Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Last updated: December 17, 2020
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

2/3

Condition

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT00860288
CLAF237B2224
  • Ages 18-78
  • All Genders

Study Summary

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18-78 years old inclusive at Visit 1
  • T2DM patients treated with metformin for at least 3 months and a stable dose of atleast 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

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)

Study Design

Total Participants: 1988
Study Start date:
February 01, 2009
Estimated Completion Date:
March 31, 2011

Connect with a study center

  • Instituto de Investigaciones Biomedicas

    Buenos Aires, Santa Fe 3000FNF
    Argentina

    Site Not Available

  • Grupo Colaborative Rosario

    Rosario, Santa Fe S2002OJP
    Argentina

    Site Not Available

  • Clinica Medica Sin Internacion

    Buenos Aires, B1824KAJ
    Argentina

    Site Not Available

  • DIM Clinical Privada

    Buenos Aires, B1704ETD
    Argentina

    Site Not Available

  • Grupo Medico Alem

    Buenos Aires, B1642DCD
    Argentina

    Site Not Available

  • Fundación de Estudios Farmacológicos y de Medicamentos

    Buenos Aires,, C1027AAP
    Argentina

    Site Not Available

  • Universitaetsklinik Graz medizinische Universitaetsklinik;

    Graz, 8036
    Austria

    Site Not Available

  • LKH Salzburg Landesklinik fuer Innere Medizin I

    Salzburg, 5020
    Austria

    Site Not Available

  • Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment

    Wien, 1140
    Austria

    Site Not Available

  • Millergasse 7

    Wien, 1060
    Austria

    Site Not Available

  • Kindlergasse 4

    Wiener Neustadt, 2700
    Austria

    Site Not Available

  • Private Practice Diabetology (Dr. Coucke)

    Sint-Gillis-Waas, Sint-Niklaasstraat 117 9170
    Belgium

    Site Not Available

  • Private Practice Cardiology (Dr. Hollanders)

    De Pinte, 9840
    Belgium

    Site Not Available

  • Private Practice (Vernijns)

    Genk, 3600
    Belgium

    Site Not Available

  • Private Practice (Dr. De Meulemeester)

    Gozee, 6534
    Belgium

    Site Not Available

  • Huisartsenpraktijk Hygeia

    Hasselt, 3500
    Belgium

    Site Not Available

  • Private Practice (Dr. Jaak Mortelmans)

    Oostham, 3945
    Belgium

    Site Not Available

  • Lihavuustutkimusyksikkö

    Helsinki, 2 A 2 00270
    Finland

    Site Not Available

  • Mehiläinen Töölö Diabetesklinikka

    Helsinki, 47 A 00260
    Finland

    Site Not Available

  • Terveystalo Kuopio

    Kuopio, 70100
    Finland

    Site Not Available

  • Mehiläinen Lahti

    Lahti, 6 C 15110
    Finland

    Site Not Available

  • ODL Terveys Oy, Tutkimusyksikkö,

    Oulu, 90100
    Finland

    Site Not Available

  • Mehiläinen Riihimäki

    Riihimäki, 11130
    Finland

    Site Not Available

  • Mehiläinen Riihimäki

    Riihimäki, 11130
    Finland

    Site Not Available

  • Terveystalo Tampereen työterveys Kalmar

    Tampere, 33900
    Finland

    Site Not Available

  • Myyrmäen terveysasema

    Vantaa, 01600
    Finland

    Site Not Available

  • Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger

    Augsburg, 86150
    Germany

    Site Not Available

  • Praxis Dr. Med. Kurt Rack

    Augsburg, 86150
    Germany

    Site Not Available

  • Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht

    Bad Kreuznach, 55545
    Germany

    Site Not Available

  • Klinische Forschung Berlin-Buch

    Berlin, 10117
    Germany

    Site Not Available

  • Praxis Dr. Med. Christina Bondke

    Berlin, 13189
    Germany

    Site Not Available

  • Praxis Dr. Med. Monika Kiper

    Berlin, 12347
    Germany

    Site Not Available

  • Praxis Dr. Med. Ulrike Venschott-Jordan

    Berlin, 12247
    Germany

    Site Not Available

  • Bibertal Klinik

    Bibertal, 89346
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. med. Ali Boustani

