Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00860288
- Lead Sponsor
- Novartis Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1988
- 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
- Pregnant or nursing (lactating) women
- FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sitagliptin Sitagliptin - Vildagliptin Dose 2 Metformin - Placebo Placebo - Vildagliptin Dose 1 Vildagliptin - Vildagliptin Dose 1 Metformin - Vildagliptin Dose 2 Vildagliptin - Placebo Metformin - Sitagliptin Metformin -
- Primary Outcome Measures
Name Time Method 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 24 weeks
- Secondary Outcome Measures
Name Time Method 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. 24 weeks 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. 24 weeks 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. 76 weeks 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. 24 weeks 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. 24 weeks 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. 24 weeks 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. 76 weeks
Trial Locations
- Locations (183)
Ajou university hospital
🇰🇷Suwon, Korea, Republic of
Daugavpils Regional Hospital
🇱🇻Daugavpils, Latvia
Talsi Clinical Hospital
🇱🇻Talsi, Latvia
Centro per l'Aterosclerosi Dip. di Medicina Interna
🇮🇹Roma, Italy
The Catholic University of Korea Holy Family Hospital
🇰🇷Seoul, Korea, Republic of
Private practice of endocrinology
🇱🇻Ogre, Latvia
Riga Outpatient Clinic "Dziednieciba"
🇱🇻Riga, Latvia
Endocrinology Department of Vidzemes Hospital
🇱🇻Valmiera, Latvia
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Medical center
🇰🇷Seoul, Korea, Republic of
Eulji General Hospital
🇰🇷Seoul, Korea, Republic of
U.O. Endocrinologia e Diabetologia
🇮🇹Roma, Italy
Sinsenklinikken
🇳🇴Oslo, Norway
Vennesla legesenter
🇳🇴Vennesla, Norway
Bydgoskie Centrum Diabetologii i Endokrynologii
🇵🇱Bydgoszcz, Poland
Medical Centre "Sanatatea Ta" SRL
🇷🇴Bucharest, Romania
Hinnastrekanten legekontor
🇳🇴Stavanger, Norway
Clinica San Miguel
🇵🇪Arequipa, Peru
Clinica Geriatrica Militar
🇵🇪Lima, Peru
Poradnia Lekarza Rodzinnego
🇵🇱Poznan, Poland
Grupo Medico Alem
🇦🇷Buenos Aires, Argentina
Universitaetsklinik Graz medizinische Universitaetsklinik;
🇦🇹Graz, Austria
Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment
🇦🇹Wien, Austria
Private Practice Cardiology (Dr. Hollanders)
🇧🇪De Pinte, Belgium
Private Practice (Vernijns)
🇧🇪Genk, Belgium
Private Practice Diabetology (Dr. Coucke)
🇧🇪Sint-Gillis-Waas, Sint-Niklaasstraat 117, Belgium
Terveystalo Kuopio
🇫🇮Kuopio, Finland
Mehiläinen Lahti
🇫🇮Lahti, Finland
Praxis Dr. Med. Kurt Rack
🇩🇪Augsburg, Germany
Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht
🇩🇪Bad Kreuznach, Germany
Bibertal Klinik
🇩🇪Bibertal, Germany
Facharzt fuer Allgemeinmedizin
🇩🇪Dorsten, Germany
Gemeinschaftspraxis Dr. med. Ali Boustani
🇩🇪Diez, 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
Krankenhaus Hagenow, Innere Medizin
🇩🇪Hagenow, Germany
Praxis Dr. Med. Wolfgang Krause
🇩🇪Grimma, Germany
Praxis Dr. Med. Daniela Freise
🇩🇪Frankfurt, Germany
Dial.-Med. Kerstin Steinbach
🇩🇪Freital, Germany
Gemeinschaftspraxis
🇩🇪Fulda, Germany
Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle
🇩🇪Herne, Germany
MVZ-medicum Hamburg
🇩🇪Hamburg, Germany
Diabetes-Zentrum Wandsbek
🇩🇪Hamburg, Germany
Praxis Dr. Med. Helmut Anderten
🇩🇪Hildesheim, Germany
Praxis Dr. Med. Juergen Landschulze
🇩🇪Kahla, Germany
Praxis Dr. Med. Hans-Helmut Seibert
🇩🇪Kassel, Germany
Praxis Dr. Med. Claudia Ulbrich
🇩🇪Koeln, Germany
Praxis Dr. Med. Birgit Hoene
🇩🇪Leipzig, Germany
Pro Scientia med
🇩🇪Luebeck, Germany
Diabetes Schwerpunktpraxis
🇩🇪Meissen, Germany
Praxis Dres. Prohaska / Lindner
🇩🇪Muehldorf, Germany
Praxis Dr. Med. Claus-Michael Grimm
🇩🇪Muenchen, Germany
Praxis Dr. Fischer & Dr. Keuthage
🇩🇪Muenster, Germany
Gemeinschaftspraxis Dr. Uwe Böckmann/Dr. med. Maren Molkewehrum
🇩🇪Neumunster, Germany
Praxis Dr. Med. Joachim Etter
🇩🇪Oberhausen, Germany
IkFE Studiencenter Potsdam GMBH i.G.
