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

NCT00143104

Last updated date
Study Location
Pfizer Investigational Site
Glendale, Arizona, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 1 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Type 1 Diabetes Mellitus

- Normal lung function

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Smokers

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Advanced Information
Descriptive Information
Brief Title  ICMJE To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
Official Title  ICMJE 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.
Brief Summary To examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE Drug: Inhaled insulin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 31, 2005)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 1 Diabetes Mellitus
  • Normal lung function

Exclusion Criteria:

  • Smokers
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143104
Other Study ID Numbers  ICMJE A2171052
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP