search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vildagliptin
Metformin
Placebo
Sitagliptin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 Diabetes, vildagliptin

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Instituto de Investigaciones Biomedicas
  • Grupo Colaborative Rosario
  • Fundación de Estudios Farmacológicos y de Medicamentos
  • Grupo Medico Alem
  • DIM Clinical Privada
  • Clinica Medica Sin Internacion
  • Universitaetsklinik Graz medizinische Universitaetsklinik;
  • LKH Salzburg Landesklinik fuer Innere Medizin I
  • Kindlergasse 4
  • Kindlergasse 4
  • Millergasse 7
  • Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment
  • Private Practice Diabetology (Dr. Coucke)
  • Private Practice Cardiology (Dr. Hollanders)
  • Private Practice (Vernijns)
  • Private Practice (Dr. De Meulemeester)
  • Huisartsenpraktijk Hygeia
  • Private Practice (Dr. Jaak Mortelmans)
  • Lihavuustutkimusyksikkö
  • Mehiläinen Töölö Diabetesklinikka
  • Terveystalo Kuopio
  • Mehiläinen Lahti
  • ODL Terveys Oy, Tutkimusyksikkö,
  • Mehiläinen Riihimäki
  • Terveystalo Tampereen työterveys Kalmar
  • Myyrmäen terveysasema
  • Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger
  • Praxis Dr. Med. Kurt Rack
  • Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht
  • Klinische Forschung Berlin-Buch
  • Praxis Dr. Med. Ulrike Venschott-Jordan
  • Praxis Dr. Med. Monika Kiper
  • Praxis Dr. Med. Christina Bondke
  • Bibertal Klinik
  • Gemeinschaftspraxis Dr. med. Ali Boustani
  • Facharzt fuer Allgemeinmedizin
  • Praxis Dr. Med. Anwar Ansari
  • Hausaerzte am Stern Dr. Med. Blume / Dr. Med. Garanin
  • Praxis Dr. Med. Roland Kutzke
  • Praxis Dr. Med. Thorsten Rau
  • Praxis Dr. Med. Joerg Luedemann / Facharzt fuer Innere Medizin - Diabetologie
  • Praxis Dr. Med. Daniela Freise
  • Dial.-Med. Kerstin Steinbach
  • Gemeinschaftspraxis
  • Praxis Dr. Med. Wolfgang Krause
  • Krankenhaus Hagenow, Innere Medizin
  • MVZ-medicum Hamburg
  • Diabetes-Zentrum Wandsbek
  • Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle
  • Praxis Dr. Med. Helmut Anderten
  • Praxis Dr. Med. Juergen Landschulze
  • Praxis Dr. Med. Julia Chevts
  • Praxis Dr. Med. Hans-Helmut Seibert
  • Praxis Dr. Med. Claudia Ulbrich
  • Dres. Klein/Minnich
  • Praxis Dr. Med. Birgit Hoene
  • Pro Scientia med
  • Diabetes Schwerpunktpraxis
  • Praxis Dres. Prohaska / Lindner
  • Praxis Dr. Med. Claus-Michael Grimm
  • Praxis Dr. Fischer & Dr. Keuthage
  • Gemeinschaftspraxis Dr. Uwe Böckmann/Dr. med. Maren Molkewehrum
  • Praxis Dr. Med. Joachim Etter
  • IkFE Studiencenter Potsdam GMBH i.G.
  • Diabetes Center Quakenbrueck
  • Praxis Dr. Altwicker, Dr. Kanis
  • Praxis Dr. Med. Ulrich Aigner
  • Praxis Dr. Med. Sabine Sedl
  • Dres. Hiltensperger & Schaal
  • Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer
  • Praxis Dr. Med. Ottmar Herfert
  • Praxis Dr. Med. Doru Popa
  • Gemeinschaftspraxis Gerhard Steinmaier und Dr. Med. Werner Bauer
  • Gemeinschaftspraxis Sauter
  • Praxis Dr. Med. Rudolf Matthias Remppis
  • Praxis Dr. Med. Peter Genthner
  • Gemeinschaftspraxis Dr. med. Reinhold Schneider und Christine Schneider
  • Laiko General Hospital,
  • Lamia General Hospital
  • Papageorgiou General Hospital
  • Clínica y Hospital Colón del Paciente Diabético
  • Endonutri S.A
  • Clínica y Hospital Colón del Paciente Diabético
  • Clinica Dr. Erick Turcios
  • Endonutri S. A.
  • Clinica Dr. Sergio Bran
  • Szent Margit Hospita
  • Károlyi Sándor Hospital
  • Szent Imre Hospital
  • Konszenzusplusz Kft.
  • Petz Aladar Hospital
  • Jósa Andras Hospital
  • Szte-Áok I
  • Balassa Janos Hospital
  • Zala Megyei Hospital
  • Manipal Hospital,
  • Health and Research Centre
  • Diabetes Thyroid Hormone Research Institute Pvt Ltd.
  • Madras Diabetes Research Foundation
  • M. V. Hosp for Diabetes P. Ltd. 4,
  • Medicity Hospital
  • Nizam's institute of medical sciences,
  • S. R. Kalla Memorial gastro and general hosp,
  • Christian Medical College,
  • Maccabi Healthcare Services
  • Ziv Medical Center
  • U.O.C. di Diabetologia e Malattie Metaboliche
  • U.S.C. di Endocrinologia (Ingresso 13 - piano 2) Dip. di Medicina
  • U.O.C. Diabetologia Endocrinologia Dip. Medico
  • U.O. Medicina Generale
  • I Divisione Medicina
  • U.O. Malattie Metaboliche e Diabetologia
  • U.O.C. di Medicina d'Urgenza e Pronto Soccorso
  • Servizio Diabetologia, SOD Cardiologia Geriatrica - D.A.I. del Cuore e dei Vasi
  • Centro Diabetologico Malattie Metaboliche
  • Divisione Malattie Metaboliche e Diabetologia
  • S. Semplice Dip. di Endocrinologia e Diabetologia Dip. di Medicina Interna
  • U.O. Medicina II - Dip. Medicina Interna
  • Unità Cardio-Metabolica e Trials Clinici Dipartimento di Medicina Interna
  • U.O. Diabetologia
  • Centro per l'Aterosclerosi Dip. di Medicina Interna
  • U.O. Endocrinologia e Diabetologia
  • U.O.C. di Diabetologia c/o AUSL ROMA B - Sede Territoriale
  • U.O.C. di Medicina Interna B - BMI02 Dip. Scienze Cliniche - II Clinica Medica
  • S. S. di Diabetologia Dip. Med. Interna e Malattie Metaboliche
  • S.C. Prevenzione-Riabilitazione Cardiologica presso ex-Dispensario
  • Eulji General Hospital
  • Kangbuk Samsung Medical center
  • Korea University Guro Hospital
  • The Catholic University of Korea Holy Family Hospital
  • Ajou university hospital
  • Daugavpils Regional Hospital
  • Primary Health Centre of Jaunliepaja
  • Private practice of endocrinology
  • Center of Endocrinology
  • Riga Outpatient Clinic "Dziednieciba"
  • Talsi Clinical Hospital
  • Endocrinology Department of Vidzemes Hospital
  • JSC "Klinikiniai sprendimai"
  • Kaunas District Hospital
  • Kaunas Silainiai Outpatient Clinic
  • Kaunas Medical University Hospital
  • Kaunas Dainavos Outpatient Clinic
  • Vilnius University Hospital Santariskiu Clinics
  • Private Endocrinology Clinic
  • Comité Bioetico para la Investigación Clínica S.C.
  • Unidad Metabolica y Cardiovascular S.C.
  • Clínica Eugenio Sue
  • Clínica de Diabetes de la Secretaria de Salud de Durango
  • Arke Estudios Clinicos S.A. de C.V.
