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: February 11, 2008
Last verified: February 2008

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

Condition Intervention Phase
Diabetes Mellitus, Type 2
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 2 Diabetes Mellitus.

Resource links provided by NLM:

Further study details as provided by Pfizer:

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.

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: November 2004
Study Completion Date: December 2006

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Normal lung function

Exclusion Criteria:

  • Smokers
  Contacts and Locations
Please refer to this study by its identifier: NCT00143338

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: NCT00143338     History of Changes
Other Study ID Numbers: A2171053
Study First Received: August 31, 2005
Last Updated: February 11, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014