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Completed Phase 3 Interventional

Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes

ClinicalTrials.gov ID: NCT00424411

Public ClinicalTrials.gov record NCT00424411. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 3:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To determine, in subjects with Type 2 Diabetes Mellitus: 1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day. 2. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.

Study identification

NCT ID
NCT00424411
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pfizer
Industry
Enrollment
300 participants

Conditions and interventions

Eligibility (public fields only)

Age range
35 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 1999
Primary completion
Not listed
Completion
Nov 30, 2000
Last update posted
Feb 12, 2007

1999 – 2000

United States locations

U.S. sites
34
U.S. states
17
U.S. cities
34
Facility City State ZIP Site status
Pfizer Investigational Site Burlingame California
Pfizer Investigational Site Irvine California
Pfizer Investigational Site Los Angeles California
Pfizer Investigational Site Newport Beach California
Pfizer Investigational Site Orange California
Pfizer Investigational Site San Diego California
Pfizer Investigational Site San Francisco California
Pfizer Investigational Site Tustin California
Pfizer Investigational Site New Haven Connecticut
Pfizer Investigational Site Washington D.C. District of Columbia
Pfizer Investigational Site Clearwater Florida
Pfizer Investigational Site Miami Florida
Pfizer Investigational Site Tampa Florida
Pfizer Investigational Site Chicago Illinois
Pfizer Investigational Site Louisville Kentucky
Pfizer Investigational Site New Orleans Louisiana
Pfizer Investigational Site Columbia Missouri
Pfizer Investigational Site St Louis Missouri
Pfizer Investigational Site Omaha Nebraska
Pfizer Investigational Site New Hyde Park New York
Pfizer Investigational Site New York New York
Pfizer Investigational Site Rochester New York
Pfizer Investigational Site Durham North Carolina
Pfizer Investigational Site Greenville North Carolina
Pfizer Investigational Site Winston-Salem North Carolina
Pfizer Investigational Site Cleveland Ohio
Pfizer Investigational Site Portland Oregon
Pfizer Investigational Site Austin Texas
Pfizer Investigational Site Dallas Texas
Pfizer Investigational Site Irving Texas
Pfizer Investigational Site San Antonio Texas
Pfizer Investigational Site Burlington Vermont
Pfizer Investigational Site Charlottesville Virginia
Pfizer Investigational Site Renton Washington

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00424411, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 12, 2007 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00424411 live on ClinicalTrials.gov.

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