Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00479258

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: Inhaled insulin (Exubera) Drug: Subcutaneous Insulin (subject's prescribed)	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change From Baseline in Other PFT Parameters [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Change From Baseline in FVC [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Hypoglycemic Event Rates; [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Treatment Preferences. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Slope for Other PFT Parameters; [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Change From Baseline in Insulin Antibodies (microU/mL); [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
7 Point Home Glucose [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	554
Study Start Date:	October 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Inhaled insulin (Exubera): Experimental	Drug: Inhaled insulin (Exubera) Inhaled insulin with dose adjusted according to premeal blood glucose
Subcutaneous Insulin (subject's prescribed): Active Comparator	Drug: Subcutaneous Insulin (subject's prescribed) Subcutaneous insulin with dose adjusted according to premeal blood glucose

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.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479258

Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2171083
Study First Received:	May 24, 2007
Results First Received:	October 29, 2008
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00479258 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009