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

This study is not yet open for participant recruitment.
Verified February 2013 by South Orange County Endocrinology
Sponsor:
Collaborator:
Mannkind Corporation
Information provided by (Responsible Party):
South Orange County Endocrinology
ClinicalTrials.gov Identifier:
NCT01459133
First received: October 21, 2011
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
 Drug: Technosphere® Insulin Inhalation System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by South Orange County Endocrinology:

Estimated Enrollment: 1
Study Start Date: May 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Technosphere® Insulin Inhalation System
Single Site, Single Subject use of Technosphere® Insulin Inhalation System
 Drug: Technosphere® Insulin Inhalation System
Single Site, Single Subject use of Technosphere® Insulin Inhalation System

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459133

Locations
United States, California
South Orange County Endocrinology Not yet recruiting
Laguna Hills, California, United States, 92653
Contact: Justin K Deck     949-457-7900     research@socsurgeons.com    
Principal Investigator: Alan O Marcus, MD            
Sponsors and Collaborators
South Orange County Endocrinology
Mannkind Corporation
  More Information

No publications provided

Responsible Party: South Orange County Endocrinology
ClinicalTrials.gov Identifier: NCT01459133     History of Changes
Other Study ID Numbers: IND110021
Study First Received: October 21, 2011
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by South Orange County Endocrinology:
investigational
inhaled insulin product

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013