    Diez, 65582
    Germany

    Site Not Available

  • Facharzt fuer Allgemeinmedizin

    Dorsten, 46282
    Germany

    Site Not Available

  • Praxis Dr. Med. Anwar Ansari

    Einbeck, 37574
    Germany

    Site Not Available

  • Hausaerzte am Stern Dr. Med. Blume / Dr. Med. Garanin

    Essen, 45130
    Germany

    Site Not Available

  • Praxis Dr. Med. Roland Kutzke

    Essen, 45144
    Germany

    Site Not Available

  • Praxis Dr. Med. Thorsten Rau

    Essen, 45276
    Germany

    Site Not Available

  • Praxis Dr. Med. Joerg Luedemann / Facharzt fuer Innere Medizin - Diabetologie

    Falkensee, 14612
    Germany

    Site Not Available

  • Praxis Dr. Med. Daniela Freise

    Frankfurt, 60599
    Germany

    Site Not Available

  • Dial.-Med. Kerstin Steinbach

    Freital, 01705
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Fulda, 36037
    Germany

    Site Not Available

  • Praxis Dr. Med. Wolfgang Krause

    Grimma, 04668
    Germany

    Site Not Available

  • Krankenhaus Hagenow, Innere Medizin

    Hagenow, 19230
    Germany

    Site Not Available

  • Diabetes-Zentrum Wandsbek

    Hamburg, 22041
    Germany

    Site Not Available

  • MVZ-medicum Hamburg

    Hamburg, 20097
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle

    Herne, 44653
    Germany

    Site Not Available

  • Praxis Dr. Med. Helmut Anderten

    Hildesheim, 31139
    Germany

    Site Not Available

  • Praxis Dr. Med. Juergen Landschulze

    Kahla, 07768
    Germany

    Site Not Available

  • Praxis Dr. Med. Julia Chevts

    Karlsruhe, 76199
    Germany

    Site Not Available

  • Praxis Dr. Med. Hans-Helmut Seibert

    Kassel, 34125
    Germany

    Site Not Available

  • Praxis Dr. Med. Claudia Ulbrich

    Koeln, 50823
    Germany

    Site Not Available

  • Dres. Klein/Minnich

    Kuenzing, 94550
    Germany

    Site Not Available

  • Praxis Dr. Med. Birgit Hoene

    Leipzig,
    Germany

    Site Not Available

  • Pro Scientia med

    Luebeck, 23562
    Germany

    Site Not Available

  • Diabetes Schwerpunktpraxis

    Meissen, 01662
    Germany

    Site Not Available

  • Praxis Dres. Prohaska / Lindner

    Muehldorf, 84453
    Germany

    Site Not Available

  • Praxis Dr. Med. Claus-Michael Grimm

    Muenchen, 81373
    Germany

    Site Not Available

  • Praxis Dr. Fischer & Dr. Keuthage

    Muenster, 48153
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. Uwe Böckmann/Dr. med. Maren Molkewehrum

    Neumunster, 24534
    Germany

    Site Not Available

  • Praxis Dr. Med. Joachim Etter

    Oberhausen, 46049
    Germany

    Site Not Available

  • IkFE Studiencenter Potsdam GMBH i.G.

    Potsdam, 14469
    Germany

    Site Not Available

  • Diabetes Center Quakenbrueck

    Quakenbrueck, 49610
    Germany

    Site Not Available

  • Praxis Dr. Altwicker, Dr. Kanis

    Reinfeld, 23858
    Germany

    Site Not Available

  • Praxis Dr. Med. Ulrich Aigner

    Rothenburg,
    Germany

    Site Not Available

  • Praxis Dr. Med. Sabine Sedl

    Schoenberg, 23923
    Germany

    Site Not Available

  • Dres. Hiltensperger & Schaal

    Schrobenhausen, 86529
    Germany

    Site Not Available

  • Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer

    Schwabenheim, 55270
    Germany

    Site Not Available

  • Praxis Dr. Med. Ottmar Herfert

    Stuttgart, 70469
    Germany

    Site Not Available

  • Praxis Dr. Med. Doru Popa

    Veitsbronn, 90587
    Germany

    Site Not Available

  • Gemeinschaftspraxis Gerhard Steinmaier und Dr. Med. Werner Bauer

    Viernheim, 68519
    Germany

    Site Not Available

  • Gemeinschaftspraxis Sauter

    Wangen, 88239
    Germany

    Site Not Available

  • Praxis Dr. Med. Rudolf Matthias Remppis

    Weissenhorn, 89264
    Germany

    Site Not Available

  • Praxis Dr. Med. Peter Genthner

    Welzheim, 73642
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. med. Reinhold Schneider und Christine Schneider

    Wetzlar, 35584
    Germany

    Site Not Available

  • Laiko General Hospital,

    Athens, GR11527
    Greece

    Site Not Available

  • Lamia General Hospital

    Larisa, GR 35100
    Greece

    Site Not Available

  • Papageorgiou General Hospital

    Thessaloniki, GR56403
    Greece

    Site Not Available

  • Clinica Dr. Erick Turcios

    Guatemala City, Oficina 1114
    Guatemala

    Site Not Available

  • Clinica Dr. Sergio Bran

    Guatemala City,
    Guatemala

    Site Not Available

  • Clínica y Hospital Colón del Paciente Diabético

    Guatemala City, 01001
    Guatemala

    Site Not Available

  • Endonutri S. A.

    Guatemala City, Oficina 909
    Guatemala

    Site Not Available

  • Endonutri S.A

    Guatemala City, 01010
    Guatemala

    Site Not Available

  • Károlyi Sándor Hospital

    Budapest, 1041
    Hungary

    Site Not Available

  • Szent Imre Hospital

    Budapest, 1115
    Hungary

    Site Not Available

  • Szent Margit Hospita

    Budapest, 1032
    Hungary

    Site Not Available

  • Konszenzusplusz Kft.

    Csongrád, 6640
    Hungary

    Site Not Available

  • Konszenzusplusz Kft.

    Csongrád, 6640
    Hungary

    Site Not Available

  • Petz Aladar Hospital

    Győr, 9023
    Hungary

    Site Not Available

  • Petz Aladar Hospital

    Győr, 9023
    Hungary

    Site Not Available

  • Jósa Andras Hospital

    Nyíregyháza,
    Hungary

    Site Not Available

  • Jósa Andras Hospital

    Nyíregyháza,
    Hungary

    Site Not Available

  • Szte-Áok I

    Szeged, 6720
    Hungary

    Site Not Available

  • Balassa Janos Hospital

    Szekszárd, 7100
    Hungary

    Site Not Available

  • Balassa Janos Hospital

    Szekszárd, 7100
    Hungary

    Site Not Available

  • Zala Megyei Hospital

    Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • Manipal Hospital,

    Bangalore, Karantaka 560 017
    India

    Site Not Available

  • Health and Research Centre

    Trivandrum, Kerela 695 001
    India

    Site Not Available

  • Diabetes Thyroid Hormone Research Institute Pvt Ltd.

    Indore, Madhya Pradesh 452001
    India

    Site Not Available

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu 500 082
    India

    Site Not Available

  • M. V. Hosp for Diabetes P. Ltd. 4,

    Chennai, 13
    India

    Site Not Available

  • Medicity Hospital

    Hyderabaad, 500 036
    India

    Site Not Available

  • Nizam's institute of medical sciences,

    Hyderabaad, 500 082
    India

    Site Not Available

  • S. R. Kalla Memorial gastro and general hosp,

    Jaipur, 302001
    India

    Site Not Available

  • Christian Medical College,

    Vellore, P. O. Box. No. 3.
    India

    Site Not Available

  • Maccabi Healthcare Services

    Rishon Le Zion, 75650
    Israel

    Site Not Available

  • Ziv Medical Center

    Safed, 13100
    Israel

    Site Not Available

  • U.O.C. di Diabetologia e Malattie Metaboliche

    Arenzano,
    Italy

    Site Not Available

  • U.S.C. di Endocrinologia (Ingresso 13 - piano 2) Dip. di Medicina

    Bergamo,
    Italy

    Site Not Available

  • U.O.C. Diabetologia Endocrinologia Dip. Medico

    Campobasso,
    Italy

    Site Not Available

  • U.O. Medicina Generale

    Casorate Primo,
    Italy

    Site Not Available

  • I Divisione Medicina

    Catania,
    Italy

    Site Not Available

  • U.O. Malattie Metaboliche e Diabetologia

    Chieri,
    Italy

    Site Not Available

  • U.O.C. di Medicina d'Urgenza e Pronto Soccorso

    Cosenza,
    Italy

    Site Not Available

  • Servizio Diabetologia, SOD Cardiologia Geriatrica - D.A.I. del Cuore e dei Vasi

