Back to resultsA Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition
Primary Purpose
Diabetes Mellitus
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Inhaled Human Insulin
Regular Human Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: Diabetes mellitus Type 1 Exclusion Criteria: Asthma, COPD Smoking
Sites / Locations
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
18F-labeled glucose uptake in muscle
Secondary Outcome Measures
Glucose turnover overnight Insulin pharmacokinetics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00287066
Brief Title
A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition
Official Title
Open-Label Randomized Two-Way Crossover Pilot Study To Estimate The Effects Of Inhaled Versus IV Infusion Of Human Insulin With Regards To Glucose Disposal In Subjects With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To assess the impact of inhalation of insulin on glucose disposition in patients with type 1 diabetes
Detailed Description
The study was terminated on Oct. 28, 2007. The protocol was undergoing implementation and methodological issues with major revisions that qualified this trial as a new trial. Pfizer decided to cancel new trials because of the decision to withdraw Exubera due to lack of market performance and not for safety reasons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Inhaled Human Insulin
Intervention Type
Drug
Intervention Name(s)
Regular Human Insulin
Primary Outcome Measure Information:
Title
18F-labeled glucose uptake in muscle
Secondary Outcome Measure Information:
Title
Glucose turnover overnight Insulin pharmacokinetics
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diabetes mellitus Type 1
Exclusion Criteria:
Asthma, COPD
Smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171060&StudyName=A+Clinical+Trial+Assessing+the+Impact+of+Inhaled+Insulin+on+Glucose+Disposition
Description
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Learn more about this trial
A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition
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