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

January 19, 2016 updated by: Mannkind Corporation

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

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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Endocrinology Associates
      • Montgomery, Alabama, United States, 36117
        • Diabetes and Endocrine Consultants P.C.
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Diabetes Research Institute
    • Illinois
      • Orland Park, Illinois, United States, 60467
        • Dr. Rife and Associates Family Medicine
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Highland Clini-Endocrinology
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Annapolis Internal Medicine LLC
      • Cumberland, Maryland, United States, 21502
        • Nallin Family Healthcare
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Center for Diabetes and Endocrinology
    • New York
      • Glen Cove, New York, United States, 11542
        • North Country Community Physicians
      • Great Neck, New York, United States, 11021
        • Great Neck Medical Group
      • New Hyde Park, New York, United States, 11042
        • North Shore Diabetes and Endocrine Associates
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Mountain Diabetes and Endocrine Center
    • Rhode Island
      • Wakefield, Rhode Island, United States, 02879
        • Primary Care Wakefield
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Endocrinology Associates Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mannkind Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKC-TI-139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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