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

South Orange County Endocrinology

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Diabetes

Interventions

Technosphere® Insulin Inhalation SystemDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

South Orange County Endocrinology

Laguna Hills, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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