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NCT00143338 Clinical Trial

To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.

Diabetes Mellitus, Type 2 Clinical Trial

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 2 Diabetes Mellitus.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143338
Other study ID # A2171053
Secondary ID
Status Completed
Phase Phase 2
First received August 31, 2005
Last updated February 11, 2008
Start date November 2004
Est. completion date December 2006

Study information
Verified date February 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 55 Years
Eligibility Inclusion Criteria:

- Type 2 Diabetes Mellitus

- Normal lung function

Exclusion Criteria:

- Smokers

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Inhaled insulin

Locations
Country Name City State
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site San Antonio Texas

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Sanofi

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess in patients with type 2 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 (1) Albumin and fibrinogen concentrations, and airway appearance in the above subjects. (2) routine safety, tolerance, and efficacy in the above subjects.
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