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NCT00138554 · ClinicalTrials.gov registry record · Phase 3
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 318
- Enrollment target
NCT00138554 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 318 participants.
The verdict
NCT00138554, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 318 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 pioglitazone in people with type 2 diabetes not at target blood glucose levels on pioglitazone or rosiglitazone 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 pioglitazone
- DRUG vildagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2004-11 |
| Est. Completion | 2006-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00138554
The ClinicalTrials.gov registry entry for NCT00138554 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 318 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 2 interventions - of which pioglitazone is the first listed.
NCT00138554 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00138554 about?
NCT00138554 is a clinical study titled "Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone 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 pioglitazone in peopl...
What is the current status of trial NCT00138554?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 318 participants. The study started on 2004-11. Estimated completion is 2006-07.
What interventions are being tested in trial NCT00138554?
The interventions under investigation include: pioglitazone (DRUG), vildagliptin (DRUG).
Who is sponsoring clinical trial NCT00138554?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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