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

Withdrawn before enrolling · Not applicable

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT01459133

Run by

South Orange County Endocrinology

People needed

0

Starts

2013-05-01

Expected to finish

2014-10-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• South Orange County Endocrinology — Laguna Hills, California, United States

Full record on ClinicalTrials.gov

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