- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00287066
A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition
February 20, 2008 updated by: Pfizer
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
To assess the impact of inhalation of insulin on glucose disposition in patients with type 1 diabetes
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
22
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diabetes mellitus Type 1
Exclusion Criteria:
- Asthma, COPD
- Smoking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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18F-labeled glucose uptake in muscle
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Secondary Outcome Measures
Outcome Measure |
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Glucose turnover overnight Insulin pharmacokinetics
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
February 2, 2006
First Submitted That Met QC Criteria
February 2, 2006
First Posted (Estimate)
February 6, 2006
Study Record Updates
Last Update Posted (Estimate)
February 21, 2008
Last Update Submitted That Met QC Criteria
February 20, 2008
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A2171060
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Medical College of WisconsinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
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Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
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Brown UniversityRecruiting
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University of Sao PauloCompletedHeart Valve Diseases | Ventricular Dysfunction | Hyperglycaemia During Perioperative PeriodBrazil
-
Mannkind CorporationCompleted
-
Vanderbilt UniversityWithdrawn
-
WockhardtCompletedDiabetes MellitusUnited States
-
Halozyme TherapeuticsCompleted
-
Profil Institut für Stoffwechselforschung GmbHNovo Nordisk A/SCompleted