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

Diabetes Mellitus, Type 1 Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00479258
• Other study ID #: A2171083
• Status: Terminated
• Phase: Phase 3
• Start date: October 2007
• Est. completion date: October 2007

Study information

• Verified date: August 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Inhaled insulin (Exubera)
Inhaled insulin with dose adjusted according to premeal blood glucose
• Subcutaneous Insulin (subject's prescribed)
Subcutaneous insulin with dose adjusted according to premeal blood glucose

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period	No subjects were dosed therefore no data collected.	12 months
Secondary	Change From Baseline in Other PFT Parameters		12 months
Secondary	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
Secondary	Treatment Preferences.		12 months
Secondary	Change From Baseline in FVC		12 months
Secondary	Slope for Other PFT Parameters;		12 months
Secondary	Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c		12 months
Secondary	Change From Baseline in Insulin Antibodies (microU/mL);		12 months
Secondary	Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;		12 months
Secondary	Hypoglycemic Event Rates;		12 months
Secondary	7 Point Home Glucose		12 months

External Links

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