NCT Number: NCT00143104
To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
To examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Pfizer Investigational Site, Glendale, Arizona, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Type 1 Diabetes Mellitus
- Normal lung function
Exclusion criteria
- Smokers
Treatment and study plan
Primary outcomes
-
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 outcomes
-
(1) Albumin and fibrinogen concentrations, and airway appearance in the above subjects. (2) routine safety, tolerance, and efficacy in the above subjects.
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Lead sponsor
Pfizer
Industry
Collaborators
- Sanofi
Registry information
Official study 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.
Important dates
- Study start
- 2004
- Study completion
- 2006
- First posted
- Sep 2, 2005
- Registry last updated
- Mar 11, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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