NCT01459133

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.4 years

First QC Date

October 21, 2011

Last Update Submit

March 10, 2015

Conditions

Diabetes

Keywords

investigationalinhaled insulin product

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Technosphere® Insulin Inhalation System

EXPERIMENTAL

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

Drug: Technosphere® Insulin Inhalation System

Interventions

Technosphere® Insulin Inhalation SystemDRUG

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

Technosphere® Insulin Inhalation System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Orange County Endocrinology

Laguna Hills, California, 92653, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2011

First Posted

October 25, 2011

Study Start

May 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

US(1)