Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
NCT ID: NCT00860288
Last Updated: 2020-12-29
Study Results
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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COMPLETED
PHASE2/PHASE3
1988 participants
INTERVENTIONAL
2009-02-28
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vildagliptin Dose 1
Vildagliptin
Metformin
Vildagliptin Dose 2
Vildagliptin
Metformin
Placebo
Metformin
Placebo
Sitagliptin
Metformin
Sitagliptin
Interventions
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Vildagliptin
Metformin
Placebo
Sitagliptin
Eligibility Criteria
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Inclusion Criteria
* T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1
* Patient agreement to maintain same dose of metformin throughout study
* HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1
* Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1
Exclusion Criteria
* FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)
18 Years
78 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Instituto de Investigaciones Biomedicas
Buenos Aires, Santa Fe Province, Argentina
Grupo Colaborative Rosario
Rosario, Santa Fe Province, Argentina
Grupo Medico Alem
Buenos Aires, , Argentina
DIM Clinical Privada
Buenos Aires, , Argentina
Clinica Medica Sin Internacion
Buenos Aires, , Argentina
Fundación de Estudios Farmacológicos y de Medicamentos
Buenos Aires, , Argentina
Universitaetsklinik Graz medizinische Universitaetsklinik;
Graz, , Austria
LKH Salzburg Landesklinik fuer Innere Medizin I
Salzburg, , Austria
Millergasse 7
Vienna, , Austria
Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment
Vienna, , Austria
Kindlergasse 4
Wiener Neustadt, , Austria
Kindlergasse 4
Wiener Neustadt, , Austria
Private Practice Diabetology (Dr. Coucke)
Sint-Gillis-Waas, Sint-Niklaasstraat 117, Belgium
Private Practice Cardiology (Dr. Hollanders)
De Pinte, , Belgium
Private Practice (Vernijns)
Genk, , Belgium
Private Practice (Dr. De Meulemeester)
Gozée, , Belgium
Huisartsenpraktijk Hygeia
Hasselt, , Belgium
Private Practice (Dr. Jaak Mortelmans)
Oostham, , Belgium
Lihavuustutkimusyksikkö
Helsinki, , Finland
Mehiläinen Töölö Diabetesklinikka
Helsinki, , Finland
Terveystalo Kuopio
Kuopio, , Finland
Mehiläinen Lahti
Lahti, , Finland
ODL Terveys Oy, Tutkimusyksikkö,
Oulu, , Finland
Mehiläinen Riihimäki
Riihimäki, , Finland
Terveystalo Tampereen työterveys Kalmar
Tampere, , Finland
Myyrmäen terveysasema
Vantaa, , Finland
Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger
Augsburg, , Germany
Praxis Dr. Med. Kurt Rack
Augsburg, , Germany
Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht
Bad Kreuznach, , Germany
Klinische Forschung Berlin-Buch
Berlin, , Germany
Praxis Dr. Med. Ulrike Venschott-Jordan
Berlin, , Germany
Praxis Dr. Med. Monika Kiper
Berlin, , Germany
Praxis Dr. Med. Christina Bondke
Berlin, , Germany
Bibertal Klinik
Bibertal, , Germany
Praxis Dr. Med. Claudia Ulbrich
Cologne, , Germany
Gemeinschaftspraxis Dr. med. Ali Boustani
Diez, , Germany
Facharzt fuer Allgemeinmedizin
Dorsten, , Germany
Praxis Dr. Med. Anwar Ansari
Einbeck, , Germany
Hausaerzte am Stern Dr. Med. Blume / Dr. Med. Garanin
Essen, , Germany
Praxis Dr. Med. Roland Kutzke
Essen, , Germany
Praxis Dr. Med. Thorsten Rau
Essen, , Germany
Praxis Dr. Med. Joerg Luedemann / Facharzt fuer Innere Medizin - Diabetologie
Falkensee, , Germany
Praxis Dr. Med. Daniela Freise
Frankfurt, , Germany
Dial.-Med. Kerstin Steinbach
Freital, , Germany
Gemeinschaftspraxis
Fulda, , Germany
Praxis Dr. Med. Wolfgang Krause
Grimma, , Germany
Krankenhaus Hagenow, Innere Medizin
Hagenow, , Germany
MVZ-medicum Hamburg
Hamburg, , Germany
Diabetes-Zentrum Wandsbek
Hamburg, , Germany
Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle
Herne, , Germany
Praxis Dr. Med. Helmut Anderten
Hildesheim, , Germany
Praxis Dr. Med. Juergen Landschulze
Kahla, , Germany
Praxis Dr. Med. Julia Chevts
Karlsruhe, , Germany
Praxis Dr. Med. Hans-Helmut Seibert
Kassel, , Germany
Dres. Klein/Minnich
Künzing, , Germany
Praxis Dr. Med. Birgit Hoene
Leipzig, , Germany
Pro Scientia med
Lübeck, , Germany
Diabetes Schwerpunktpraxis
Meissen, , Germany
Praxis Dres. Prohaska / Lindner
Mühldorf, , Germany
Praxis Dr. Med. Claus-Michael Grimm
München, , Germany
Praxis Dr. Fischer & Dr. Keuthage
Münster, , Germany
Gemeinschaftspraxis Dr. Uwe Böckmann/Dr. med. Maren Molkewehrum
Neumünster, , Germany
Praxis Dr. Med. Joachim Etter
Oberhausen, , Germany
IkFE Studiencenter Potsdam GMBH i.G.
Potsdam, , Germany
Diabetes Center Quakenbrueck
Quakenbrück, , Germany
Praxis Dr. Altwicker, Dr. Kanis
Reinfeld, , Germany
Praxis Dr. Med. Ulrich Aigner
Rothenburg, , Germany
Praxis Dr. Med. Sabine Sedl
Schönberg, , Germany
Dres. Hiltensperger & Schaal
Schrobenhausen, , Germany
Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer
Schwabenheim, , Germany
Praxis Dr. Med. Ottmar Herfert
Stuttgart, , Germany
Praxis Dr. Med. Doru Popa
Veitsbronn, , Germany
Gemeinschaftspraxis Gerhard Steinmaier und Dr. Med. Werner Bauer
Viernheim, , Germany
Gemeinschaftspraxis Sauter
Wangen, , Germany
Praxis Dr. Med. Rudolf Matthias Remppis
Weißenhorn, , Germany
Praxis Dr. Med. Peter Genthner
Welzheim, , Germany
Gemeinschaftspraxis Dr. med. Reinhold Schneider und Christine Schneider
Wetzlar, , Germany
Laiko General Hospital,
Athens, , Greece
Lamia General Hospital
Larissa, , Greece
Papageorgiou General Hospital
Thessaloniki, , Greece
Clínica y Hospital Colón del Paciente Diabético
Guatemala City, , Guatemala
Endonutri S.A
Guatemala City, , Guatemala
Clínica y Hospital Colón del Paciente Diabético
Guatemala City, , Guatemala
Clinica Dr. Erick Turcios
Guatemala City, , Guatemala
Endonutri S. A.
Guatemala City, , Guatemala
Clinica Dr. Sergio Bran
Guatemala City, , Guatemala
Szent Margit Hospita
Budapest, , Hungary
Károlyi Sándor Hospital
Budapest, , Hungary
Szent Imre Hospital
Budapest, , Hungary
Konszenzusplusz Kft.
Csongrád, , Hungary
Petz Aladar Hospital
Győr, , Hungary
Jósa Andras Hospital
Nyíregyháza, , Hungary
Szte-Áok I
Szeged, , Hungary
Balassa Janos Hospital
Szekszárd, , Hungary
Zala Megyei Hospital
Zalaegerszeg, , Hungary
Manipal Hospital,
Bangalore, Karantaka, India
Health and Research Centre
Trivandrum, Kerala, India
Diabetes Thyroid Hormone Research Institute Pvt Ltd.
Indore, Madhya Pradesh, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, India
M. V. Hosp for Diabetes P. Ltd. 4,
Chennai, , India
Medicity Hospital
Hyderabaad, , India
Nizam's institute of medical sciences,
Hyderabaad, , India
S. R. Kalla Memorial gastro and general hosp,
Jaipur, , India
Christian Medical College,
Vellore, , India
Maccabi Healthcare Services
Rishon LeZiyyon, , Israel
Ziv Medical Center
Safed, , Israel
U.O.C. di Diabetologia e Malattie Metaboliche
Arenzano, , Italy
U.S.C. di Endocrinologia (Ingresso 13 - piano 2) Dip. di Medicina
Bergamo, , Italy
U.O.C. Diabetologia Endocrinologia Dip. Medico
Campobasso, , Italy
U.O. Medicina Generale
Casorate Primo, , Italy
I Divisione Medicina
Catania, , Italy
U.O. Malattie Metaboliche e Diabetologia
Chieri, , Italy
U.O.C. di Medicina d'Urgenza e Pronto Soccorso
Cosenza, , Italy
Servizio Diabetologia, SOD Cardiologia Geriatrica - D.A.I. del Cuore e dei Vasi
Florence, , Italy
Centro Diabetologico Malattie Metaboliche
Mercato San Severino, , Italy
Divisione Malattie Metaboliche e Diabetologia
Milan, , Italy
S. Semplice Dip. di Endocrinologia e Diabetologia Dip. di Medicina Interna
Milan, , Italy
U.O. Medicina II - Dip. Medicina Interna
Milan, , Italy
Unità Cardio-Metabolica e Trials Clinici Dipartimento di Medicina Interna
Milan, , Italy
U.O. Diabetologia
Olbia, , Italy
Centro per l'Aterosclerosi Dip. di Medicina Interna
Roma, , Italy
U.O. Endocrinologia e Diabetologia
Roma, , Italy
U.O.C. di Diabetologia c/o AUSL ROMA B - Sede Territoriale
Roma, , Italy
U.O.C. di Medicina Interna B - BMI02 Dip. Scienze Cliniche - II Clinica Medica
Roma, , Italy
S. S. di Diabetologia Dip. Med. Interna e Malattie Metaboliche
Siena, , Italy
S.C. Prevenzione-Riabilitazione Cardiologica presso ex-Dispensario
Vibo Valentia, , Italy
Daugavpils Regional Hospital
Daugavpils, , Latvia
Primary Health Centre of Jaunliepaja
Liepāja, , Latvia
Private practice of endocrinology
Ogre, , Latvia
Center of Endocrinology
Riga, , Latvia
Riga Outpatient Clinic "Dziednieciba"
Riga, , Latvia
Talsi Clinical Hospital
Talsi, , Latvia
Endocrinology Department of Vidzemes Hospital
Valmiera, , Latvia
JSC "Klinikiniai sprendimai"
Alytus, , Lithuania
Kaunas District Hospital
Kaunas, , Lithuania
Kaunas Silainiai Outpatient Clinic
Kaunas, , Lithuania
Kaunas Medical University Hospital
Kaunas, , Lithuania
Kaunas Dainavos Outpatient Clinic
Kaunas, , Lithuania
Vilnius University Hospital Santariskiu Clinics
Vilnius, , Lithuania
Private Endocrinology Clinic
Vilnius, , Lithuania
Comité Bioetico para la Investigación Clínica S.C.
Mexico City, Durango, Mexico
Unidad Metabolica y Cardiovascular S.C.
Cuernavaca, Morelos, Mexico
Clínica Eugenio Sue
Mexico City, Polanco Chapultepec, Mexico
Clínica de Diabetes de la Secretaria de Salud de Durango
Durango, , Mexico
Arke Estudios Clinicos S.A. de C.V.
Mexico City, , Mexico
Flattum legesenter
Hønefoss, , Norway
Randesund Helsesenter
Kristiansand, , Norway
Sinsenklinikken
Oslo, , Norway
Oslo Universitetssykehus
Oslo, , Norway
Hinnastrekanten legekontor
Stavanger, , Norway
Vennesla legesenter
Vennesla, , Norway
Clinica San Miguel
Arequipa, , Peru
Clinica Geriatrica Militar
Lima, , Peru
Clinica San Borja
Lima, , Peru
Clinica Senor de los Milagros
Lima, , Peru
Hospital Nacional Cayetano Heredia
Lima, , Peru
Hospital Nacional Guillermo Almenara Irigoyen
Lima, , Peru
Bydgoskie Centrum Diabetologii i Endokrynologii
Bydgoszcz, , Poland
NZOZ "Specjalista" Sp z o. o.
Kutno, , Poland
Oddzial Chorob Wewnetrznych
Mielec, , Poland
Poradnia Lekarza Rodzinnego
Poznan, , Poland
Poznański Ośrodek Medyczny "NOVAMED"
Poznan, , Poland
CMI Cardiologie "Dr. Pop Calin Florin"
Baia Mare, , Romania
"C. I. Parhon" Endocrinology Institute
Bucharest, , Romania
Medical Centre "Sanatatea Ta" SRL
Bucharest, , Romania
Medical Practice SRL
Oradea, , Romania
Anamed SRL
Oradea, , Romania
Emergency County Hospital Ploiesti
Ploieşti, , Romania
Policlinica "Dr. Citu"
Timișoara, , Romania
MEDISPEKTRUM s.r.o,
Bratislava, Slovak Republic, Slovakia
.Interna klinika, FN J.A. Reimana
Prešov, Slovak Republic, Slovakia
Diabetologicka ambulancia,
Bratislava, Slovakia Republic, Slovakia
Diabetologicka ambulancia
Košice, Slovakia Republic, Slovakia
Diabetologicka ambulancia,
Lučenec, Slovakia Republic, Slovakia
NZZ Diabetologicka ambulancia
Nové Zámky, Slovakia Republic, Slovakia
Diabetes centrum s.r.o
Trenčín, Slovakia Republic, Slovakia
Diabetologicka ambulancia,
Žilina, Slovakia Republic, Slovakia
Diametabol.s.r.o.,
Bratislava, , Slovakia
MUDr. Margita Kiripolska s.r.o
Považská Bystrica, , Slovakia
Eulji General Hospital
Seoul, , South Korea
Kangbuk Samsung Medical center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
The Catholic University of Korea Holy Family Hospital
Seoul, , South Korea
Ajou university hospital
Suwon, , South Korea
Ambulatorio Militar Tipo III Paramacay. Avenida Universidad. Sector Santa Ana. Naguanagua.
Valencia, Carabobo, Venezuela
Hospital Militar Dr Carlos Arvelo. Final Av. José Angel Lamas. Servicio de Endocrinología.
Caracas, , Venezuela
Hospital Dr Miguel Perez Carreño. Servicio de Endocrinología. Sotano.
Caracas, , Venezuela
Countries
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Related Links
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Results for CLAF237B2224 from the Novartis Clinical Trials website
Other Identifiers
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CLAF237B2224
Identifier Type: -
Identifier Source: org_study_id