Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin 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 continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn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