Diabetes Mellitus, Type 1
Conditions
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.
Interventions
Inhaled insulin with dose adjusted according to premeal blood glucose
DRUGSubcutaneous Insulin (subject's prescribed)
Subcutaneous insulin with dose adjusted according to premeal blood glucose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period | 12 months | No subjects were dosed therefore no data collected. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Treatment Preferences. | 12 months |
| Change From Baseline in FVC | 12 months |
| Slope for Other PFT Parameters; | 12 months |
| Change From Baseline in Other PFT Parameters | 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 |
| Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c | 12 months |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Inhaled Insulin (Exubera) No subjects received study medication. | 0 |
| Subcutaneous Insulin (Subject's Prescribed) No subjects received study medication. | 0 |
| Total | 0 |
Outcome results
Primary
To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period
No subjects were dosed therefore no data collected.
Time frame: 12 months
Population: No subjects were dosed therefore no participants for analysis.
Secondary
7 Point Home Glucose
Time frame: 12 months
Secondary
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
Secondary
Change From Baseline in FVC
Time frame: 12 months
Secondary
Change From Baseline in Insulin Antibodies (microU/mL);
Time frame: 12 months
Secondary
Change From Baseline in Other PFT Parameters
Time frame: 12 months
Secondary
Hypoglycemic Event Rates;
Time frame: 12 months
Secondary
Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c
Time frame: 12 months
Secondary
Slope for Other PFT Parameters;
Time frame: 12 months
Secondary
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
Secondary
Treatment Preferences.
Time frame: 12 months