Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder

NO_LONGER_AVAILABLE

Conditions studied: Type 1 Diabetes, Type 2 Diabetes

In brief

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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.

Key facts

Study ID

NCT01798914

Run by

Mannkind Corporation

Starts

2008-10-01

Expected to finish

2015-05-01

Last updated by the study team

2016-01-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Endocrinology Associates — Montgomery, Alabama, United States
• Diabetes and Endocrine Consultants P.C. — Montgomery, Alabama, United States
• University of Miami Diabetes Research Institute — Miami, Florida, United States
• Dr. Rife and Associates Family Medicine — Orland Park, Illinois, United States
• Highland Clini-Endocrinology — Shreveport, Louisiana, United States
• Annapolis Internal Medicine LLC — Annapolis, Maryland, United States
• Nallin Family Healthcare — Cumberland, Maryland, United States
• Center for Diabetes and Endocrinology — Portsmouth, New Hampshire, United States
• North Country Community Physicians — Glen Cove, New York, United States
• Great Neck Medical Group — Great Neck, New York, United States
• North Shore Diabetes and Endocrine Associates — New Hyde Park, 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

Full record on ClinicalTrials.gov

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