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

S

South Orange County Endocrinology

Status

Withdrawn

Conditions

Diabetes

Treatments

Drug: Technosphere® Insulin Inhalation System

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01459133
IND110021

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Technosphere® Insulin Inhalation System
Experimental group
Description:
Single Site, Single Subject use of Technosphere® Insulin Inhalation System
Treatment:
Drug: Technosphere® Insulin Inhalation System

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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