    Firenze,
    Italy

    Site Not Available

  • Centro Diabetologico Malattie Metaboliche

    Mercato San Severino,
    Italy

    Site Not Available

  • Divisione Malattie Metaboliche e Diabetologia

    Milano,
    Italy

    Site Not Available

  • S. Semplice Dip. di Endocrinologia e Diabetologia Dip. di Medicina Interna

    Milano,
    Italy

    Site Not Available

  • U.O. Medicina II - Dip. Medicina Interna

    Milano,
    Italy

    Site Not Available

  • Unità Cardio-Metabolica e Trials Clinici Dipartimento di Medicina Interna

    Milano,
    Italy

    Site Not Available

  • U.O. Diabetologia

    Olbia,
    Italy

    Site Not Available

  • Centro per l'Aterosclerosi Dip. di Medicina Interna

    Roma,
    Italy

    Site Not Available

  • U.O. Endocrinologia e Diabetologia

    Roma,
    Italy

    Site Not Available

  • U.O.C. di Diabetologia c/o AUSL ROMA B - Sede Territoriale

    Roma,
    Italy

    Site Not Available

  • U.O.C. di Medicina Interna B - BMI02 Dip. Scienze Cliniche - II Clinica Medica

    Roma,
    Italy

    Site Not Available

  • S. S. di Diabetologia Dip. Med. Interna e Malattie Metaboliche

    Siena,
    Italy

    Site Not Available

  • S.C. Prevenzione-Riabilitazione Cardiologica presso ex-Dispensario

    Vibo Valentia,
    Italy

    Site Not Available

  • Eulji General Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Medical center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Holy Family Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou university hospital

    Suwon,
    Korea, Republic of

    Site Not Available

  • Daugavpils Regional Hospital

    Daugavpils, 5417
    Latvia

    Site Not Available

  • Primary Health Centre of Jaunliepaja

    Liepaja, 3401
    Latvia

    Site Not Available

  • Private practice of endocrinology

    Ogre, 5001
    Latvia

    Site Not Available

  • Center of Endocrinology

    Riga, 1002
    Latvia

    Site Not Available

  • Riga Outpatient Clinic "Dziednieciba"

    Riga, 1057
    Latvia

    Site Not Available

  • Talsi Clinical Hospital

    Talsi, 3201
    Latvia

    Site Not Available

  • Endocrinology Department of Vidzemes Hospital

    Valmiera, 4201
    Latvia

    Site Not Available

  • JSC "Klinikiniai sprendimai"

    Alytus, 63257
    Lithuania

    Site Not Available

  • Kaunas Dainavos Outpatient Clinic

    Kaunas, 51270
    Lithuania

    Site Not Available

  • Kaunas District Hospital

    Kaunas, 45130
    Lithuania

    Site Not Available

  • Kaunas Medical University Hospital

    Kaunas, 50009
    Lithuania

    Site Not Available

  • Kaunas Silainiai Outpatient Clinic

    Kaunas, 48259
    Lithuania

    Site Not Available

  • Private Endocrinology Clinic

    Vilnius, 09112
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santariskiu Clinics

    Vilnius, 08661
    Lithuania

    Site Not Available

  • Comité Bioetico para la Investigación Clínica S.C.

    Mexico City, Durango 03300
    Mexico

    Site Not Available

  • Unidad Metabolica y Cardiovascular S.C.

    Cuernavaca, Morelos.
    Mexico

    Site Not Available

  • Clínica Eugenio Sue

    Mexico City, Polanco Chapultepec 11550
    Mexico

    Site Not Available

  • Clínica de Diabetes de la Secretaria de Salud de Durango

    Durango, 34070
    Mexico

    Site Not Available

  • Arke Estudios Clinicos S.A. de C.V.

