Back to resultsTo Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inhaled insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria: Type 1 Diabetes Mellitus Normal lung function Exclusion Criteria: Smokers
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
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 Outcome Measures
(1) Albumin and fibrinogen concentrations, and airway appearance in the above subjects. (2) routine safety, tolerance, and efficacy in the above subjects.
Full Information
NCT ID
NCT00143104
First Posted
August 31, 2005
Last Updated
March 9, 2008
Sponsor
Pfizer
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00143104
Brief Title
To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
Collaborators
Sanofi
4. Oversight
5. Study Description
Brief Summary
To examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Inhaled insulin
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
(1) Albumin and fibrinogen concentrations, and airway appearance in the above subjects. (2) routine safety, tolerance, and efficacy in the above subjects.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 Diabetes Mellitus
Normal lung function
Exclusion Criteria:
Smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Fresno
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171052&StudyName=To+Examine+the+Lung+When+People+with+Diabetes+Take+an+Inhaled+Form+of+Insulin%2C+Compared+to+Subcutaneous+Insulin%2E
Description
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Learn more about this trial
To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
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