Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
1 other identifier
interventional
1,988
21 countries
187
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Feb 2009
Typical duration for phase_2 diabetes-mellitus-type-2
187 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 10, 2009
CompletedFirst Posted
Study publicly available on registry
March 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedDecember 29, 2020
January 1, 2013
2.1 years
March 10, 2009
December 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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 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 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
- +2 more secondary outcomes
Study Arms (4)
Vildagliptin Dose 1
EXPERIMENTALVildagliptin Dose 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORSitagliptin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or nursing (lactating) women
- FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (187)
Instituto de Investigaciones Biomedicas
Buenos Aires, Santa Fe Province, 3000FNF, Argentina
Grupo Colaborative Rosario
Rosario, Santa Fe Province, S2002OJP, Argentina
Grupo Medico Alem
Buenos Aires, B1642DCD, Argentina
DIM Clinical Privada
Buenos Aires, B1704ETD, Argentina
Clinica Medica Sin Internacion
Buenos Aires, B1824KAJ, Argentina
Fundación de Estudios Farmacológicos y de Medicamentos
Buenos Aires, C1027AAP, Argentina
Universitaetsklinik Graz medizinische Universitaetsklinik;
Graz, 8036, Austria
LKH Salzburg Landesklinik fuer Innere Medizin I
Salzburg, 5020, Austria
Millergasse 7
Vienna, 1060, Austria
Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment
Vienna, 1140, Austria
Kindlergasse 4
Wiener Neustadt, 2700, Austria
Kindlergasse 4
Wiener Neustadt, Austria
Private Practice Diabetology (Dr. Coucke)
Sint-Gillis-Waas, Sint-Niklaasstraat 117, 9170, Belgium
Private Practice Cardiology (Dr. Hollanders)
De Pinte, 9840, Belgium
Private Practice (Vernijns)
Genk, 3600, Belgium
Private Practice (Dr. De Meulemeester)
Gozée, 6534, Belgium
Huisartsenpraktijk Hygeia
Hasselt, 3500, Belgium
Private Practice (Dr. Jaak Mortelmans)
Oostham, 3945, Belgium
Lihavuustutkimusyksikkö
Helsinki, 2 A 2 00270, Finland
Mehiläinen Töölö Diabetesklinikka
Helsinki, 47 A 00260, Finland
Terveystalo Kuopio
Kuopio, 70100, Finland
Mehiläinen Lahti
Lahti, 6 C 15110, Finland
ODL Terveys Oy, Tutkimusyksikkö,
Oulu, 90100, Finland
Mehiläinen Riihimäki
Riihimäki, 11130, Finland
Terveystalo Tampereen työterveys Kalmar
Tampere, 33900, Finland
Myyrmäen terveysasema
Vantaa, 01600, Finland
Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger
Augsburg, 86150, Germany
Praxis Dr. Med. Kurt Rack
Augsburg, 86150, Germany
Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht
Bad Kreuznach, 55545, Germany
Klinische Forschung Berlin-Buch
Berlin, 10117, Germany
Praxis Dr. Med. Ulrike Venschott-Jordan
Berlin, 12247, Germany
Praxis Dr. Med. Monika Kiper
Berlin, 12347, Germany
Praxis Dr. Med. Christina Bondke
Berlin, 13189, Germany
Bibertal Klinik
Bibertal, 89346, Germany
Praxis Dr. Med. Claudia Ulbrich
Cologne, 50823, Germany
Gemeinschaftspraxis Dr. med. Ali Boustani
Diez, 65582, Germany
Facharzt fuer Allgemeinmedizin
Dorsten, 46282, Germany
Praxis Dr. Med. Anwar Ansari
Einbeck, 37574, Germany
Hausaerzte am Stern Dr. Med. Blume / Dr. Med. Garanin
Essen, 45130, Germany
Praxis Dr. Med. Roland Kutzke
Essen, 45144, Germany
Praxis Dr. Med. Thorsten Rau
Essen, 45276, Germany
Praxis Dr. Med. Joerg Luedemann / Facharzt fuer Innere Medizin - Diabetologie
Falkensee, 14612, Germany
Praxis Dr. Med. Daniela Freise
Frankfurt, 60599, Germany
Dial.-Med. Kerstin Steinbach
Freital, 01705, Germany
Gemeinschaftspraxis
Fulda, 36037, Germany
Praxis Dr. Med. Wolfgang Krause
Grimma, 04668, Germany
Krankenhaus Hagenow, Innere Medizin
Hagenow, 19230, Germany
MVZ-medicum Hamburg
Hamburg, 20097, Germany
Diabetes-Zentrum Wandsbek
Hamburg, 22041, Germany
Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle
Herne, 44653, Germany
Praxis Dr. Med. Helmut Anderten
Hildesheim, 31139, Germany
Praxis Dr. Med. Juergen Landschulze
Kahla, 07768, Germany
Praxis Dr. Med. Julia Chevts
Karlsruhe, 76199, Germany
Praxis Dr. Med. Hans-Helmut Seibert
Kassel, 34125, Germany
Dres. Klein/Minnich
Künzing, 94550, Germany
Praxis Dr. Med. Birgit Hoene
Leipzig, Germany
Pro Scientia med
Lübeck, 23562, Germany
Diabetes Schwerpunktpraxis
Meissen, 01662, Germany
Praxis Dres. Prohaska / Lindner
Mühldorf, 84453, Germany
Praxis Dr. Med. Claus-Michael Grimm
München, 81373, Germany
Praxis Dr. Fischer & Dr. Keuthage
Münster, 48153, Germany
Gemeinschaftspraxis Dr. Uwe Böckmann/Dr. med. Maren Molkewehrum
Neumünster, 24534, Germany
Praxis Dr. Med. Joachim Etter
Oberhausen, 46049, Germany
IkFE Studiencenter Potsdam GMBH i.G.
Potsdam, 14469, Germany
Diabetes Center Quakenbrueck
Quakenbrück, 49610, Germany
Praxis Dr. Altwicker, Dr. Kanis
Reinfeld, 23858, Germany
Praxis Dr. Med. Ulrich Aigner
Rothenburg, Germany
Praxis Dr. Med. Sabine Sedl
Schönberg, 23923, Germany
Dres. Hiltensperger & Schaal
Schrobenhausen, 86529, Germany
Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer
Schwabenheim, 55270, Germany
Praxis Dr. Med. Ottmar Herfert
Stuttgart, 70469, Germany
Praxis Dr. Med. Doru Popa
Veitsbronn, 90587, Germany
Gemeinschaftspraxis Gerhard Steinmaier und Dr. Med. Werner Bauer
Viernheim, 68519, Germany
Gemeinschaftspraxis Sauter
Wangen, 88239, Germany
Praxis Dr. Med. Rudolf Matthias Remppis
Weißenhorn, 89264, Germany
Praxis Dr. Med. Peter Genthner
Welzheim, 73642, Germany
Gemeinschaftspraxis Dr. med. Reinhold Schneider und Christine Schneider
Wetzlar, 35584, Germany
Laiko General Hospital,
Athens, GR11527, Greece
Lamia General Hospital
Larissa, GR 35100, Greece
Papageorgiou General Hospital
Thessaloniki, GR56403, Greece
Clínica y Hospital Colón del Paciente Diabético
Guatemala City, 01001, Guatemala
Endonutri S.A
Guatemala City, 01010, Guatemala
Clínica y Hospital Colón del Paciente Diabético
Guatemala City, 11-49, Guatemala
Clinica Dr. Erick Turcios
Guatemala City, Oficina 1114, Guatemala
Endonutri S. A.
Guatemala City, Oficina 909, Guatemala
Clinica Dr. Sergio Bran
Guatemala City, Guatemala
Szent Margit Hospita
Budapest, 1032, Hungary
Károlyi Sándor Hospital
Budapest, 1041, Hungary
Szent Imre Hospital
Budapest, 1115, Hungary
Konszenzusplusz Kft.
Csongrád, 6640, Hungary
Petz Aladar Hospital
Győr, 9023, Hungary
Jósa Andras Hospital
Nyíregyháza, Hungary
Szte-Áok I
Szeged, 6720, Hungary
Balassa Janos Hospital
Szekszárd, 7100, Hungary
Zala Megyei Hospital
Zalaegerszeg, 8900, Hungary
Manipal Hospital,
Bangalore, Karantaka, 560 017, India
Health and Research Centre
Trivandrum, Kerala, 695 001, India
Diabetes Thyroid Hormone Research Institute Pvt Ltd.