    Mexico City, 06700
    Mexico

    Site Not Available

  • Flattum legesenter

    Hønefoss, 3503
    Norway

    Site Not Available

  • Flattum legesenter

    Hønefoss, 3503
    Norway

    Site Not Available

  • Randesund Helsesenter

    Kristiansand,
    Norway

    Site Not Available

  • Oslo Universitetssykehus

    Oslo,
    Norway

    Site Not Available

  • Sinsenklinikken

    Oslo, 0580
    Norway

    Site Not Available

  • Hinnastrekanten legekontor

    Stavanger, 4020
    Norway

    Site Not Available

  • Vennesla legesenter

    Vennesla,
    Norway

    Site Not Available

  • Clinica San Miguel

    Arequipa,
    Peru

    Site Not Available

  • Clinica San Borja

    LIma,
    Peru

    Site Not Available

  • Clinica Geriatrica Militar

    Lima,
    Peru

    Site Not Available

  • Clinica Senor de los Milagros

    Lima,
    Peru

    Site Not Available

  • Hospital Nacional Cayetano Heredia

    Lima,
    Peru

    Site Not Available

  • Hospital Nacional Guillermo Almenara Irigoyen

    Lima,
    Peru

    Site Not Available

  • Bydgoskie Centrum Diabetologii i Endokrynologii

    Bydgoszcz, 85 822
    Poland

    Site Not Available

  • NZOZ "Specjalista" Sp z o. o.

    Kutno, 99 300
    Poland

    Site Not Available

  • Oddzial Chorob Wewnetrznych

    Mielec, 39 300
    Poland

    Site Not Available

  • Poradnia Lekarza Rodzinnego

    Poznan, 60 521
    Poland

    Site Not Available

  • PoznaÅ„ski OÅ›rodek Medyczny "NOVAMED"

    Poznań, 60 773
    Poland

    Site Not Available

  • Poznański Ośrodek Medyczny "NOVAMED"

    Poznań, 60 773
    Poland

    Site Not Available

  • CMI Cardiologie "Dr. Pop Calin Florin"

    Baia Mare, ap. 72
    Romania

    Site Not Available

  • "C. I. Parhon" Endocrinology Institute

    Bucharest, district 1
    Romania

    Site Not Available

  • Medical Centre "Sanatatea Ta" SRL

    Bucharest, district 2
    Romania

    Site Not Available

  • Anamed SRL

    Oradea, ap. 5
    Romania

    Site Not Available

  • Medical Practice SRL

    Oradea, ap. 3
    Romania

    Site Not Available

  • Emergency County Hospital Ploiesti

    Ploiesti, no. 100
    Romania

    Site Not Available

  • Policlinica "Dr. Citu"

    Timisoara, no. 27
    Romania

    Site Not Available

  • MEDISPEKTRUM s.r.o,

    Bratislava, Slovak Republic 811 02
    Slovakia

    Site Not Available

  • .Interna klinika, FN J.A. Reimana

    Presov, Slovak Republic 081 81
    Slovakia

    Site Not Available

  • Diabetologicka ambulancia,

    Bratislava, Slovakia Republic 81272
    Slovakia

    Site Not Available

  • Diabetologicka ambulancia

    Kosice, Slovakia Republic 040 01
    Slovakia

    Site Not Available

  • Diabetologicka ambulancia,

    Lucenec, Slovakia Republic 984 01
    Slovakia

    Site Not Available

  • NZZ Diabetologicka ambulancia

    Nove Zamky, Slovakia Republic 940 01
    Slovakia

    Site Not Available

  • Diabetes centrum s.r.o

    Trencin, Slovakia Republic 911 01
    Slovakia

    Site Not Available

  • Diabetologicka ambulancia,

    Zilina, Slovakia Republic 010 01
    Slovakia

    Site Not Available

  • Diametabol.s.r.o.,

    Bratislava, 821 07
    Slovakia

    Site Not Available

  • MUDr. Margita Kiripolska s.r.o

    Povazska Bystrica, 017 01
    Slovakia

    Site Not Available

  • Ambulatorio Militar Tipo III Paramacay. Avenida Universidad. Sector Santa Ana. Naguanagua.

    Valencia, Carabobo.
    Venezuela

    Site Not Available

  • Hospital Dr Miguel Perez Carreño. Servicio de Endocrinología. Sotano.

    Caracas,
    Venezuela

    Site Not Available

  • Hospital Militar Dr Carlos Arvelo. Final Av. José Angel Lamas. Servicio de Endocrinología.

    Caracas., Piso 4. Urb.
    Venezuela

    Site Not Available

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