Clinical trial NCT00479258: Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 2
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period
timeFrame: 12 months
Secondary outcomes:
measure: Change From Baseline in Other PFT Parameters
timeFrame: 12 months
measure: Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;
timeFrame: 12 months
measure: Treatment Preferences.
timeFrame: 12 months
measure: Change From Baseline in FVC
timeFrame: 12 months
measure: Slope for Other PFT Parameters;
timeFrame: 12 months
measure: Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c
timeFrame: 12 months
measure: Change From Baseline in Insulin Antibodies (microU/mL);
timeFrame: 12 months
measure: Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;
timeFrame: 12 months
measure: Hypoglycemic Event Rates;
timeFrame: 12 months
measure: 7 Point Home Glucose
timeFrame: 12 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: