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%)

NCT ID: NCT00728351

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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Type 2 diabetes, vildagliptin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vildagliptin + metformin

Group Type EXPERIMENTAL

vildagliptin + metformin

Intervention Type DRUG

metformin

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

1000 bid metformin

Interventions

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vildagliptin + metformin

Intervention Type DRUG

metformin

1000 bid metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of T2DM treated with Metformin

Exclusion Criteria

* FPG \>= 260 mg/dL (14.4mmol/L)
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Pine Bluff, Arkansas, United States

Site Status

Long Beach, California, United States

Site Status

Denver, Colorado, United States

Site Status

Bangor, Maine, United States

Site Status

Billings, Montana, United States

Site Status

Novartis Investigative Site

New Brunswick, New Jersey, United States

Site Status

Trenton, New Jersey, United States

Site Status

Wilmington, North Carolina, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Uniontown, Pennsylvania, United States

Site Status

Taylors, South Carolina, United States

Site Status

Houston, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Norfolk, Virginia, United States

Site Status

Wenatchee, Washington, United States

Site Status

Cabinet d'Endocrinologie-Maladies Métaboliques

Annecy, , France

Site Status

Service Endocrinologic & Metabolisme

Paris, , France

Site Status

Polycliniques des minguettes

Vénissieux, , France

Site Status

Hausärztliche Praxis

Aschaffenburg, , Germany

Site Status

Klinische Forschung Berlin Mitte GmbH

Berlin, , Germany

Site Status

AVK

Berlin, , Germany

Site Status

Gemeinschaftspraxis

Celle, , Germany

Site Status

Malteser KM

Duisburg, , Germany

Site Status

Untertrintroper Hausarztzentrum

Essen, , Germany

Site Status

Gefrees, , Germany

Site Status

Diabeteszentrum Billstedt/Horn

Hamburg, , Germany

Site Status

Diabetologische Schwerpunktpraxis

Hamburg, , Germany

Site Status

St. Elisabeth Krankenhaus Leipzig

Leipzig, , Germany

Site Status

Diabetes-Schwerpunktpraxis Studienambulanz

Leipzig, , Germany

Site Status

Institut für Diabetes-forschung Münster

Münster, , Germany

Site Status

Praxis Dr. Alawi

Saarlouis, , Germany

Site Status

DDT

Siegen, , Germany

Site Status

Diabetologische Schwerpunktpraxis

Sinsheim, , Germany

Site Status

Praxis

Wangen, , Germany

Site Status

Europ-Med Orvosi Szolgaltato Kft

Budaörs, , Hungary

Site Status

Synexus Magyarorszag

Budapest, , Hungary

Site Status

Uzsoki Hospital

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Kenezy Hospital

Debrecen, , Hungary

Site Status

Gyngyosi Korhaz Kft

Gyöngyös, , Hungary

Site Status

Petz Aladar County

Győr, , Hungary

Site Status

Selye Janos Korhaz es Rendelointezet

Komárom, , Hungary

Site Status

DIAPED Kft., MRC

Meggyesalja U., , Hungary

Site Status

Josa Andras Teaching Hospital

Nyíregyháza, , Hungary

Site Status

Vas Megyei Markuscvszky Lajos Korhaz

Szombathely, , Hungary

Site Status

Zala County Hospital

Zalaegerszeg, , Hungary

Site Status

NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok

Bialystok, , Poland

Site Status

Gdanska Poradnia Cukrzycowa

Gdansk, , Poland

Site Status

Gabinet Kardiologiczny Mediplus

Gdynia, , Poland

Site Status

NZOZ "Esculap" S.C.

Gniewkowo, , Poland

Site Status

SZPZOZ Szpital Zachodni im. Jana Pawla II

Grodzisk Mazowiecki, , Poland

Site Status

NZOZ Terapia Optima

Katowice, , Poland

Site Status

Instytut Cantrum Zdrowia Matki Polki

Lodz, , Poland

Site Status

NZOZ Special-Med

Lublin, , Poland

Site Status

Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza

Poznan, , Poland

Site Status

Lecznica Prosen-SMO NZOZ

Warsaw, , Poland

Site Status

Centrum Leczenia Chorob Cywilizacyjnych

Warsaw, , Poland

Site Status

NZCZ Regionalna Poradnia Diabetologiczna

Wroclaw, , Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny Nr 1

Wroclaw, , Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM

Zabrze, , Poland

Site Status

Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy

Łęczyca, , Poland

Site Status

Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca

Łęczyca, , Poland

Site Status

Countries

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United States France Germany Hungary Poland

Related Links

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http://www.novartisclinicaltrials.com

Click here for more information on the clinical study

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3860

Results for CLMF237A2309 from the Novartis Clinical Trials website

Other Identifiers

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CLMF237A2309

Identifier Type: -

Identifier Source: org_study_id