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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

Brief Summary:
To assess the impact of inhalation of insulin on glucose disposition in patients with type 1 diabetes

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Inhaled Human Insulin Drug: Regular Human Insulin Phase 3

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  (Clinical Trial)
Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 18F-labeled glucose uptake in muscle

Secondary Outcome Measures :
  1. Glucose turnover overnight Insulin pharmacokinetics


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diabetes mellitus Type 1

Exclusion Criteria:

  • Asthma, COPD
  • Smoking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287066


Locations
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
ClinicalTrials.gov Identifier: NCT00287066     History of Changes
Other Study ID Numbers: A2171060
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: February 21, 2008
Last Verified: April 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs