To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
A Phase 2, Exploratory Study to Examine the Effects of Inhaled Insulin, Compared With Subcutaneously Administered Insulin, on Airway Lining Fluid Composition in Subjects With Type 1 Diabetes Mellitus.
1 other identifier
interventional
20
1 country
3
Brief Summary
To examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2004
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedMarch 11, 2008
February 1, 2007
August 31, 2005
March 9, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
To assess in patients with type 1 diabetes mellitus the effects, if any, on lung lining, fluid cell count and differential within subjects after 12 weeks of inhaled insulin therapy compared to 12 weeks of subcutaneous short-acting therapy.
Secondary Outcomes (1)
(1) Albumin and fibrinogen concentrations, and airway appearance in the above subjects. (2) routine safety, tolerance, and efficacy in the above subjects.
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 Diabetes Mellitus
- Normal lung function
You may not qualify if:
- Smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Pfizer Investigational Site
Glendale, Arizona, United States
Pfizer Investigational Site
Fresno, California, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
December 1, 2004
Study Completion
October 1, 2006
Last Updated
March 11, 2008
Record last verified: 2007-02