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

August 31, 2018 updated by: Pfizer

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.

To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14222
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

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
Time Frame: 12 months
No subjects were dosed therefore no data collected.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

May 24, 2007

First Submitted That Met QC Criteria

May 24, 2007

First Posted (Estimate)

May 28, 2007

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

August 31, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2171083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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