  • Flattum legesenter
  • Randesund Helsesenter
  • Sinsenklinikken
  • Oslo Universitetssykehus
  • Hinnastrekanten legekontor
  • Vennesla legesenter
  • Clinica San Miguel
  • Clinica Geriatrica Militar
  • Clinica San Borja
  • Clinica Senor de los Milagros
  • Hospital Nacional Cayetano Heredia
  • Hospital Nacional Guillermo Almenara Irigoyen
  • Bydgoskie Centrum Diabetologii i Endokrynologii
  • NZOZ "Specjalista" Sp z o. o.
  • Oddzial Chorob Wewnetrznych
  • Poradnia Lekarza Rodzinnego
  • Poznański Ośrodek Medyczny "NOVAMED"
  • CMI Cardiologie "Dr. Pop Calin Florin"
  • "C. I. Parhon" Endocrinology Institute
  • Medical Centre "Sanatatea Ta" SRL
  • Medical Practice SRL
  • Anamed SRL
  • Emergency County Hospital Ploiesti
  • Policlinica "Dr. Citu"
  • MEDISPEKTRUM s.r.o,
  • .Interna klinika, FN J.A. Reimana
  • Diabetologicka ambulancia,
  • Diabetologicka ambulancia
  • Diabetologicka ambulancia,
  • NZZ Diabetologicka ambulancia
  • Diabetes centrum s.r.o
  • Diabetologicka ambulancia,
  • Diametabol.s.r.o.,
  • MUDr. Margita Kiripolska s.r.o
  • Ambulatorio Militar Tipo III Paramacay. Avenida Universidad. Sector Santa Ana. Naguanagua.
  • Hospital Militar Dr Carlos Arvelo. Final Av. José Angel Lamas. Servicio de Endocrinología.
  • Hospital Dr Miguel Perez Carreño. Servicio de Endocrinología. Sotano.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Vildagliptin Dose 1

Vildagliptin Dose 2

Placebo

Sitagliptin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 10, 2009
Last Updated
December 17, 2020
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00860288
Brief Title
Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 Diabetes, vildagliptin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1988 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin Dose 1
Arm Type
Experimental
Arm Title
Vildagliptin Dose 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Sitagliptin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Primary Outcome Measure Information:
Title
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
24 weeks
Title
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.
Time Frame
24 weeks
Title
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.
Time Frame
24 weeks
Title
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.
Time Frame
24 weeks
Title
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.
Time Frame
76 weeks
Title
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.
Time Frame
24 weeks
Title
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.
Time Frame
76 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Instituto de Investigaciones Biomedicas
City
Buenos Aires
State/Province
Santa Fe
ZIP/Postal Code
3000FNF
Country
Argentina
Facility Name
Grupo Colaborative Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002OJP
Country
Argentina
Facility Name
Fundación de Estudios Farmacológicos y de Medicamentos
City
Buenos Aires,
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
Grupo Medico Alem
City
Buenos Aires
ZIP/Postal Code
B1642DCD
Country
Argentina
Facility Name
DIM Clinical Privada
City
Buenos Aires
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
Clinica Medica Sin Internacion
City
Buenos Aires
ZIP/Postal Code
B1824KAJ
Country
Argentina
Facility Name
Universitaetsklinik Graz medizinische Universitaetsklinik;
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
LKH Salzburg Landesklinik fuer Innere Medizin I
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Kindlergasse 4
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
Facility Name
Kindlergasse 4
City
Wiener Neustadt
Country
Austria
Facility Name
Millergasse 7
City
Wien
ZIP/Postal Code
1060
Country
Austria
Facility Name
Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Private Practice Diabetology (Dr. Coucke)
City
Sint-Gillis-Waas
State/Province
Sint-Niklaasstraat 117
ZIP/Postal Code
9170
Country
Belgium
Facility Name
Private Practice Cardiology (Dr. Hollanders)
City
De Pinte
ZIP/Postal Code
9840
Country
Belgium
Facility Name
Private Practice (Vernijns)
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Private Practice (Dr. De Meulemeester)
City
Gozee
ZIP/Postal Code
6534
Country
Belgium
Facility Name
Huisartsenpraktijk Hygeia
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Private Practice (Dr. Jaak Mortelmans)
City
Oostham
ZIP/Postal Code
3945
Country
Belgium
Facility Name
Lihavuustutkimusyksikkö
City
Helsinki
ZIP/Postal Code
2 A 2 00270
Country
Finland
Facility Name
Mehiläinen Töölö Diabetesklinikka
City
Helsinki
ZIP/Postal Code
47 A 00260
Country
Finland
Facility Name
Terveystalo Kuopio
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Mehiläinen Lahti
City
Lahti
ZIP/Postal Code
6 C 15110
Country
Finland
Facility Name
ODL Terveys Oy, Tutkimusyksikkö,
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Mehiläinen Riihimäki
City
Riihimäki
ZIP/Postal Code
11130
Country
Finland
Facility Name
Terveystalo Tampereen työterveys Kalmar
City
Tampere
ZIP/Postal Code
33900
Country
Finland
Facility Name
Myyrmäen terveysasema
City
Vantaa
ZIP/Postal Code
01600
Country
Finland
Facility Name
Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Praxis Dr. Med. Kurt Rack
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht
City
Bad Kreuznach
ZIP/Postal Code
55545
Country
Germany
Facility Name
Klinische Forschung Berlin-Buch
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Praxis Dr. Med. Ulrike Venschott-Jordan
City
Berlin
ZIP/Postal Code
12247
Country
Germany
Facility Name
Praxis Dr. Med. Monika Kiper
City
Berlin
ZIP/Postal Code
12347
Country
Germany
Facility Name
Praxis Dr. Med. Christina Bondke
City
Berlin
ZIP/Postal Code
13189
Country
Germany
Facility Name
Bibertal Klinik
City
Bibertal
ZIP/Postal Code
89346
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. Ali Boustani
City
Diez
ZIP/Postal Code
65582
Country
Germany
Facility Name
Facharzt fuer Allgemeinmedizin
City
Dorsten
ZIP/Postal Code
46282
Country
Germany
Facility Name
Praxis Dr. Med. Anwar Ansari
City
Einbeck
ZIP/Postal Code
37574
Country
Germany
Facility Name
Hausaerzte am Stern Dr. Med. Blume / Dr. Med. Garanin
City
Essen
ZIP/Postal Code
45130
Country
Germany
Facility Name
Praxis Dr. Med. Roland Kutzke
City
Essen
ZIP/Postal Code
45144
Country
Germany
Facility Name
Praxis Dr. Med. Thorsten Rau
City
Essen
ZIP/Postal Code
45276
Country
Germany
Facility Name
Praxis Dr. Med. Joerg Luedemann / Facharzt fuer Innere Medizin - Diabetologie
City
Falkensee
ZIP/Postal Code
14612
Country
Germany
Facility Name
Praxis Dr. Med. Daniela Freise
City
Frankfurt
ZIP/Postal Code
60599
Country
Germany
Facility Name
Dial.-Med. Kerstin Steinbach
City
Freital
ZIP/Postal Code
01705
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Fulda
ZIP/Postal Code
36037
Country
Germany
Facility Name
Praxis Dr. Med. Wolfgang Krause
City
Grimma
ZIP/Postal Code
04668
Country
Germany
Facility Name
Krankenhaus Hagenow, Innere Medizin
City
Hagenow
ZIP/Postal Code
19230
Country
Germany
Facility Name
MVZ-medicum Hamburg
City
Hamburg
ZIP/Postal Code
20097
Country
Germany
Facility Name
Diabetes-Zentrum Wandsbek
City
Hamburg
ZIP/Postal Code
22041
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle
City
Herne
ZIP/Postal Code
44653
Country
Germany
Facility Name
Praxis Dr. Med. Helmut Anderten
City
Hildesheim
ZIP/Postal Code
31139
Country
Germany
Facility Name
Praxis Dr. Med. Juergen Landschulze
City
Kahla
ZIP/Postal Code
07768
Country
Germany
Facility Name
Praxis Dr. Med. Julia Chevts
City
Karlsruhe
ZIP/Postal Code
76199
Country
Germany
Facility Name
Praxis Dr. Med. Hans-Helmut Seibert
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Praxis Dr. Med. Claudia Ulbrich
City
Koeln
ZIP/Postal Code
50823
Country
Germany
Facility Name
Dres. Klein/Minnich
City
Kuenzing
ZIP/Postal Code
94550
Country
Germany
Facility Name
Praxis Dr. Med. Birgit Hoene
City
Leipzig
Country
Germany
Facility Name
Pro Scientia med
City
Luebeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Diabetes Schwerpunktpraxis
City
Meissen
ZIP/Postal Code
01662
Country
Germany
Facility Name
Praxis Dres. Prohaska / Lindner
City
Muehldorf
ZIP/Postal Code
84453
Country
Germany
Facility Name
Praxis Dr. Med. Claus-Michael Grimm
City
Muenchen
ZIP/Postal Code
81373
Country
Germany
Facility Name
Praxis Dr. Fischer & Dr. Keuthage
City
Muenster
ZIP/Postal Code
48153
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Uwe Böckmann/Dr. med. Maren Molkewehrum
City
Neumunster
ZIP/Postal Code
24534
Country
Germany
Facility Name
Praxis Dr. Med. Joachim Etter
City
Oberhausen
ZIP/Postal Code
46049
Country
Germany
Facility Name
IkFE Studiencenter Potsdam GMBH i.G.
City
Potsdam
ZIP/Postal Code
14469
Country
Germany
Facility Name
Diabetes Center Quakenbrueck
City
Quakenbrueck
ZIP/Postal Code
49610
Country
Germany
Facility Name
Praxis Dr. Altwicker, Dr. Kanis
City
Reinfeld
ZIP/Postal Code
23858
Country
Germany
Facility Name
Praxis Dr. Med. Ulrich Aigner
City
Rothenburg
Country
Germany
Facility Name
Praxis Dr. Med. Sabine Sedl
City
Schoenberg
ZIP/Postal Code
23923
Country
Germany
Facility Name
Dres. Hiltensperger & Schaal
City
Schrobenhausen
ZIP/Postal Code
86529
Country
Germany
Facility Name
Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer
City
Schwabenheim
ZIP/Postal Code
55270
Country
Germany
Facility Name
Praxis Dr. Med. Ottmar Herfert
City
Stuttgart
ZIP/Postal Code
70469
Country
Germany
Facility Name
Praxis Dr. Med. Doru Popa
City
Veitsbronn
ZIP/Postal Code
90587
Country
Germany
Facility Name
Gemeinschaftspraxis Gerhard Steinmaier und Dr. Med. Werner Bauer
City
Viernheim
ZIP/Postal Code
68519
Country
Germany
Facility Name
Gemeinschaftspraxis Sauter
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Praxis Dr. Med. Rudolf Matthias Remppis
City
Weissenhorn
ZIP/Postal Code
89264
Country
Germany
Facility Name
Praxis Dr. Med. Peter Genthner
City
Welzheim
ZIP/Postal Code
73642
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. Reinhold Schneider und Christine Schneider
City
Wetzlar
ZIP/Postal Code
35584
Country
Germany
Facility Name
Laiko General Hospital,
City
Athens
ZIP/Postal Code
GR11527
Country
Greece
Facility Name
Lamia General Hospital
City
Larisa
ZIP/Postal Code
GR 35100
Country
Greece
Facility Name
Papageorgiou General Hospital
City
Thessaloniki
ZIP/Postal Code
GR56403
Country
Greece
Facility Name
Clínica y Hospital Colón del Paciente Diabético
City
Guatemala City
ZIP/Postal Code
01001
Country
Guatemala
Facility Name
Endonutri S.A
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Clínica y Hospital Colón del Paciente Diabético
City
Guatemala City
ZIP/Postal Code
11-49
Country
Guatemala
Facility Name
Clinica Dr. Erick Turcios
City
Guatemala City
ZIP/Postal Code
Oficina 1114
Country
Guatemala
Facility Name
Endonutri S. A.
