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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 31, 2005
Last updated: March 9, 2008
Last verified: February 2007

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:

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

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

Inclusion Criteria:

  • Type 1 Diabetes Mellitus
  • Normal lung function

Exclusion Criteria:

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

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
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided 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, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on October 19, 2014