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

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ClinicalTrials.gov Identifier: NCT00479258
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : May 28, 2007
Results First Posted : November 3, 2008
Last Update Posted : November 3, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Inhaled insulin (Exubera) Drug: Subcutaneous Insulin (subject's prescribed) Phase 3

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 554 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2007
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Inhaled insulin (Exubera) Drug: Inhaled insulin (Exubera)
Inhaled insulin with dose adjusted according to premeal blood glucose
Active Comparator: Subcutaneous Insulin (subject's prescribed) Drug: Subcutaneous Insulin (subject's prescribed)
Subcutaneous insulin with dose adjusted according to premeal blood glucose


Outcome Measures

Primary Outcome Measures :
  1. To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change From Baseline in Other PFT Parameters [ Time Frame: 12 months ]
  2. Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted; [ Time Frame: 12 months ]
  3. Change From Baseline in FVC [ Time Frame: 12 months ]
  4. Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c [ Time Frame: 12 months ]
  5. Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin; [ Time Frame: 12 months ]
  6. Hypoglycemic Event Rates; [ Time Frame: 12 months ]
  7. Treatment Preferences. [ Time Frame: 12 months ]
  8. Slope for Other PFT Parameters; [ Time Frame: 12 months ]
  9. Change From Baseline in Insulin Antibodies (microU/mL); [ Time Frame: 12 months ]
  10. 7 Point Home Glucose [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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): NCT00479258


Locations
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14222
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00479258     History of Changes
Other Study ID Numbers: A2171083
First Posted: May 28, 2007    Key Record Dates
Results First Posted: November 3, 2008
Last Update Posted: November 3, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs