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See termination reason in detailed description.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled insulin (Exubera) | Experimental |
| |
| Subcutaneous Insulin (subject's prescribed) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled insulin (Exubera) | Drug | Inhaled insulin with dose adjusted according to premeal blood glucose |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period | No subjects were dosed therefore no data collected. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Other PFT Parameters | 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; | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Buffalo | New York | 14222 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Insulin (Exubera) | No subjects received study medication. |
| FG001 | Subcutaneous Insulin (Subject's Prescribed) | No subjects received study medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Insulin (Exubera) | No subjects received study medication. |
| BG001 | Subcutaneous Insulin (Subject's Prescribed) | No subjects received study medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | <18 years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period | No subjects were dosed therefore no data collected. | No subjects were dosed therefore no participants for analysis. | Posted | 12 months |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C473734 | Exubera |
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| Subcutaneous Insulin (subject's prescribed) | Drug | Subcutaneous insulin with dose adjusted according to premeal blood glucose |
|
| Treatment Preferences. |
| 12 months |
| Change From Baseline in FVC | 12 months |
| Slope for Other PFT Parameters; | 12 months |
| Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c | 12 months |
| Change From Baseline in Insulin Antibodies (microU/mL); | 12 months |
| Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin; | 12 months |
| Hypoglycemic Event Rates; | 12 months |
| 7 Point Home Glucose | 12 months |
| BG002 | Total | Total of all reporting groups |
| subjects |
| Sex: Female, Male |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Secondary | Change From Baseline in Other PFT Parameters | Not Posted | 12 months | Participants |
| Secondary | Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted; | Not Posted | 12 months | Participants |
| Secondary | Treatment Preferences. | Not Posted | 12 months | Participants |
| Secondary | Change From Baseline in FVC | Not Posted | 12 months | Participants |
| Secondary | Slope for Other PFT Parameters; | Not Posted | 12 months | Participants |
| Secondary | Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c | Not Posted | 12 months | Participants |
| Secondary | Change From Baseline in Insulin Antibodies (microU/mL); | Not Posted | 12 months | Participants |
| Secondary | Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin; | Not Posted | 12 months | Participants |
| Secondary | Hypoglycemic Event Rates; | Not Posted | 12 months | Participants |
| Secondary | 7 Point Home Glucose | Not Posted | 12 months | Participants |
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.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |