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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00396357

Public ClinicalTrials.gov record NCT00396357. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 7, 2026, 10:00 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00396357
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
914 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 78 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2006 (Type not available)
Primary completion
Jun 2008 (Actual)
Completion
Not listed
Last update posted
Dec 17, 2020

Started 2006

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Novartis Pharmaceuticals East Hanover New Jersey 07936 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00396357, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 17, 2020 · Synced Nov 7, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00396357 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →