Diabetes Clinical Trial
Official title:
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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