🇩🇪Potsdam, Germany
Diabetes Center Quakenbrueck
🇩🇪Quakenbrueck, Germany
Praxis Dr. Med. Ulrich Aigner
🇩🇪Rothenburg, Germany
Praxis Dr. Med. Sabine Sedl
🇩🇪Schoenberg, Germany
Dres. Hiltensperger & Schaal
🇩🇪Schrobenhausen, 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 Dr. med. Reinhold Schneider und Christine Schneider
🇩🇪Wetzlar, Germany
Praxis Dr. Med. Rudolf Matthias Remppis
🇩🇪Weissenhorn, Germany
Gemeinschaftspraxis Sauter
🇩🇪Wangen, Germany
Praxis Dr. Med. Peter Genthner
🇩🇪Welzheim, Germany
Lamia General Hospital
🇬🇷Larisa, Greece
Papageorgiou General Hospital
🇬🇷Thessaloniki, Greece
Endonutri S.A
🇬🇹Guatemala City, Guatemala
Endonutri S. A.
🇬🇹Guatemala City, Guatemala
Szent Margit Hospita
🇭🇺Budapest, Hungary
Petz Aladar Hospital
🇭🇺Győr, Hungary
Konszenzusplusz Kft.
🇭🇺Csongrád, Hungary
Madras Diabetes Research Foundation
🇮🇳Chennai, Tamil Nadu, India
Maccabi Healthcare Services
🇮🇱Rishon Le Zion, Israel
Unità Cardio-Metabolica e Trials Clinici Dipartimento di Medicina Interna
🇮🇹Milano, Italy
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
S. Semplice Dip. di Endocrinologia e Diabetologia Dip. di Medicina Interna
🇮🇹Milano, 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
🇮🇹Firenze, Italy
Centro Diabetologico Malattie Metaboliche
🇮🇹Mercato San Severino, Italy
Divisione Malattie Metaboliche e Diabetologia
🇮🇹Milano, Italy
U.O. Medicina II - Dip. Medicina Interna
🇮🇹Milano, Italy
S. S. di Diabetologia Dip. Med. Interna e Malattie Metaboliche
🇮🇹Siena, Italy
U.O. Diabetologia
🇮🇹Olbia, Italy
S.C. Prevenzione-Riabilitazione Cardiologica presso ex-Dispensario
🇮🇹Vibo Valentia, 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
Kindlergasse 4
🇦🇹Wiener Neustadt, Austria
ODL Terveys Oy, Tutkimusyksikkö,
🇫🇮Oulu, Finland
DIM Clinical Privada
🇦🇷Buenos Aires, Argentina
Clinica Medica Sin Internacion
🇦🇷Buenos Aires, Argentina
Huisartsenpraktijk Hygeia
🇧🇪Hasselt, Belgium
Lihavuustutkimusyksikkö
🇫🇮Helsinki, Finland
Terveystalo Tampereen työterveys Kalmar
🇫🇮Tampere, Finland
Instituto de Investigaciones Biomedicas
🇦🇷Buenos Aires, Santa Fe, Argentina
Fundación de Estudios Farmacológicos y de Medicamentos
🇦🇷Buenos Aires,, Argentina
Millergasse 7
🇦🇹Wien, Austria
Private Practice (Dr. De Meulemeester)
🇧🇪Gozee, Belgium
Mehiläinen Riihimäki
🇫🇮Riihimäki, Finland
Grupo Colaborative Rosario
🇦🇷Rosario, Santa Fe, Argentina
LKH Salzburg Landesklinik fuer Innere Medizin I
🇦🇹Salzburg, Austria
Private Practice (Dr. Jaak Mortelmans)
🇧🇪Oostham, Belgium
Mehiläinen Töölö Diabetesklinikka
🇫🇮Helsinki, Finland
Clínica y Hospital Colón del Paciente Diabético
🇬🇹Guatemala City, Guatemala
Myyrmäen terveysasema
🇫🇮Vantaa, Finland
Clinica Dr. Erick Turcios
🇬🇹Guatemala City, Guatemala
Medicity Hospital
🇮🇳Hyderabaad, India
S. R. Kalla Memorial gastro and general hosp,
🇮🇳Jaipur, India
Ziv Medical Center
🇮🇱Safed, Israel
Center of Endocrinology
🇱🇻Riga, Latvia
Kaunas District Hospital
🇱🇹Kaunas, Lithuania
Kaunas Silainiai Outpatient Clinic
🇱🇹Kaunas, Lithuania
Clínica de Diabetes de la Secretaria de Salud de Durango
🇲🇽Durango, Mexico
Szent Imre Hospital
🇭🇺Budapest, Hungary
Laiko General Hospital,
🇬🇷Athens, Greece
Diabetes Thyroid Hormone Research Institute Pvt Ltd.
🇮🇳Indore, Madhya Pradesh, India
Jósa Andras Hospital
🇭🇺Nyíregyháza, Hungary
Clinica Dr. Sergio Bran
🇬🇹Guatemala City, Guatemala
Zala Megyei Hospital
🇭🇺Zalaegerszeg, Hungary
Manipal Hospital,
🇮🇳Bangalore, Karantaka, India
M. V. Hosp for Diabetes P. Ltd. 4,
🇮🇳Chennai, India
Kaunas Dainavos Outpatient Clinic
🇱🇹Kaunas, Lithuania
Clínica Eugenio Sue
🇲🇽Mexico City, Polanco Chapultepec, Mexico
Anamed SRL
🇷🇴Oradea, Romania
Emergency County Hospital Ploiesti
🇷🇴Ploiesti, Romania
MEDISPEKTRUM s.r.o,
🇸🇰Bratislava, Slovak Republic, Slovakia
Diabetologicka ambulancia,
🇸🇰Zilina, Slovakia Republic, Slovakia
Károlyi Sándor Hospital
🇭🇺Budapest, Hungary
Szte-Áok I
🇭🇺Szeged, Hungary
Balassa Janos Hospital
🇭🇺Szekszárd, Hungary
Health and Research Centre
🇮🇳Trivandrum, Kerela, India
Nizam's institute of medical sciences,
🇮🇳Hyderabaad, India
Kaunas Medical University Hospital
🇱🇹Kaunas, Lithuania
Christian Medical College,
🇮🇳Vellore, India
JSC "Klinikiniai sprendimai"
🇱🇹Alytus, Lithuania
Vilnius University Hospital Santariskiu Clinics
🇱🇹Vilnius, Lithuania
Private Endocrinology Clinic
🇱🇹Vilnius, Lithuania
Unidad Metabolica y Cardiovascular S.C.
🇲🇽Cuernavaca, Morelos., Mexico
Clinica Senor de los Milagros
🇵🇪Lima, Peru
Primary Health Centre of Jaunliepaja
🇱🇻Liepaja, Latvia
Flattum legesenter
🇳🇴Hønefoss, Norway
Poznański Ośrodek Medyczny "NOVAMED"
🇵🇱Poznań, Poland
.Interna klinika, FN J.A. Reimana
🇸🇰Presov, Slovak Republic, Slovakia
Oslo Universitetssykehus
🇳🇴Oslo, Norway
Comité Bioetico para la Investigación Clínica S.C.
🇲🇽Mexico City, Durango, Mexico
Arke Estudios Clinicos S.A. de C.V.
🇲🇽Mexico City, Mexico
Randesund Helsesenter
🇳🇴Kristiansand, Norway
Clinica San Borja
🇵🇪LIma, Peru
Medical Practice SRL
🇷🇴Oradea, Romania
Diabetologicka ambulancia
🇸🇰Kosice, Slovakia Republic, Slovakia
Diametabol.s.r.o.,
🇸🇰Bratislava, Slovakia
Hospital Militar Dr Carlos Arvelo. Final Av. José Angel Lamas. Servicio de Endocrinología.
🇻🇪Caracas., Venezuela
Hospital Nacional Cayetano Heredia
🇵🇪Lima, Peru
Hospital Nacional Guillermo Almenara Irigoyen
🇵🇪Lima, Peru
NZOZ "Specjalista" Sp z o. o.
🇵🇱Kutno, Poland
"C. I. Parhon" Endocrinology Institute
🇷🇴Bucharest, Romania
Policlinica "Dr. Citu"
🇷🇴Timisoara, Romania
Oddzial Chorob Wewnetrznych
🇵🇱Mielec, Poland
CMI Cardiologie "Dr. Pop Calin Florin"
🇷🇴Baia Mare, Romania
MUDr. Margita Kiripolska s.r.o
🇸🇰Povazska Bystrica, Slovakia
NZZ Diabetologicka ambulancia
🇸🇰Nove Zamky, Slovakia Republic, Slovakia
Diabetes centrum s.r.o
🇸🇰Trencin, Slovakia Republic, Slovakia
Ambulatorio Militar Tipo III Paramacay. Avenida Universidad. Sector Santa Ana. Naguanagua.
🇻🇪Valencia, Carabobo., Venezuela
Hospital Dr Miguel Perez Carreño. Servicio de Endocrinología. Sotano.
🇻🇪Caracas, Venezuela
Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger
🇩🇪Augsburg, 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
Dres. Klein/Minnich
🇩🇪Kuenzing, Germany
Praxis Dr. Med. Julia Chevts
🇩🇪Karlsruhe, Germany
Praxis Dr. Altwicker, Dr. Kanis
🇩🇪Reinfeld, Germany
Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer
🇩🇪Schwabenheim, Germany