City
Guatemala City
ZIP/Postal Code
Oficina 909
Country
Guatemala
Facility Name
Clinica Dr. Sergio Bran
City
Guatemala City
Country
Guatemala
Facility Name
Szent Margit Hospita
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Károlyi Sándor Hospital
City
Budapest
ZIP/Postal Code
1041
Country
Hungary
Facility Name
Szent Imre Hospital
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Konszenzusplusz Kft.
City
Csongrád
ZIP/Postal Code
6640
Country
Hungary
Facility Name
Petz Aladar Hospital
City
Győr
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Jósa Andras Hospital
City
Nyíregyháza
Country
Hungary
Facility Name
Szte-Áok I
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Balassa Janos Hospital
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Zala Megyei Hospital
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Manipal Hospital,
City
Bangalore
State/Province
Karantaka
ZIP/Postal Code
560 017
Country
India
Facility Name
Health and Research Centre
City
Trivandrum
State/Province
Kerela
ZIP/Postal Code
695 001
Country
India
Facility Name
Diabetes Thyroid Hormone Research Institute Pvt Ltd.
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452001
Country
India
Facility Name
Madras Diabetes Research Foundation
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
500 082
Country
India
Facility Name
M. V. Hosp for Diabetes P. Ltd. 4,
City
Chennai
ZIP/Postal Code
13
Country
India
Facility Name
Medicity Hospital
City
Hyderabaad
ZIP/Postal Code
500 036
Country
India
Facility Name
Nizam's institute of medical sciences,
City
Hyderabaad
ZIP/Postal Code
500 082
Country
India
Facility Name
S. R. Kalla Memorial gastro and general hosp,
City
Jaipur
ZIP/Postal Code
302001
Country
India
Facility Name
Christian Medical College,
City
Vellore
ZIP/Postal Code
P. O. Box. No. 3.
Country
India
Facility Name
Maccabi Healthcare Services
City
Rishon Le Zion
ZIP/Postal Code
75650
Country
Israel
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
U.O.C. di Diabetologia e Malattie Metaboliche
City
Arenzano
Country
Italy
Facility Name
U.S.C. di Endocrinologia (Ingresso 13 - piano 2) Dip. di Medicina
City
Bergamo
Country
Italy
Facility Name
U.O.C. Diabetologia Endocrinologia Dip. Medico
City
Campobasso
Country
Italy
Facility Name
U.O. Medicina Generale
City
Casorate Primo
Country
Italy
Facility Name
I Divisione Medicina
City
Catania
Country
Italy
Facility Name
U.O. Malattie Metaboliche e Diabetologia
City
Chieri
Country
Italy
Facility Name
U.O.C. di Medicina d'Urgenza e Pronto Soccorso
City
Cosenza
Country
Italy
Facility Name
Servizio Diabetologia, SOD Cardiologia Geriatrica - D.A.I. del Cuore e dei Vasi
City
Firenze
Country
Italy
Facility Name
Centro Diabetologico Malattie Metaboliche
City
Mercato San Severino
Country
Italy
Facility Name
Divisione Malattie Metaboliche e Diabetologia
City
Milano
Country
Italy
Facility Name
S. Semplice Dip. di Endocrinologia e Diabetologia Dip. di Medicina Interna
City
Milano
Country
Italy
Facility Name
U.O. Medicina II - Dip. Medicina Interna
City
Milano
Country
Italy
Facility Name
Unità Cardio-Metabolica e Trials Clinici Dipartimento di Medicina Interna
City
Milano
Country
Italy
Facility Name
U.O. Diabetologia
City
Olbia
Country
Italy
Facility Name
Centro per l'Aterosclerosi Dip. di Medicina Interna
City
Roma
Country
Italy
Facility Name
U.O. Endocrinologia e Diabetologia
City
Roma
Country
Italy
Facility Name
U.O.C. di Diabetologia c/o AUSL ROMA B - Sede Territoriale
City
Roma
Country
Italy
Facility Name
U.O.C. di Medicina Interna B - BMI02 Dip. Scienze Cliniche - II Clinica Medica
City
Roma
Country
Italy
Facility Name
S. S. di Diabetologia Dip. Med. Interna e Malattie Metaboliche
City
Siena
Country
Italy
Facility Name
S.C. Prevenzione-Riabilitazione Cardiologica presso ex-Dispensario
City
Vibo Valentia
Country
Italy
Facility Name
Eulji General Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Medical center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Holy Family Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou university hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
Facility Name
Primary Health Centre of Jaunliepaja
City
Liepaja
ZIP/Postal Code
3401
Country
Latvia
Facility Name
Private practice of endocrinology
City
Ogre
ZIP/Postal Code
5001
Country
Latvia
Facility Name
Center of Endocrinology
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Riga Outpatient Clinic "Dziednieciba"
City
Riga
ZIP/Postal Code
1057
Country
Latvia
Facility Name
Talsi Clinical Hospital
City
Talsi
ZIP/Postal Code
3201
Country
Latvia
Facility Name
Endocrinology Department of Vidzemes Hospital
City
Valmiera
ZIP/Postal Code
4201
Country
Latvia
Facility Name
JSC "Klinikiniai sprendimai"
City
Alytus
ZIP/Postal Code
63257
Country
Lithuania
Facility Name
Kaunas District Hospital
City
Kaunas
ZIP/Postal Code
45130
Country
Lithuania
Facility Name
Kaunas Silainiai Outpatient Clinic
City
Kaunas
ZIP/Postal Code
48259
Country
Lithuania
Facility Name
Kaunas Medical University Hospital
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Kaunas Dainavos Outpatient Clinic
City
Kaunas
ZIP/Postal Code
51270
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinics
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Private Endocrinology Clinic
City
Vilnius
ZIP/Postal Code
09112
Country
Lithuania
Facility Name
Comité Bioetico para la Investigación Clínica S.C.
City
Mexico City
State/Province
Durango
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Unidad Metabolica y Cardiovascular S.C.
City
Cuernavaca
State/Province
Morelos.
Country
Mexico
Facility Name
Clínica Eugenio Sue
City
Mexico City
State/Province
Polanco Chapultepec
ZIP/Postal Code
11550
Country
Mexico
Facility Name
Clínica de Diabetes de la Secretaria de Salud de Durango
City
Durango
ZIP/Postal Code
34070
Country
Mexico
Facility Name
Arke Estudios Clinicos S.A. de C.V.
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Flattum legesenter
City
Hønefoss
ZIP/Postal Code
3503
Country
Norway
Facility Name
Randesund Helsesenter
City
Kristiansand
Country
Norway
Facility Name
Sinsenklinikken
City
Oslo
ZIP/Postal Code
0580
Country
Norway
Facility Name
Oslo Universitetssykehus
City
Oslo
Country
Norway
Facility Name
Hinnastrekanten legekontor
City
Stavanger
ZIP/Postal Code
4020
Country
Norway
Facility Name
Vennesla legesenter
City
Vennesla
Country
Norway
Facility Name
Clinica San Miguel
City
Arequipa
Country
Peru
Facility Name
Clinica Geriatrica Militar
City
Lima
Country
Peru
Facility Name
Clinica San Borja
City
LIma
Country
Peru
Facility Name
Clinica Senor de los Milagros
City
Lima
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia
City
Lima
Country
Peru
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen
City
Lima
Country
Peru
Facility Name
Bydgoskie Centrum Diabetologii i Endokrynologii
City
Bydgoszcz
ZIP/Postal Code
85 822
Country
Poland
Facility Name
NZOZ "Specjalista" Sp z o. o.
