Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
Patient Transfer Program for Transitioning From Exubera® (Insulin Human [rDNA Origin]) Inhalation Powder to Technosphere® Insulin (Insulin Human [rDNA Origin]) Inhalation Powder
1 other identifier
expanded_access
N/A
1 country
14
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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2008
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 19, 2013
CompletedFirst Posted
Study publicly available on registry
February 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJanuary 20, 2016
January 1, 2016
6.5 years
February 19, 2013
January 19, 2016
Conditions
Interventions
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Endocrinology Associates
Montgomery, Alabama, 36106, United States
Diabetes and Endocrine Consultants P.C.
Montgomery, Alabama, 36117, United States
University of Miami Diabetes Research Institute
Miami, Florida, 33136, United States
Dr. Rife and Associates Family Medicine
Orland Park, Illinois, 60467, United States
Highland Clini-Endocrinology
Shreveport, Louisiana, 71105, United States
Annapolis Internal Medicine LLC
Annapolis, Maryland, 21401, United States
Nallin Family Healthcare
Cumberland, Maryland, 21502, United States
Center for Diabetes and Endocrinology
Portsmouth, New Hampshire, 03801, United States
North Country Community Physicians
Glen Cove, New York, 11542, United States
Great Neck Medical Group
Great Neck, New York, 11021, United States
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, 11042, United States
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803, United States
Primary Care Wakefield
Wakefield, Rhode Island, 02879, United States
Endocrinology Associates Inc.
Roanoke, Virginia, 24016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2013
First Posted
February 26, 2013
Study Start
October 1, 2008
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
January 20, 2016
Record last verified: 2016-01