Trial record 1 of 1 for: NCT00287066

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A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition

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ClinicalTrials.gov Identifier: NCT00287066

Recruitment Status : Terminated (See termination reason in detailed description.)

First Posted : February 6, 2006

Last Update Posted : February 21, 2008

Sponsor:

Information provided by:

Pfizer

Tracking Information

First Submitted Date ^ICMJE

February 2, 2006

First Posted Date ^ICMJE

February 6, 2006

Last Update Posted Date

February 21, 2008

Study Start Date ^ICMJE

February 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

18F-labeled glucose uptake in muscle

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Glucose turnover overnight Insulin pharmacokinetics

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

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

Drug: Inhaled Human Insulin
Drug: Regular Human 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

Terminated

Enrollment ^ICMJE

Original Enrollment ^ICMJE

Actual Study Completion Date ^ICMJE

March 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diabetes mellitus Type 1

Exclusion Criteria:

Asthma, COPD
Smoking

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

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

Study Director:

Pfizer CT.gov Call Center

Pfizer

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

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