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

Study Overview
=================
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.

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.

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Inhaled insulin (Exubera)
* Drug: Subcutaneous Insulin (subject's prescribed)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled insulin (Exubera)<br> | Drug: Inhaled insulin (Exubera)<br>* Inhaled insulin with dose adjusted according to premeal blood glucose<br>|
| Active Comparator: Subcutaneous Insulin (subject's prescribed)<br> | Drug: Subcutaneous Insulin (subject's prescribed)<br>* Subcutaneous insulin with dose adjusted according to premeal blood glucose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |