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NCT00138567 · ClinicalTrials.gov registry record · Phase 3

Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

A Phase 3 study, sponsored by Novartis.

Completed
Registry status
Phase 3
Development phase
530
Enrollment target

NCT00138567: Completed Phase 3 study, sponsored by Novartis.

NCT00138567 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 530 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00138567, a Phase 3 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 3
Development phase
530 participants
Enrollment target

Study Summary

This is a 52-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously 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 530 participants
Start Date 2005-01
Est. Completion 2006-08
Phase Phase 3
Novartis

265 total trials

What the finished NCT00138567 record still lists

NCT00138567 is an interventional study that assigns participants to a tested intervention. The registered 530 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 (31% lower).

The record links to 0 conditions, and to 1 intervention - of which vildagliptin is the first listed.

NCT00138567 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00138567 about?

NCT00138567 is a clinical study titled "Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes". This is a 52-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purp...

What is the current status of trial NCT00138567?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2005-01. Estimated completion is 2006-08.

What interventions are being tested in trial NCT00138567?

The interventions under investigation include: vildagliptin (DRUG).

Who is sponsoring clinical trial NCT00138567?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00138567's enrollment target sits among peer trials

530 706th of 2000 higher than 1,292 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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Source: ClinicalTrials.gov NCT00138567, the US trial registry maintained by the National Library of Medicine. NCT00138567 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.