Indore, Madhya Pradesh, 452001, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 500 082, India
M. V. Hosp for Diabetes P. Ltd. 4,
Chennai, 13, India
Medicity Hospital
Hyderabaad, 500 036, India
Nizam's institute of medical sciences,
Hyderabaad, 500 082, India
S. R. Kalla Memorial gastro and general hosp,
Jaipur, 302001, India
Christian Medical College,
Vellore, P. O. Box. No. 3., India
Maccabi Healthcare Services
Rishon LeZiyyon, 75650, Israel
Ziv Medical Center
Safed, 13100, 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, 5417, Latvia
Primary Health Centre of Jaunliepaja
Liepāja, 3401, Latvia
Private practice of endocrinology
Ogre, 5001, Latvia
Center of Endocrinology
Riga, 1002, Latvia
Riga Outpatient Clinic "Dziednieciba"
Riga, 1057, Latvia
Talsi Clinical Hospital
Talsi, 3201, Latvia
Endocrinology Department of Vidzemes Hospital
Valmiera, 4201, Latvia
JSC "Klinikiniai sprendimai"
Alytus, 63257, Lithuania
Kaunas District Hospital
Kaunas, 45130, Lithuania
Kaunas Silainiai Outpatient Clinic
Kaunas, 48259, Lithuania
Kaunas Medical University Hospital
Kaunas, 50009, Lithuania
Kaunas Dainavos Outpatient Clinic
Kaunas, 51270, Lithuania
Vilnius University Hospital Santariskiu Clinics
Vilnius, 08661, Lithuania
Private Endocrinology Clinic
Vilnius, 09112, Lithuania
Comité Bioetico para la Investigación Clínica S.C.
Mexico City, Durango, 03300, Mexico
Unidad Metabolica y Cardiovascular S.C.
Cuernavaca, Morelos, Mexico
Clínica Eugenio Sue
Mexico City, Polanco Chapultepec, 11550, Mexico
Clínica de Diabetes de la Secretaria de Salud de Durango
Durango, 34070, Mexico
Arke Estudios Clinicos S.A. de C.V.
Mexico City, 06700, Mexico
Flattum legesenter
Hønefoss, 3503, Norway
Randesund Helsesenter
Kristiansand, Norway
Sinsenklinikken
Oslo, 0580, Norway
Oslo Universitetssykehus
Oslo, Norway
Hinnastrekanten legekontor
Stavanger, 4020, 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, 85 822, Poland
NZOZ "Specjalista" Sp z o. o.
Kutno, 99 300, Poland
Oddzial Chorob Wewnetrznych
Mielec, 39 300, Poland
Poradnia Lekarza Rodzinnego
Poznan, 60 521, Poland
Poznański Ośrodek Medyczny "NOVAMED"
Poznan, 60 773, Poland
CMI Cardiologie "Dr. Pop Calin Florin"
Baia Mare, ap. 72, Romania
"C. I. Parhon" Endocrinology Institute
Bucharest, district 1, Romania
Medical Centre "Sanatatea Ta" SRL
Bucharest, district 2, Romania
Medical Practice SRL
Oradea, ap. 3, Romania
Anamed SRL
Oradea, ap. 5, Romania
Emergency County Hospital Ploiesti
Ploieşti, no. 100, Romania
Policlinica "Dr. Citu"
Timișoara, no. 27, Romania
MEDISPEKTRUM s.r.o,
Bratislava, Slovak Republic, 811 02, Slovakia
.Interna klinika, FN J.A. Reimana
Prešov, Slovak Republic, 081 81, Slovakia
Diabetologicka ambulancia,
Bratislava, Slovakia Republic, 81272, Slovakia
Diabetologicka ambulancia
Košice, Slovakia Republic, 040 01, Slovakia
Diabetologicka ambulancia,
Lučenec, Slovakia Republic, 984 01, Slovakia
NZZ Diabetologicka ambulancia
Nové Zámky, Slovakia Republic, 940 01, Slovakia
Diabetes centrum s.r.o
Trenčín, Slovakia Republic, 911 01, Slovakia
Diabetologicka ambulancia,
Žilina, Slovakia Republic, 010 01, Slovakia
Diametabol.s.r.o.,
Bratislava, 821 07, Slovakia
MUDr. Margita Kiripolska s.r.o
Považská Bystrica, 017 01, 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, Piso 4. Urb., Venezuela
Hospital Dr Miguel Perez Carreño. Servicio de Endocrinología. Sotano.
Caracas, Venezuela
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2009
First Posted
March 12, 2009
Study Start
February 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
December 29, 2020
Record last verified: 2013-01