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

Phase 3

Terminated

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Inhaled insulin (Exubera); Drug: Subcutaneous Insulin (subject's prescribed)

• Registration Number: NCT00479258
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-24
• Study First Posted: 2007-05-28
• Study Start: 2007-10
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Results First Submitted: 2008-10-29
• Results First Submitted QC: 2008-10-31
• Results First Posted: 2008-11-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-31
• Last Update Posted: 2018-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

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Exclusion Criteria

• Subjects using an insulin pump
• Smoking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled insulin (Exubera)	Inhaled insulin (Exubera)	-
Subcutaneous Insulin (subject's prescribed)	Subcutaneous Insulin (subject's prescribed)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Change From Baseline in FVC	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
7 Point Home Glucose	12 months
Slope for Other PFT Parameters;	12 months
Hypoglycemic Event Rates;	12 months
Change From Baseline in Other PFT Parameters	12 months
Treatment Preferences.	12 months
Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c	12 months
Change From Baseline in Insulin Antibodies (microU/mL);	12 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Buffalo, New York, United States