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NCT00136916 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 635
- Enrollment target
NCT00136916: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT00136916 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 635 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00136916, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 635 participants
- Enrollment target
Study Summary
This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®. 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.
Primary Outcome
Change from Month 3: mean of (value of observed FEV1 \[forced expiratory volume in the first second of forced exhalation\] in liters \[L\] at treatment observation minus Month 3 value).
Interventions
- DRUG Inhaled Insulin
- DRUG Subcutaneous insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 635 participants |
| Start Date | 2002-06 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
Why NCT00136916 stopped before completion
NCT00136916 is an interventional study that assigns participants to a tested intervention. The registered 635 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Inhaled Insulin is the first listed.
NCT00136916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00136916 about?
NCT00136916 is a clinical study titled "Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes". This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®. This study included a 2-year comparative treatment period followed by a 6-...
What is the current status of trial NCT00136916?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 635 participants. The study started on 2002-06. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00136916?
The interventions under investigation include: Inhaled Insulin (DRUG), Subcutaneous insulin (DRUG).
Who is sponsoring clinical trial NCT00136916?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00136916's enrollment target sits among peer trials
635 579th of 2000 higher than 1,422 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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