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NCT00138619 · ClinicalTrials.gov registry record · Phase 3
Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 478
- Enrollment target
NCT00138619: Completed Phase 3 study, sponsored by Novartis.
NCT00138619 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 478 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00138619, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
Study Summary
This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.
Interventions
- DRUG vildagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2004-11 |
| Est. Completion | 2007-04 |
| Phase | Phase 3 |
What the finished NCT00138619 record still lists
NCT00138619 is an interventional study that assigns participants to a tested intervention. The registered 478 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 (38% lower).
The record links to 0 conditions, and to 1 intervention - of which vildagliptin is the first listed.
NCT00138619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00138619 about?
NCT00138619 is a clinical study titled "Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes". This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. The...
What is the current status of trial NCT00138619?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2004-11. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00138619?
The interventions under investigation include: vildagliptin (DRUG).
Who is sponsoring clinical trial NCT00138619?
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 NCT00138619's enrollment target sits among peer trials
478 805th of 2000 higher than 1,194 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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