Status:
WITHDRAWN
Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere Inhalation System
Lead Sponsor:
South Orange County Endocrinology
Collaborating Sponsors:
Mannkind Corporation
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 thei...
Detailed Description
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 tre...
Eligibility Criteria
Inclusion
- Documented diagnosis with diabetes mellitus and have established a need for treatment with the investigational product.
- Local Ethics Committee approval has been documented, as needed. Patient has signed the Informed Consent Form for participation. Patient has successfully completed training on the Technosphere Insulin Inhalation System.
Exclusion
- Allergy to Insulin. Smoking in the previous 6-months. History of asthma or COPD or any other significant pulmonary disease, or exposure to pulmonary toxins.
- Clinical significant abnormality in screening laboratory tests. Positive pregnancy test or the intention to become pregnant. Women of childbearing age without appropriate method of contraception.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01459133
Start Date
May 1 2013
End Date
October 1 2014
Last Update
March 17 2015
Active Locations (1)
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1
South Orange County Endocrinology
Laguna Hills, California, United States, 92653