Diabetes
Conditions
Keywords
investigational, inhaled insulin product
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.
Interventions
DRUGTechnosphere® Insulin Inhalation System
Single Site, Single Subject use of Technosphere® Insulin Inhalation System
Sponsors
Mannkind Corporation
South Orange County Endocrinology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Inhaled Insulin versus Subcutaneous Insulin in a patient who receives inadequate response from subcutaneous alone. | 12-months | Evaluate fasting plasma glucose and hemoglobin a1c |
Countries
United States
Outcome results
None listed