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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.
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
Intervention Model: Single Group Assignment
Masking: None (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   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Normal lung function

Exclusion Criteria:

  • Smokers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Identifier: NCT00143338     History of Changes
Other Study ID Numbers: A2171053
Study First Received: August 31, 2005
Last Updated: February 11, 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 18, 2017