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Trial record 29 of 47 for:    mannkind

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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01798914
First received: February 19, 2013
Last updated: January 19, 2016
Last verified: January 2016
  Purpose
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needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.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 Intervention Phase
Type 1 Diabetes
Type 2 Diabetes
Drug: Technosphere Insulin Inhalation Powder
Phase 3

Study Type: Expanded Access     What is 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

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Study Start Date: October 2008
Study Completion Date: May 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Technosphere Insulin Inhalation Powder
    Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
    Other Name: Afrezza 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
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798914

Locations
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

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01798914     History of Changes
Other Study ID Numbers: MKC-TI-139
Study First Received: February 19, 2013
Last Updated: January 19, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Respiratory Aspiration
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 22, 2017