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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 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 478 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00138619
The ClinicalTrials.gov registry entry for NCT00138619 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 478 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.
NCT00138619 reports 0 study locations.
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.
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