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NCT00396227 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
2,665
Enrollment target

NCT00396227: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT00396227 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 2,665 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (245% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00396227, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
2,665 participants
Enrollment target

Study Summary

This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.

Interventions

  • DRUG vildagliptin
  • DRUG thiazolidinedione (TZD)

Trial Details

FieldValue
Enrollment Target 2,665 participants
Start Date 2006-10
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00396227 record still lists

NCT00396227 is an interventional study that assigns participants to a tested intervention. Its 2,665 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (245% higher).

The record links to 0 conditions, and to 2 interventions - of which vildagliptin is the first listed.

NCT00396227 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00396227 about?

NCT00396227 is a clinical study titled "Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone". This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.

What is the current status of trial NCT00396227?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,665 participants. The study started on 2006-10.

What interventions are being tested in trial NCT00396227?

The interventions under investigation include: vildagliptin (DRUG), thiazolidinedione (TZD) (DRUG).

Who is sponsoring clinical trial NCT00396227?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00396227's enrollment target sits among peer trials

2,665 84th of 2000 higher than 1,917 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 NCT00396227, the US trial registry maintained by the National Library of Medicine. NCT00396227 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.