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Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere
The purpose of this program is to allow patients with diabetes and with specific medical needs which require them to use this investigational inhaled insulin product in order to adequately manage their diabetes. Treatment use of this investigational product is only anticipated when exceptional need is identified by a treating physician on a per patient case by case review.
This program is for patients who have been diagnosed with diabetes mellitus and has established a need for treatment with this investigational product documented by a health care professional. The treating doctor, or a member of his/her staff, will discuss the specific requirements for participation with the subject. INVESTIGATIONAL PRODUCT DESCRIPTION: Technosphere® Insulin Inhalation System includes Technosphere® Insulin Inhalation Powder and inhaler. The Inhalation Powder comes in 10 unit and 20 unit cartridges.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
South Orange County Endocrinology
Laguna Hills, California, United States
Start Date
May 1, 2013
Primary Completion Date
October 1, 2014
Completion Date
October 1, 2014
Last Updated
March 17, 2015
Technosphere® Insulin Inhalation System
DRUG
Lead Sponsor
South Orange County Endocrinology
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07296484