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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.

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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

FieldValue
Enrollment Target 478 participants
Start Date 2004-11
Est. Completion 2007-04
Phase Phase 3

Sponsor

Novartis

265 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.