Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
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.
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
- Enrollment
- 582 participants
Conditions and interventions
Conditions
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
- May 2002 (Type not available)
- Primary completion
- Dec 2008 (Actual)
- Completion
- Dec 2008 (Actual)
- Last update posted
- Feb 18, 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 18, 2010 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00137046 live on ClinicalTrials.gov.