Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
- Conditions
- Type 1 DiabetesType 2 Diabetes
- Registration Number
- NCT01798914
- Lead Sponsor
- Mannkind Corporation
- 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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.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
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Endocrinology Associates
🇺🇸Montgomery, Alabama, United States
Diabetes and Endocrine Consultants P.C.
🇺🇸Montgomery, Alabama, United States
Dr. Rife and Associates Family Medicine
🇺🇸Orland Park, Illinois, United States
Nallin Family Healthcare
🇺🇸Cumberland, Maryland, United States
Highland Clini-Endocrinology
🇺🇸Shreveport, Louisiana, United States
Center for Diabetes and Endocrinology
🇺🇸Portsmouth, New Hampshire, United States
North Country Community Physicians
🇺🇸Glen Cove, New York, United States
North Shore Diabetes and Endocrine Associates
🇺🇸New Hyde Park, New York, United States
Great Neck Medical Group
🇺🇸Great Neck, New York, United States
Mountain Diabetes and Endocrine Center
🇺🇸Asheville, North Carolina, United States
Primary Care Wakefield
🇺🇸Wakefield, Rhode Island, United States
Endocrinology Associates Inc.
🇺🇸Roanoke, Virginia, United States
Annapolis Internal Medicine LLC
🇺🇸Annapolis, Maryland, United States
University of Miami Diabetes Research Institute
🇺🇸Miami, Florida, United States