City
Kutno
ZIP/Postal Code
99 300
Country
Poland
Facility Name
Oddzial Chorob Wewnetrznych
City
Mielec
ZIP/Postal Code
39 300
Country
Poland
Facility Name
Poradnia Lekarza Rodzinnego
City
Poznan
ZIP/Postal Code
60 521
Country
Poland
Facility Name
Poznański Ośrodek Medyczny "NOVAMED"
City
Poznań
ZIP/Postal Code
60 773
Country
Poland
Facility Name
CMI Cardiologie "Dr. Pop Calin Florin"
City
Baia Mare
ZIP/Postal Code
ap. 72
Country
Romania
Facility Name
"C. I. Parhon" Endocrinology Institute
City
Bucharest
ZIP/Postal Code
district 1
Country
Romania
Facility Name
Medical Centre "Sanatatea Ta" SRL
City
Bucharest
ZIP/Postal Code
district 2
Country
Romania
Facility Name
Medical Practice SRL
City
Oradea
ZIP/Postal Code
ap. 3
Country
Romania
Facility Name
Anamed SRL
City
Oradea
ZIP/Postal Code
ap. 5
Country
Romania
Facility Name
Emergency County Hospital Ploiesti
City
Ploiesti
ZIP/Postal Code
no. 100
Country
Romania
Facility Name
Policlinica "Dr. Citu"
City
Timisoara
ZIP/Postal Code
no. 27
Country
Romania
Facility Name
MEDISPEKTRUM s.r.o,
City
Bratislava
State/Province
Slovak Republic
ZIP/Postal Code
811 02
Country
Slovakia
Facility Name
.Interna klinika, FN J.A. Reimana
City
Presov
State/Province
Slovak Republic
ZIP/Postal Code
081 81
Country
Slovakia
Facility Name
Diabetologicka ambulancia,
City
Bratislava
State/Province
Slovakia Republic
ZIP/Postal Code
81272
Country
Slovakia
Facility Name
Diabetologicka ambulancia
City
Kosice
State/Province
Slovakia Republic
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Diabetologicka ambulancia,
City
Lucenec
State/Province
Slovakia Republic
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
NZZ Diabetologicka ambulancia
City
Nove Zamky
State/Province
Slovakia Republic
ZIP/Postal Code
940 01
Country
Slovakia
Facility Name
Diabetes centrum s.r.o
City
Trencin
State/Province
Slovakia Republic
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
Diabetologicka ambulancia,
City
Zilina
State/Province
Slovakia Republic
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
Diametabol.s.r.o.,
City
Bratislava
ZIP/Postal Code
821 07
Country
Slovakia
Facility Name
MUDr. Margita Kiripolska s.r.o
City
Povazska Bystrica
ZIP/Postal Code
017 01
Country
Slovakia
Facility Name
Ambulatorio Militar Tipo III Paramacay. Avenida Universidad. Sector Santa Ana. Naguanagua.
City
Valencia
State/Province
Carabobo.
Country
Venezuela
Facility Name
Hospital Militar Dr Carlos Arvelo. Final Av. José Angel Lamas. Servicio de Endocrinología.
City
Caracas.
ZIP/Postal Code
Piso 4. Urb.
Country
Venezuela
Facility Name
Hospital Dr Miguel Perez Carreño. Servicio de Endocrinología. Sotano.
City
Caracas
Country
Venezuela

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5663
Description
Results for CLAF237B2224 from the Novartis Clinical Trials website

Learn more about this trial

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

We'll reach out to this number within 24 hrs