Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder

Status:	No longer available
Conditions:	Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	Any
Updated:	4/21/2016
Start Date:	October 2008
End Date:	May 2015

Patient Transfer Program for Transitioning From Exubera® (Insulin Human [rDNA Origin]) Inhalation Powder to Technosphere® Insulin (Insulin Human [rDNA Origin]) Inhalation Powder

The purpose of this study is to allow patients with specific needs for inhaled insulin to
continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn
from the market.

A Phase 3, open label, multicenter, safety follow up trial to convert the treatment of
subjects currently using Exubera to treatment with TI Inhalation Powder

Inclusion Criteria:

- Subject has type 1 or type 2 diabetes mellitus and is currently being treated with or
has been treated with Exubera.

- Subject has a severe phobia to sc injections of insulin (needle phobia) preventing
conventional treatment OR has impaired sc insulin absorption

Exclusion Criteria:

- Smoking in the previous 6 months

- History of asthma or chronic obstructive pulmonary disease (COPD) or any other
significant pulmonary disease, or exposure to pulmonary toxins.

- Clinically significant pulmonary abnormalities on chest high-resolution computed
tomography (HRCT).

- PFT results prior to transferring to TI Inhalation Powder showing any of the
following: FEV1 < 70% of predicted, FVC < 70% of predicted, DLCO < 70% of predicted,
TLC < 80% of predicted.

- Allergy to insulin

We found this trial at

sites

Endocrinology Associates Inc.

Roanoke, Virginia 24016

from

Roanoke, VA