Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

ClinicalTrials.gov ID: NCT00728351

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Official title

A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.

Brief summary

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

The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

Study identification

NCT ID: NCT00728351
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 317 participants

Conditions and interventions

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptin + metformin Drug
metformin Drug

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: Jun 2008 (Type not available)
Primary completion: Feb 2010 (Actual)
Completion: Not listed
Last update posted: Dec 19, 2020

Started 2008

United States locations

U.S. sites: 16
U.S. states: 13
U.S. cities: 14

Facility	City	State	ZIP	Site status
Not listed	Pine Bluff	Arkansas	71603	—
Not listed	Long Beach	California	90806	—
Not listed	Denver	Colorado	80209	—
Not listed	Bangor	Maine	04401	—
Not listed	Billings	Montana	59102	—
Novartis Investigative Site	New Brunswick	New Jersey	08903	—
Not listed	Trenton	New Jersey	08611	—
Not listed	Wilmington	North Carolina	28409	—
Not listed	Oklahoma City	Oklahoma	73104	—
Not listed	Uniontown	Pennsylvania	—	—
Not listed	Taylors	South Carolina	29687	—
Not listed	Houston	Texas	77023	—
Not listed	Houston	Texas	77074	—
Not listed	Houston	Texas	77081	—
Not listed	Norfolk	Virginia	23510	—
Not listed	Wenatchee	Washington	98801	—

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 47 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00728351, 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 19, 2020 · Synced Nov 15, 2026