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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 2, 2008
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 24, 2007
First Posted Date  ICMJE May 28, 2007
Results First Submitted Date  ICMJE October 29, 2008
Results First Posted Date  ICMJE November 2, 2008
Last Update Posted Date October 1, 2018
Study Start Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2008)
To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period [ Time Frame: 12 months ]
No subjects were dosed therefore no data collected.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2007)
To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
  • Change From Baseline in Other PFT Parameters [ Time Frame: 12 months ]
  • 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 ]
  • Treatment Preferences. [ Time Frame: 12 months ]
  • Change From Baseline in FVC [ Time Frame: 12 months ]
  • Slope for Other PFT Parameters; [ Time Frame: 12 months ]
  • Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c [ Time Frame: 12 months ]
  • Change From Baseline in Insulin Antibodies (microU/mL); [ Time Frame: 12 months ]
  • 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 ]
  • Hypoglycemic Event Rates; [ Time Frame: 12 months ]
  • 7 Point Home Glucose [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2007)
  • Change From Baseline in FVC
  • Change From Baseline in Other PFT Parameters
  • Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;
  • Slope for Other PFT Parameters;
  • Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c
  • Change From Baseline in Insulin Antibodies (microU/mL);
  • Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;
  • Hypoglycemic Event Rates;
  • 7 Point Home Glucose
  • Treatment preferences
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents
Official Title  ICMJE 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.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Inhaled insulin (Exubera)
    Intervention: Drug: Inhaled insulin (Exubera)
  • Active Comparator: Subcutaneous Insulin (subject's prescribed)
    Intervention: Drug: Subcutaneous Insulin (subject's prescribed)
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
Actual Enrollment  ICMJE
 (submitted: August 31, 2018)
2
Original Enrollment  ICMJE
 (submitted: May 24, 2007)
554
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
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 NCT00479258
Other Study ID Numbers  ICMJE A2171083
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP