Clinical trial NCT00860288: Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 1988
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 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:

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

Primary outcomes:
measure: To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of sitagliptin added to metformin after 24 weeks of treatment.
timeFrame: 24 weeks
measure: To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment.
timeFrame: 24 weeks
measure: To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of sitagliptin added to metformin.
timeFrame: 24 weeks
measure: To evaluate the safety and tolerability of vildagliptin compared to placebo and sitagliptin over 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.
timeFrame: 24 weeks
measure: To evaluate the long-term safety and tolerability of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.
timeFrame: 76 weeks
measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo and sitagliptin after 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.
timeFrame: 24 weeks
measure: To evaluate the long-term efficacy of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM.
timeFrame: 76 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Biomedicas
state: Santa Fe
city: Rosario
country: Argentina
facility: Grupo Colaborative Rosario
state: Santa Fe
city: Buenos Aires,
country: Argentina
facility: Fundación de Estudios Farmacológicos y de Medicamentos
city: Buenos Aires
country: Argentina
facility: Grupo Medico Alem
city: Buenos Aires
country: Argentina
facility: DIM Clinical Privada
city: Buenos Aires
country: Argentina
facility: Clinica Medica Sin Internacion
city: Graz
country: Austria
facility: Universitaetsklinik Graz medizinische Universitaetsklinik;
city: Salzburg
country: Austria
facility: LKH Salzburg Landesklinik fuer Innere Medizin I
city: Wiener Neustadt
country: Austria
facility: Kindlergasse 4
city: Wiener Neustadt
country: Austria
facility: Kindlergasse 4
city: Wien
country: Austria
facility: Millergasse 7
city: Wien
country: Austria
facility: Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment
city: Sint-Gillis-Waas
country: Belgium
facility: Private Practice Diabetology (Dr. Coucke)
state: Sint-Niklaasstraat 117
city: De Pinte
country: Belgium
facility: Private Practice Cardiology (Dr. Hollanders)
city: Genk
country: Belgium
facility: Private Practice (Vernijns)
city: Gozee
country: Belgium
facility: Private Practice (Dr. De Meulemeester)
city: Hasselt
country: Belgium
facility: Huisartsenpraktijk Hygeia
city: Oostham
country: Belgium
facility: Private Practice (Dr. Jaak Mortelmans)
city: Helsinki
country: Finland
facility: Lihavuustutkimusyksikkö
city: Helsinki
country: Finland
facility: Mehiläinen Töölö Diabetesklinikka
city: Kuopio
country: Finland
facility: Terveystalo Kuopio
city: Lahti
country: Finland
facility: Mehiläinen Lahti
city: Oulu
country: Finland
facility: ODL Terveys Oy, Tutkimusyksikkö,
city: Riihimäki
country: Finland
facility: Mehiläinen Riihimäki
city: Tampere
country: Finland
facility: Terveystalo Tampereen työterveys Kalmar
city: Vantaa
country: Finland
facility: Myyrmäen terveysasema
city: Augsburg
country: Germany
facility: Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger
city: Augsburg
country: Germany
facility: Praxis Dr. Med. Kurt Rack
city: Bad Kreuznach
country: Germany
facility: Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Buch
city: Berlin
country: Germany
facility: Praxis Dr. Med. Ulrike Venschott-Jordan
city: Berlin
country: Germany
facility: Praxis Dr. Med. Monika Kiper
city: Berlin
country: Germany
facility: Praxis Dr. Med. Christina Bondke
city: Bibertal
country: Germany
facility: Bibertal Klinik
city: Diez
country: Germany
facility: Gemeinschaftspraxis Dr. med. Ali Boustani
city: Dorsten
country: Germany
facility: Facharzt fuer Allgemeinmedizin
city: Einbeck
country: Germany
facility: Praxis Dr. Med. Anwar Ansari
city: Essen
country: Germany
facility: Hausaerzte am Stern Dr. Med. Blume / Dr. Med. Garanin
city: Essen
country: Germany
facility: Praxis Dr. Med. Roland Kutzke
city: Essen
country: Germany
facility: Praxis Dr. Med. Thorsten Rau
city: Falkensee
country: Germany
facility: Praxis Dr. Med. Joerg Luedemann / Facharzt fuer Innere Medizin - Diabetologie
city: Frankfurt
country: Germany
facility: Praxis Dr. Med. Daniela Freise
city: Freital
country: Germany
facility: Dial.-Med. Kerstin Steinbach
city: Fulda
country: Germany
facility: Gemeinschaftspraxis
city: Grimma
country: Germany
facility: Praxis Dr. Med. Wolfgang Krause
city: Hagenow
country: Germany
facility: Krankenhaus Hagenow, Innere Medizin
city: Hamburg
country: Germany
facility: MVZ-medicum Hamburg
city: Hamburg
country: Germany
facility: Diabetes-Zentrum Wandsbek
city: Herne
country: Germany
facility: Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle
city: Hildesheim
country: Germany
facility: Praxis Dr. Med. Helmut Anderten
city: Kahla
country: Germany
facility: Praxis Dr. Med. Juergen Landschulze
city: Karlsruhe
country: Germany
facility: Praxis Dr. Med. Julia Chevts
city: Kassel
country: Germany
facility: Praxis Dr. Med. Hans-Helmut Seibert
city: Koeln
country: Germany
facility: Praxis Dr. Med. Claudia Ulbrich
city: Kuenzing
country: Germany
facility: Dres. Klein/Minnich
city: Leipzig
country: Germany
facility: Praxis Dr. Med. Birgit Hoene
city: Luebeck
country: Germany
facility: Pro Scientia med
city: Meissen
country: Germany
facility: Diabetes Schwerpunktpraxis
city: Muehldorf
country: Germany
facility: Praxis Dres. Prohaska / Lindner
city: Muenchen
country: Germany
facility: Praxis Dr. Med. Claus-Michael Grimm
city: Muenster
country: Germany
facility: Praxis Dr. Fischer & Dr. Keuthage
city: Neumunster
country: Germany
facility: Gemeinschaftspraxis Dr. Uwe Böckmann/Dr. med. Maren Molkewehrum
city: Oberhausen
country: Germany
facility: Praxis Dr. Med. Joachim Etter
city: Potsdam
country: Germany
facility: IkFE Studiencenter Potsdam GMBH i.G.
city: Quakenbrueck
country: Germany
facility: Diabetes Center Quakenbrueck
city: Reinfeld
country: Germany
facility: Praxis Dr. Altwicker, Dr. Kanis
city: Rothenburg
country: Germany
facility: Praxis Dr. Med. Ulrich Aigner
city: Schoenberg
country: Germany
facility: Praxis Dr. Med. Sabine Sedl
city: Schrobenhausen
country: Germany
facility: Dres. Hiltensperger & Schaal
city: Schwabenheim
country: Germany
facility: Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer
city: Stuttgart
country: Germany
facility: Praxis Dr. Med. Ottmar Herfert
city: Veitsbronn
country: Germany
facility: Praxis Dr. Med. Doru Popa
city: Viernheim
country: Germany
facility: Gemeinschaftspraxis Gerhard Steinmaier und Dr. Med. Werner Bauer
city: Wangen
country: Germany
facility: Gemeinschaftspraxis Sauter
city: Weissenhorn
country: Germany
facility: Praxis Dr. Med. Rudolf Matthias Remppis
city: Welzheim
country: Germany
facility: Praxis Dr. Med. Peter Genthner
city: Wetzlar
country: Germany
facility: Gemeinschaftspraxis Dr. med. Reinhold Schneider und Christine Schneider
city: Athens
country: Greece
facility: Laiko General Hospital,
city: Larisa
country: Greece
facility: Lamia General Hospital
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
city: Guatemala City
country: Guatemala
facility: Clínica y Hospital Colón del Paciente Diabético
city: Guatemala City
country: Guatemala
facility: Endonutri S.A
city: Guatemala City
country: Guatemala
facility: Clínica y Hospital Colón del Paciente Diabético
city: Guatemala City
country: Guatemala
facility: Clinica Dr. Erick Turcios
city: Guatemala City
country: Guatemala
facility: Endonutri S. A.
city: Guatemala City
country: Guatemala
facility: Clinica Dr. Sergio Bran
city: Budapest
country: Hungary
facility: Szent Margit Hospita
city: Budapest
country: Hungary
facility: Károlyi Sándor Hospital
city: Budapest
country: Hungary
facility: Szent Imre Hospital
city: Csongrád
country: Hungary
facility: Konszenzusplusz Kft.
city: Győr
country: Hungary
facility: Petz Aladar Hospital
city: Nyíregyháza
country: Hungary
facility: Jósa Andras Hospital
city: Szeged
country: Hungary
facility: Szte-Áok I
city: Szekszárd
country: Hungary
facility: Balassa Janos Hospital
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Hospital
city: Bangalore
country: India
facility: Manipal Hospital,
state: Karantaka
city: Trivandrum
country: India
facility: Health and Research Centre
state: Kerela
city: Indore
country: India
facility: Diabetes Thyroid Hormone Research Institute Pvt Ltd.
state: Madhya Pradesh
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
state: Tamil Nadu
city: Chennai
country: India
facility: M. V. Hosp for Diabetes P. Ltd. 4,
city: Hyderabaad
country: India
facility: Medicity Hospital
city: Hyderabaad
country: India
facility: Nizam's institute of medical sciences,
city: Jaipur
country: India
facility: S. R. Kalla Memorial gastro and general hosp,
city: Vellore
country: India
facility: Christian Medical College,
city: Rishon Le Zion
country: Israel
facility: Maccabi Healthcare Services
city: Safed
country: Israel
facility: Ziv Medical Center
city: Arenzano
country: Italy
facility: U.O.C. di Diabetologia e Malattie Metaboliche
city: Bergamo
country: Italy
facility: U.S.C. di Endocrinologia (Ingresso 13 - piano 2) Dip. di Medicina
city: Campobasso
country: Italy
facility: U.O.C. Diabetologia Endocrinologia Dip. Medico
city: Casorate Primo
country: Italy
facility: U.O. Medicina Generale
city: Catania
country: Italy
facility: I Divisione Medicina
city: Chieri
country: Italy
facility: U.O. Malattie Metaboliche e Diabetologia
city: Cosenza
country: Italy
facility: U.O.C. di Medicina d'Urgenza e Pronto Soccorso
city: Firenze
country: Italy
facility: Servizio Diabetologia, SOD Cardiologia Geriatrica - D.A.I. del Cuore e dei Vasi
city: Mercato San Severino
country: Italy
facility: Centro Diabetologico Malattie Metaboliche
city: Milano
country: Italy
facility: Divisione Malattie Metaboliche e Diabetologia
city: Milano
country: Italy
facility: S. Semplice Dip. di Endocrinologia e Diabetologia Dip. di Medicina Interna
city: Milano
country: Italy
facility: U.O. Medicina II - Dip. Medicina Interna
city: Milano
country: Italy
facility: Unità Cardio-Metabolica e Trials Clinici Dipartimento di Medicina Interna
city: Olbia
country: Italy
facility: U.O. Diabetologia
city: Roma
country: Italy
facility: Centro per l'Aterosclerosi Dip. di Medicina Interna
city: Roma
country: Italy
facility: U.O. Endocrinologia e Diabetologia
city: Roma
country: Italy
facility: U.O.C. di Diabetologia c/o AUSL ROMA B - Sede Territoriale
city: Roma
country: Italy
facility: U.O.C. di Medicina Interna B - BMI02 Dip. Scienze Cliniche - II Clinica Medica
city: Siena
country: Italy
facility: S. S. di Diabetologia Dip. Med. Interna e Malattie Metaboliche
city: Vibo Valentia
country: Italy
facility: S.C. Prevenzione-Riabilitazione Cardiologica presso ex-Dispensario
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Holy Family Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou university hospital
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Liepaja
country: Latvia
facility: Primary Health Centre of Jaunliepaja
city: Ogre
country: Latvia
facility: Private practice of endocrinology
city: Riga
country: Latvia
facility: Center of Endocrinology
city: Riga
country: Latvia
facility: Riga Outpatient Clinic "Dziednieciba"
city: Talsi
country: Latvia
facility: Talsi Clinical Hospital
city: Valmiera
country: Latvia
facility: Endocrinology Department of Vidzemes Hospital
city: Alytus
country: Lithuania
facility: JSC "Klinikiniai sprendimai"
city: Kaunas
country: Lithuania
facility: Kaunas District Hospital
city: Kaunas
country: Lithuania
facility: Kaunas Silainiai Outpatient Clinic
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Hospital
city: Kaunas
country: Lithuania
facility: Kaunas Dainavos Outpatient Clinic
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinics
city: Vilnius
country: Lithuania
facility: Private Endocrinology Clinic
city: Mexico City
country: Mexico
facility: Comité Bioetico para la Investigación Clínica S.C.
state: Durango
city: Cuernavaca
country: Mexico
facility: Unidad Metabolica y Cardiovascular S.C.
state: Morelos.
city: Mexico City
country: Mexico
facility: Clínica Eugenio Sue
state: Polanco Chapultepec
city: Durango
country: Mexico
facility: Clínica de Diabetes de la Secretaria de Salud de Durango
city: Mexico City
country: Mexico
facility: Arke Estudios Clinicos S.A. de C.V.
city: Hønefoss
country: Norway
facility: Flattum legesenter
city: Kristiansand
country: Norway
facility: Randesund Helsesenter
city: Oslo
country: Norway
facility: Sinsenklinikken
city: Oslo
country: Norway
facility: Oslo Universitetssykehus
city: Stavanger
country: Norway
facility: Hinnastrekanten legekontor
city: Vennesla
country: Norway
facility: Vennesla legesenter
city: Arequipa
country: Peru
facility: Clinica San Miguel
city: Lima
country: Peru
facility: Clinica Geriatrica Militar
city: LIma
country: Peru
facility: Clinica San Borja
city: Lima
country: Peru
facility: Clinica Senor de los Milagros
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen
city: Bydgoszcz
country: Poland
facility: Bydgoskie Centrum Diabetologii i Endokrynologii
city: Kutno
country: Poland
facility: NZOZ "Specjalista" Sp z o. o.
city: Mielec
country: Poland
facility: Oddzial Chorob Wewnetrznych
city: Poznan
country: Poland
facility: Poradnia Lekarza Rodzinnego
city: Poznań
country: Poland
facility: Poznański Ośrodek Medyczny "NOVAMED"
city: Baia Mare
country: Romania
facility: CMI Cardiologie "Dr. Pop Calin Florin"
city: Bucharest
country: Romania
facility: "C. I. Parhon" Endocrinology Institute
city: Bucharest
country: Romania
facility: Medical Centre "Sanatatea Ta" SRL
city: Oradea
country: Romania
facility: Medical Practice SRL
city: Oradea
country: Romania
facility: Anamed SRL
city: Ploiesti
country: Romania
facility: Emergency County Hospital Ploiesti
city: Timisoara
country: Romania
facility: Policlinica "Dr. Citu"
city: Bratislava
country: Slovakia
facility: MEDISPEKTRUM s.r.o,
state: Slovak Republic
city: Presov
country: Slovakia
facility: .Interna klinika, FN J.A. Reimana
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Diabetologicka ambulancia,
state: Slovakia Republic
city: Kosice
country: Slovakia
facility: Diabetologicka ambulancia
state: Slovakia Republic
city: Lucenec
country: Slovakia
facility: Diabetologicka ambulancia,
state: Slovakia Republic
city: Nove Zamky
country: Slovakia
facility: NZZ Diabetologicka ambulancia
state: Slovakia Republic
city: Trencin
country: Slovakia
facility: Diabetes centrum s.r.o
state: Slovakia Republic
city: Zilina
country: Slovakia
facility: Diabetologicka ambulancia,
state: Slovakia Republic
city: Bratislava
country: Slovakia
facility: Diametabol.s.r.o.,
city: Povazska Bystrica
country: Slovakia
facility: MUDr. Margita Kiripolska s.r.o
city: Valencia
country: Venezuela
facility: Ambulatorio Militar Tipo III Paramacay. Avenida Universidad. Sector Santa Ana. Naguanagua.
state: Carabobo.
city: Caracas.
country: Venezuela
facility: Hospital Militar Dr Carlos Arvelo. Final Av. José Angel Lamas. Servicio de Endocrinología.
city: Caracas
country: Venezuela
facility: Hospital Dr Miguel Perez Carreño. Servicio de Endocrinología. Sotano.
Study officials:
References: