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NCT00138541 · ClinicalTrials.gov registry record · Phase 3
Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 440
- Enrollment target
NCT00138541: Completed Phase 3 study, sponsored by Novartis.
NCT00138541 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 440 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00138541, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 440 participants
- Enrollment target
Study Summary
This is a 28-week extension to a study of the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather long-term safety and efficacy data for vildagliptin in people with type 2 diabetes.
Interventions
- DRUG vildagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2004-10 |
| Est. Completion | 2006-04 |
| Phase | Phase 3 |
What the finished NCT00138541 record still lists
NCT00138541 is an interventional study that assigns participants to a tested intervention. The registered 440 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 (43% lower).
The record links to 0 conditions, and to 1 intervention - of which vildagliptin is the first listed.
NCT00138541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00138541 about?
NCT00138541 is a clinical study titled "Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes". This is a 28-week extension to a study of the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. Th...
What is the current status of trial NCT00138541?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2004-10. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00138541?
The interventions under investigation include: vildagliptin (DRUG).
Who is sponsoring clinical trial NCT00138541?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00138541's enrollment target sits among peer trials
440 867th of 2000 higher than 1,129 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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