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

NCT00479258 | Terminated Phase 3 Results

• 1 other identifier: A2171083
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change From Baseline in Other PFT Parameters

  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;

  12 months

• Treatment Preferences.

  12 months

• Change From Baseline in FVC

  12 months

• Slope for Other PFT Parameters;

  12 months

Study Arms (2)

Inhaled insulin (Exubera)

EXPERIMENTAL

Drug: Inhaled insulin (Exubera)

Subcutaneous Insulin (subject's prescribed)

ACTIVE COMPARATOR

Drug: Subcutaneous Insulin (subject's prescribed)

Interventions

Inhaled insulin (Exubera) DRUG

Inhaled insulin with dose adjusted according to premeal blood glucose

Inhaled insulin (Exubera)

Subcutaneous Insulin (subject's prescribed) DRUG

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Subcutaneous Insulin (subject's prescribed)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Subjects using an insulin pump
• Smoking

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Buffalo, New York, 14222, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Exubera

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Pfizer announced Oct07 it would stop marketing Exubera; recruitment placed on hold. Nektar, from which Pfizer licensed Exubera, announced April 9, 2008 it had stopped its search for a new marketing partner. Study terminated; no further recruitment.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 28, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 1, 2018
• Results First Posted: November 3, 2008

Record last verified: 2018-08

Locations

US (1)