Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere Inhalation System
- Conditions
- Diabetes
- Interventions
- Drug: Technosphere® Insulin Inhalation System
- Registration Number
- NCT01459133
- Lead Sponsor
- South Orange County Endocrinology
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Technosphere® Insulin Inhalation System Technosphere® Insulin Inhalation System Single Site, Single Subject use of Technosphere® Insulin Inhalation System
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
South Orange County Endocrinology
🇺🇸Laguna Hills, California, United States