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

March 9, 2008 updated by: Pfizer

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States
        • Pfizer Investigational Site
    • California
      • Fresno, California, United States
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 Diabetes Mellitus
  • Normal lung function

Exclusion Criteria:

  • Smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

March 11, 2008

Last Update Submitted That Met QC Criteria

March 9, 2008

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2171052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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