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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 31, 2005

Last Updated Date

February 11, 2008

Start Date ^†

November 2004

Current Primary Outcome Measures ^†

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.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00143338 on ClinicalTrials.gov Archive Site

Current 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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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 2 Diabetes Mellitus.

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Diabetes Mellitus, Type 2

Intervention ^†

Drug: Inhaled insulin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Type 2 Diabetes Mellitus
Normal lung function

Exclusion Criteria:

Smokers

Gender

Both

Ages

30 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00143338

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Sanofi-Aventis

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.