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NCT00138515 · ClinicalTrials.gov registry record · Phase 3
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 418
- Enrollment target
NCT00138515: Completed Phase 3 study, sponsored by Novartis.
NCT00138515 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 418 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00138515, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 418 participants
- Enrollment target
Study Summary
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone. 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 | 418 participants |
| Start Date | 2004-11 |
| Est. Completion | 2006-05 |
| Phase | Phase 3 |
What the finished NCT00138515 record still lists
NCT00138515 is an interventional study that assigns participants to a tested intervention. The registered 418 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 (46% lower).
The record links to 0 conditions, and to 1 intervention - of which vildagliptin is the first listed.
NCT00138515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00138515 about?
NCT00138515 is a clinical study titled "Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes". Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to metformin in people w...
What is the current status of trial NCT00138515?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 418 participants. The study started on 2004-11. Estimated completion is 2006-05.
What interventions are being tested in trial NCT00138515?
The interventions under investigation include: vildagliptin (DRUG).
Who is sponsoring clinical trial NCT00138515?
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 NCT00138515's enrollment target sits among peer trials
418 900th of 2000 higher than 1,099 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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