Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Drug: Inhaled insulin (Exubera)
Drug: Subcutaneous Insulin (subject's prescribed)
Enrollment 2
Recruitment Details 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. Location = UNITED STATES.
Pre-assignment Details Pfizer announced in Oct 2007 that it would stop marketing Exubera. At that time recruitment was placed on hold. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. As a result, study A2171083 was terminated and no further recruitment took place.
Arm/Group Title Inhaled Insulin (Exubera) Subcutaneous Insulin (Subject's Prescribed)
Hide Arm/Group Description No subjects received study medication. No subjects received study medication.
Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Inhaled Insulin (Exubera) Subcutaneous Insulin (Subject's Prescribed) Total
Hide Arm/Group Description No subjects received study medication. No subjects received study medication. Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Unit of measure:  Subjects
Number Analyzed 0 participants 0 participants 0 participants
[1]
Measure Description: <18 years
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
1.Primary Outcome
Title To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period
Hide Description No subjects were dosed therefore no data collected.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were dosed therefore no participants for analysis.
Arm/Group Title Inhaled Insulin (Exubera) Subcutaneous Insulin (Subject's Prescribed)
Hide Arm/Group Description:
No subjects received study medication.
No subjects received study medication.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in Other PFT Parameters
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Treatment Preferences.
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change From Baseline in FVC
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Slope for Other PFT Parameters;
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Change From Baseline in Insulin Antibodies (microU/mL);
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Hypoglycemic Event Rates;
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
11.Secondary Outcome
Title 7 Point Home Glucose
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
Pfizer announced Oct07 it would stop marketing Exubera; recruitment placed on hold. Nektar, from which Pfizer licensed Exubera, announced April 9, 2008 it had stopped its search for a new marketing partner. Study terminated; no further recruitment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00479258     History of Changes
Other Study ID Numbers: A2171083
First Submitted: May 24, 2007
First Posted: May 28, 2007
Results First Submitted: October 29, 2008
Results First Posted: November 3, 2008
Last Update Posted: October 1, 2018