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

• Sponsor: South Orange County Endocrinology (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01459133
• Collaborator: Mannkind Corporation (Industry)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 17
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: Technosphere® Insulin Inhalation System	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere
• Study Start Date: May 1, 2013
• Anticipated Primary Completion Date: Oct 1, 2014
• Anticipated Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Efficacy of Inhaled Insulin versus Subcutaneous Insulin in a patient who receives inadequate response from subcutaneous alone. [12-months]

   Evaluate fasting plasma glucose and hemoglobin a1c

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	South Orange County Endocrinology	Laguna Hills	California	United States	92653

Sponsors and Collaborators

• South Orange County Endocrinology
• Mannkind Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: South Orange County Endocrinology
• ClinicalTrials.gov Identifier: NCT01459133
• Other Study ID Numbers: IND110021
• First Posted: Oct 25, 2011
• Last Update Posted: Mar 17, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by South Orange County Endocrinology: investigational; inhaled insulin product
• Additional relevant MeSH terms: Insulin

Study Results

No Results Posted as of Mar 17, 2015