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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798914
Expanded Access Status : No longer available
First Posted : February 26, 2013
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation

Study Description
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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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.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
Type 1 Diabetes Type 2 Diabetes 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
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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 : October 2008
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Technosphere Insulin Inhalation Powder
    Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
    Other Name: Afrezza Inhalation Powder
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798914


Locations
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United States, Alabama
Endocrinology Associates
Montgomery, Alabama, United States, 36106
Diabetes and Endocrine Consultants P.C.
Montgomery, Alabama, United States, 36117
United States, Florida
University of Miami Diabetes Research Institute
Miami, Florida, United States, 33136
United States, Illinois
Dr. Rife and Associates Family Medicine
Orland Park, Illinois, United States, 60467
United States, Louisiana
Highland Clini-Endocrinology
Shreveport, Louisiana, United States, 71105
United States, Maryland
Annapolis Internal Medicine LLC
Annapolis, Maryland, United States, 21401
Nallin Family Healthcare
Cumberland, Maryland, United States, 21502
United States, New Hampshire
Center for Diabetes and Endocrinology
Portsmouth, New Hampshire, United States, 03801
United States, New York
North Country Community Physicians
Glen Cove, New York, United States, 11542
Great Neck Medical Group
Great Neck, New York, United States, 11021
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, United States, 11042
United States, North Carolina
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States, 28803
United States, Rhode Island
Primary Care Wakefield
Wakefield, Rhode Island, United States, 02879
United States, Virginia
Endocrinology Associates Inc.
Roanoke, Virginia, United States, 24016
Sponsors and Collaborators
Mannkind Corporation
More Information
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Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01798914    
Other Study ID Numbers: MKC-TI-139
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Respiratory Aspiration
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiration Disorders
 Respiratory Tract Diseases
Pathologic Processes
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs