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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Inhaled insulin (Exubera)

Subcutaneous Insulin (subject's prescribed)

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhaled insulin (Exubera)

Subcutaneous Insulin (subject's prescribed)

Arm Description

Outcomes

Primary Outcome Measures

To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period

No subjects were dosed therefore no data collected.

Secondary Outcome Measures

Change From Baseline in Other PFT Parameters

Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;

Treatment Preferences.

Change From Baseline in FVC

Slope for Other PFT Parameters;

Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c

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

Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;

Hypoglycemic Event Rates;

7 Point Home Glucose

Full Information

NCT ID

NCT00479258

First Posted

May 24, 2007

Last Updated

August 31, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00479258

Brief Title

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

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

October 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inhaled insulin (Exubera)

Arm Type

Experimental

Arm Title

Subcutaneous Insulin (subject's prescribed)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Inhaled insulin (Exubera)

Intervention Description

Inhaled insulin with dose adjusted according to premeal blood glucose

Intervention Type

Drug

Intervention Name(s)

Subcutaneous Insulin (subject's prescribed)

Intervention Description

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Primary Outcome Measure Information:

Title

To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period

Description

No subjects were dosed therefore no data collected.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change From Baseline in Other PFT Parameters

Time Frame

12 months

Title

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

Title

Treatment Preferences.

Time Frame

12 months

Title

Change From Baseline in FVC

Time Frame

12 months

Title

Slope for Other PFT Parameters;

Time Frame

12 months

Title

Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c

Time Frame

12 months

Title

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

Time Frame

12 months

Title

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

Title

Hypoglycemic Event Rates;

Time Frame

12 months

Title

7 Point Home Glucose

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14222

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171083&StudyName=Safety%20And%20Efficacy%20Of%20Exubera%20Compared%20With%20Subcutaneous%20Human%20Insulin%20Therapy%20In%20Children%20And%20Adolescents

Description

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

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