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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inhaled insulin (Exubera)

Group Type EXPERIMENTAL

Inhaled insulin (Exubera)

Intervention Type DRUG

Inhaled insulin with dose adjusted according to premeal blood glucose

Subcutaneous Insulin (subject's prescribed)

Group Type ACTIVE_COMPARATOR

Subcutaneous Insulin (subject's prescribed)

Intervention Type DRUG

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Interventions

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Inhaled insulin (Exubera)

Inhaled insulin with dose adjusted according to premeal blood glucose

Intervention Type DRUG

Subcutaneous Insulin (subject's prescribed)

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Intervention Type DRUG

Eligibility Criteria

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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.