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NCT00137046 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 582
- Enrollment target
NCT00137046 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 582 participants.
The verdict
NCT00137046, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 582 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Subcutaneous Insulin
- DRUG Inhaled Insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 582 participants |
| Start Date | 2002-05 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00137046
The ClinicalTrials.gov registry entry for NCT00137046 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 582 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Subcutaneous Insulin is the first listed.
NCT00137046 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00137046 about?
NCT00137046 is a clinical study titled "Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes". 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 compara...
What is the current status of trial NCT00137046?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 582 participants. The study started on 2002-05. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00137046?
The interventions under investigation include: Subcutaneous Insulin (DRUG), Inhaled Insulin (DRUG).
Who is sponsoring clinical trial NCT00137046?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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