An interventional study of Technosphere® Insulin Inhalation System in Diabetes, sponsored by South Orange County Endocrinology. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by South Orange County Endocrinology · Not applicable, Interventional, and Treatment
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.
11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
Browse Diabetes Mellitus studies →This is the only study on the registry with South Orange County Endocrinology as lead sponsor.
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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.
Single Site, Single Subject use of Technosphere® Insulin Inhalation System
Drug: Technosphere® Insulin Inhalation System
Single Site, Single Subject use of Technosphere® Insulin Inhalation System
Efficacy of Inhaled Insulin versus Subcutaneous Insulin in a patient who receives inadequate response from subcutaneous alone.
Evaluate fasting plasma glucose and hemoglobin a1c
Time frame: 12-months
The record gives a start of May 2013, a primary completion of Oct 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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