biologic	30 iu	Inhaled
Background	insulin glargine	Protein / enzyme biologic	—	Other

Indications