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

Type 2 Diabetes Clinical Trial

Official title:

Patient Transfer Program for Transitioning From Exubera® (Insulin Human [rDNA Origin]) Inhalation Powder to Technosphere® Insulin (Insulin Human [rDNA Origin]) Inhalation Powder

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01798914
• Other study ID #: MKC-TI-139
• Status: No longer available
• Phase: Phase 3
• First received: February 19, 2013
• Last updated: January 19, 2016
• Start date: October 2008
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.

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 information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Drug:
• Technosphere Insulin Inhalation Powder
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Country where clinical trial is conducted

United States,