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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 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 418 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00138515
The ClinicalTrials.gov registry entry for NCT00138515 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 418 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which vildagliptin is the first listed.
NCT00138515 reports 0 study locations.
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.
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