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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT00143104
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Study Completion: 2006-10
• Status Verified: 2007-02
• Last Update Submitted: 2008-03-09
• Last Update Posted: 2008-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Type 1 Diabetes Mellitus
• Normal lung function

Exclusion Criteria

• Smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
(1) Albumin and fibrinogen concentrations, and airway appearance in the above subjects. (2) routine safety, tolerance, and efficacy in the above subjects.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 San Antonio, Texas, United States