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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143104
First received: August 31, 2005
Last updated: March 9, 2008
Last verified: February 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: Inhaled insulin
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

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.

Estimated Enrollment: 20
Study Start Date: December 2004
Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 Diabetes Mellitus
  • Normal lung function

Exclusion Criteria:

  • Smokers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143104

Locations
United States, Arizona
Pfizer Investigational Site
Glendale, Arizona, United States
United States, California
Pfizer Investigational Site
Fresno, California, United States
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States
Sponsors and Collaborators
Pfizer
Sanofi
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00143104     History of Changes
Other Study ID Numbers: A2171052
Study First Received: August 31, 2005
Last Updated: March 9, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013