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NCT00396357 · ClinicalTrials.gov registry record · Phase 3

Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
914
Enrollment target

NCT00396357: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT00396357 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 914 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00396357, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
914 participants
Enrollment target

Study Summary

This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

Interventions

  • DRUG metformin
  • DRUG Vildagliptin

Trial Details

FieldValue
Enrollment Target 914 participants
Start Date 2006-10
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00396357 record still lists

NCT00396357 is an interventional study that assigns participants to a tested intervention. The registered 914 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher).

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

NCT00396357 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00396357 about?

NCT00396357 is a clinical study titled "Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone". This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

What is the current status of trial NCT00396357?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 914 participants. The study started on 2006-10.

What interventions are being tested in trial NCT00396357?

The interventions under investigation include: metformin (DRUG), Vildagliptin (DRUG).

Who is sponsoring clinical trial NCT00396357?

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 NCT00396357's enrollment target sits among peer trials

914 347th of 2000 higher than 1,654 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 NCT00396357, the US trial registry maintained by the National Library of Medicine. NCT00396357 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.