Clinical trial NCT01798914: Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
Official title: Patient Transfer Program for Transitioning From Exubera® (Insulin Human [rDNA Origin]) Inhalation Powder to Technosphere® Insulin (Insulin Human [rDNA Origin]) Inhalation Powder
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2013-02-26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Endocrinology Associates
state: Alabama
city: Montgomery
country: United States
facility: Diabetes and Endocrine Consultants P.C.
state: Alabama
city: Miami
country: United States
facility: University of Miami Diabetes Research Institute
state: Florida
city: Orland Park
country: United States
facility: Dr. Rife and Associates Family Medicine
state: Illinois
city: Shreveport
country: United States
facility: Highland Clini-Endocrinology
state: Louisiana
city: Annapolis
country: United States
facility: Annapolis Internal Medicine LLC
state: Maryland
city: Cumberland
country: United States
facility: Nallin Family Healthcare
state: Maryland
city: Portsmouth
country: United States
facility: Center for Diabetes and Endocrinology
state: New Hampshire
city: Glen Cove
country: United States
facility: North Country Community Physicians
state: New York
city: Great Neck
country: United States
facility: Great Neck Medical Group
state: New York
city: New Hyde Park
country: United States
facility: North Shore Diabetes and Endocrine Associates
state: New York
city: Asheville
country: United States
facility: Mountain Diabetes and Endocrine Center
state: North Carolina
city: Wakefield
country: United States
facility: Primary Care Wakefield
state: Rhode Island
city: Roanoke
country: United States
facility: Endocrinology Associates Inc.
state: Virginia
Study officials:
References: