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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Technosphere® Insulin Inhalation System

Single Site, Single Subject use of Technosphere® Insulin Inhalation System

Group Type EXPERIMENTAL

Technosphere® Insulin Inhalation System

Intervention Type DRUG

Single Site, Single Subject use of Technosphere® Insulin Inhalation System

Interventions

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Technosphere® Insulin Inhalation System

Single Site, Single Subject use of Technosphere® Insulin Inhalation System

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No