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Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Buffalo, New York, 14222 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 1 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with Type 1 diabetes mellitus for more than 6 months.

- Males and females ages 6 to 17 years.

- Subjects should be receiving, or be able to tolerate, at a minimum a 3 unit pre
prandial dose of short acting subcutaneous insulin.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects using an insulin pump

- Smoking

NCT00479258
Pfizer
Terminated
Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents

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Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents
Safety And Efficacy Of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents Ages 6-17 Years With Type 1 Diabetes Mellitus: A 12 Month, Outpatient, Randomized, Open Label, Parallel Group Comparative Trial.
To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period.
Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for the pediatric study, A2171083, was placed on hold. Two subjects completed the informed consent/assent process and entered the A2171083 study but none received treatment. The first subject withdrew consent during the Baseline Run-in period which was prior to Randomization. The second subject screen failed at Visit 1. After this time, Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171083 was terminated and no further recruitment took place.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Drug: Inhaled insulin (Exubera)
    Inhaled insulin with dose adjusted according to premeal blood glucose
  • Drug: Subcutaneous Insulin (subject's prescribed)
    Subcutaneous insulin with dose adjusted according to premeal blood glucose
  • Experimental: Inhaled insulin (Exubera)
    Intervention: Drug: Inhaled insulin (Exubera)
  • Active Comparator: Subcutaneous Insulin (subject's prescribed)
    Intervention: Drug: Subcutaneous Insulin (subject's prescribed)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
554
October 2007
October 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with Type 1 diabetes mellitus for more than 6 months.
  • Males and females ages 6 to 17 years.
  • Subjects should be receiving, or be able to tolerate, at a minimum a 3 unit pre prandial dose of short acting subcutaneous insulin.

Exclusion Criteria:

  • Subjects using an insulin pump
  • Smoking
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00479258
A2171083
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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