search
Back to results

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

Primary Purpose

Type 1 Diabetes, Type 2 Diabetes

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Technosphere Insulin Inhalation Powder
Sponsored by
Mannkind Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Type 1 Diabetes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endocrinology Associates
  • Diabetes and Endocrine Consultants P.C.
  • University of Miami Diabetes Research Institute
  • Dr. Rife and Associates Family Medicine
  • Highland Clini-Endocrinology
  • Annapolis Internal Medicine LLC
  • Nallin Family Healthcare
  • Center for Diabetes and Endocrinology
  • North Country Community Physicians
  • Great Neck Medical Group
  • North Shore Diabetes and Endocrine Associates
  • Mountain Diabetes and Endocrine Center
  • Primary Care Wakefield
  • Endocrinology Associates Inc.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 19, 2013
Last Updated
January 19, 2016
Sponsor
Mannkind Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01798914
Brief Title
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
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 Type
Expanded Access

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
No longer available
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mannkind Corporation

4. Oversight

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Type 2 Diabetes

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Technosphere Insulin Inhalation Powder
Other Intervention Name(s)
Afrezza Inhalation Powder
Intervention Description
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Endocrinology Associates
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Diabetes and Endocrine Consultants P.C.
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
University of Miami Diabetes Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Dr. Rife and Associates Family Medicine
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60467
Country
United States
Facility Name
Highland Clini-Endocrinology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Annapolis Internal Medicine LLC
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Nallin Family Healthcare
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Center for Diabetes and Endocrinology
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
North Country Community Physicians
City
Glen Cove
State/Province
New York
ZIP/Postal Code
11542
Country
United States
Facility Name
Great Neck Medical Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
North Shore Diabetes and Endocrine Associates
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Mountain Diabetes and Endocrine Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Primary Care Wakefield
City
Wakefield
State/Province
Rhode Island
ZIP/Postal Code
02879
Country
United States
Facility Name
Endocrinology Associates Inc.
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs