Overview
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
Status:
No longer available
No longer available
Trial end date:
2015-05-01
2015-05-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Mannkind CorporationTreatments:
Insulin
Insulin, Globin Zinc
Criteria
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