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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01459133
• Other study ID #: IND110021
• Status: Withdrawn
• Phase: N/A
• First received: October 21, 2011
• Last updated: March 10, 2015
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: South Orange County Endocrinology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Technosphere® Insulin Inhalation System
Single Site, Single Subject use of Technosphere® Insulin Inhalation System

Locations

Country	Name	City	State
United States	South Orange County Endocrinology	Laguna Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
South Orange County Endocrinology	Mannkind Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Inhaled Insulin versus Subcutaneous Insulin in a patient who receives inadequate response from subcutaneous alone.	Evaluate fasting plasma glucose and hemoglobin a1c	12-months	No