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

NCT00479258 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-10-01

Study results available
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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

Interventions

DRUG

Inhaled insulin (Exubera)

Inhaled insulin with dose adjusted according to premeal blood glucose

DRUG

Subcutaneous Insulin (subject's prescribed)

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00479258 on ClinicalTrials.gov