Eligibility criteria
Condition
Diabetes Mellitus
Sex
Females and Males
Age
18-50 years
Inclusion criteria
Show details
- Diabetes mellitus Type 1
Exclusion criteria
Show details
- Asthma, COPD
- Smoking
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A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition
NCT00287066
Last updated on November 16, 2019
About this Study
To assess the impact of inhalation of insulin on glucose disposition in patients with type 1 diabetes
NCT00287066
Pfizer
Terminated
A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition | |||
| Official Title ICMJE | 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 | |||
| 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Diabetes Mellitus | |||
| Intervention ICMJE |
| |||
| 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 | Terminated | |||
| Enrollment ICMJE | 22 | |||
| Original Enrollment ICMJE | 17 | |||
| Actual Study Completion Date ICMJE | March 2007 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 50 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| 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 | NCT00287066 | |||
| Other Study ID Numbers ICMJE | A2171060 | |||
| 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 | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2007 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
BY PHONE
Pfizer Clinical Trials Contact Center
1-800-718-1021