Status:
NO_LONGER_AVAILABLE
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
Lead Sponsor:
Mannkind Corporation
Conditions:
Type 1 Diabetes
Type 2 Diabetes
Eligibility:
All Genders
Brief 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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.
Detailed Description
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
EXPANDED_ACCESS
End Date :
May 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01798914
Start Date
October 1 2008
End Date
May 1 2015
Last Update
January 20 2016
Active Locations (14)
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1
Endocrinology Associates
Montgomery, Alabama, United States, 36106
2
Diabetes and Endocrine Consultants P.C.
Montgomery, Alabama, United States, 36117
3
University of Miami Diabetes Research Institute
Miami, Florida, United States, 33136
4
Dr. Rife and Associates Family Medicine
Orland Park, Illinois, United States, 60467