Clincosm LogoSign in Get a demo

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

Sponsor
Mannkind Corporation (Industry)
Overall Status
No longer available
CT.gov ID
NCT01798914
Collaborator
(none)
14
Locations
78.9
Duration (Months)

Study Details

Study Description

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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.

Condition or Disease Intervention/Treatment Phase
  • Drug: Technosphere Insulin Inhalation Powder

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 Design

Study Type:
Expanded Access
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 Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
May 1, 2015

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Endocrinology Associates Montgomery Alabama United States 36106
    2 Diabetes and Endocrine Consultants P.C. Montgomery Alabama United States 36117
    3 University of Miami Diabetes Research Institute Miami Florida United States 33136
    4 Dr. Rife and Associates Family Medicine Orland Park Illinois United States 60467
    5 Highland Clini-Endocrinology Shreveport Louisiana United States 71105
    6 Annapolis Internal Medicine LLC Annapolis Maryland United States 21401
    7 Nallin Family Healthcare Cumberland Maryland United States 21502
    8 Center for Diabetes and Endocrinology Portsmouth New Hampshire United States 03801
    9 North Country Community Physicians Glen Cove New York United States 11542
    10 Great Neck Medical Group Great Neck New York United States 11021
    11 North Shore Diabetes and Endocrine Associates New Hyde Park New York United States 11042
    12 Mountain Diabetes and Endocrine Center Asheville North Carolina United States 28803
    13 Primary Care Wakefield Wakefield Rhode Island United States 02879
    14 Endocrinology Associates Inc. Roanoke Virginia United States 24016

    Sponsors and Collaborators

    • Mannkind Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mannkind Corporation
    ClinicalTrials.gov Identifier:
    NCT01798914
    Other Study ID Numbers:
    • MKC-TI-139
    First Posted:
    Feb 26, 2013
    Last Update Posted:
    Jan 20, 2016
    Last Verified:
    Jan 1, 2016
    Additional relevant MeSH terms:
    Respiratory Aspiration
    Diabetes Mellitus
    Insulin

    Study Results

    No Results Posted as of Jan 20, 2016