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Terminated Phase 3 Interventional Results available

Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes

ClinicalTrials.gov ID: NCT00137046

Public ClinicalTrials.gov record NCT00137046. 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 Exubera (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 1 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial

Brief summary

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

This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin). This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.

Study identification

NCT ID
NCT00137046
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pfizer
Industry
Enrollment
582 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 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
Apr 30, 2002
Primary completion
Nov 30, 2008
Completion
Nov 30, 2008
Last update posted
Feb 17, 2010

2002 – 2008

United States locations

U.S. sites
36
U.S. states
18
U.S. cities
34
Facility City State ZIP Site status
Pfizer Investigational Site Fullerton California 92835
Pfizer Investigational Site Long Beach California 90806
Pfizer Investigational Site Sacramento California 95816
Pfizer Investigational Site San Diego California 92103
Pfizer Investigational Site Santa Barbara California 93105
Pfizer Investigational Site Santa Rosa California 95405
Pfizer Investigational Site Tustin California 92780
Pfizer Investigational Site Walnut Creek California 94598
Pfizer Investigational Site Denver Colorado 80220
Pfizer Investigational Site Longmont Colorado 80501
Pfizer Investigational Site Hamden Connecticut 06518
Pfizer Investigational Site Madison Connecticut 06443
Pfizer Investigational Site Newark Delaware 19713
Pfizer Investigational Site Coral Gables Florida 33134
Pfizer Investigational Site Hollywood Florida 33021
Pfizer Investigational Site Miami Florida 33136
Pfizer Investigational Site Tallahassee Florida 32308
Pfizer Investigational Site West Palm Beach Florida 33401
Pfizer Investigational Site Winter Park Florida 32789
Pfizer Investigational Site Chicago Illinois 60602
Pfizer Investigational Site Chicago Illinois 60610
Pfizer Investigational Site Wilmette Illinois 60091
Pfizer Investigational Site Bethesda Maryland 20817
Pfizer Investigational Site St Louis Missouri 63141
Pfizer Investigational Site Butte Montana 59701
Pfizer Investigational Site New Hyde Park New York 11042
Pfizer Investigational Site Durham North Carolina 27713
Pfizer Investigational Site Portland Oregon 97210
Pfizer Investigational Site Lansdale Pennsylvania 19446
Pfizer Investigational Site Dallas Texas 75230
Pfizer Investigational Site Dallas Texas 75246
Pfizer Investigational Site San Antonio Texas 78229
Pfizer Investigational Site Burlington Vermont 05401
Pfizer Investigational Site Richmond Virginia 23225
Pfizer Investigational Site Renton Washington 98057
Pfizer Investigational Site Milwaukee Wisconsin 53209

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 37 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00137046, 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 17, 2010 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00137046 live on ClinicalTrials.gov.

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