Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere Inhalation System

Study Overview
=================
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 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.

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 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.

Official Title
-----------------
Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Technosphere® Insulin Inhalation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technosphere® Insulin Inhalation System<br>Single Site, Single Subject use of Technosphere® Insulin Inhalation System | Drug: Technosphere® Insulin Inhalation System<br>* Single Site, Single Subject use of Technosphere® Insulin Inhalation System<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Inhaled Insulin versus Subcutaneous Insulin in a patient who receives inadequate response from subcutaneous alone. | Evaluate fasting plasma glucose and hemoglobin a1c | 12-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
investigational, inhaled insulin product