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

Phase 3TerminatedNCT00479258

Pfizer2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

Inhaled insulin (Exubera)DRUG

Inhaled insulin with dose adjusted according to premeal blood glucose

Subcutaneous Insulin (subject's prescribed)DRUG

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Buffalo, New York, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Change From Baseline in Other PFT Parameters

Time frame: 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;

Time frame: 12 months

Treatment Preferences.

Time frame: 12 months

Change From Baseline in FVC

Time frame: 12 months

Slope for Other PFT Parameters;

Time frame: 12 months

Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c

Time frame: 12 months

Change From Baseline in Insulin Antibodies (microU/mL);

Time frame: 12 months

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

Hypoglycemic Event Rates;

Time frame: 12 months

7 Point Home Glucose

Time frame: 12 months

Data from ClinicalTrials.gov

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