Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00860288
Other study ID # CLAF237B2224
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date February 2009
Est. completion date March 2011

Study information

Verified date January 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 1988
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 78 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vildagliptin

Metformin

Placebo

Sitagliptin


Locations

Country Name City State
Argentina Clinica Medica Sin Internacion Buenos Aires
Argentina DIM Clinical Privada Buenos Aires
Argentina Grupo Medico Alem Buenos Aires
Argentina Instituto de Investigaciones Biomedicas Buenos Aires Santa Fe
Argentina Fundación de Estudios Farmacológicos y de Medicamentos Buenos Aires,
Argentina Grupo Colaborative Rosario Rosario Santa Fe
Austria Universitaetsklinik Graz medizinische Universitaetsklinik; Graz
Austria LKH Salzburg Landesklinik fuer Innere Medizin I Salzburg
Austria Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment Wien
Austria Millergasse 7 Wien
Austria Kindlergasse 4 Wiener Neustadt
Austria Kindlergasse 4 Wiener Neustadt
Belgium Private Practice Cardiology (Dr. Hollanders) De Pinte
Belgium Private Practice (Vernijns) Genk
Belgium Private Practice (Dr. De Meulemeester) Gozee
Belgium Huisartsenpraktijk Hygeia Hasselt
Belgium Private Practice (Dr. Jaak Mortelmans) Oostham
Belgium Private Practice Diabetology (Dr. Coucke) Sint-Gillis-Waas Sint-Niklaasstraat 117
Finland Lihavuustutkimusyksikkö Helsinki
Finland Mehiläinen Töölö Diabetesklinikka Helsinki
Finland Terveystalo Kuopio Kuopio
Finland Mehiläinen Lahti Lahti
Finland ODL Terveys Oy, Tutkimusyksikkö, Oulu
Finland Mehiläinen Riihimäki Riihimäki
Finland Terveystalo Tampereen työterveys Kalmar Tampere
Finland Myyrmäen terveysasema Vantaa
Germany Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger Augsburg
Germany Praxis Dr. Med. Kurt Rack Augsburg
Germany Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht Bad Kreuznach
Germany Klinische Forschung Berlin-Buch Berlin
Germany Praxis Dr. Med. Christina Bondke Berlin
Germany Praxis Dr. Med. Monika Kiper Berlin
Germany Praxis Dr. Med. Ulrike Venschott-Jordan Berlin
Germany Bibertal Klinik Bibertal
Germany Gemeinschaftspraxis Dr. med. Ali Boustani Diez
Germany Facharzt fuer Allgemeinmedizin Dorsten
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 Praxis Dr. Med. Daniela Freise Frankfurt
Germany Dial.-Med. Kerstin Steinbach Freital
Germany Gemeinschaftspraxis Fulda
Germany Praxis Dr. Med. Wolfgang Krause Grimma
Germany Krankenhaus Hagenow, Innere Medizin Hagenow
Germany Diabetes-Zentrum Wandsbek Hamburg
Germany MVZ-medicum Hamburg Hamburg
Germany Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle Herne
Germany Praxis Dr. Med. Helmut Anderten Hildesheim
Germany Praxis Dr. Med. Juergen Landschulze Kahla
Germany Praxis Dr. Med. Julia Chevts Karlsruhe
Germany Praxis Dr. Med. Hans-Helmut Seibert Kassel
Germany Praxis Dr. Med. Claudia Ulbrich Koeln
Germany Dres. Klein/Minnich Kuenzing
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. Altwicker, Dr. Kanis Reinfeld
Germany Praxis Dr. Med. Ulrich Aigner Rothenburg
Germany Praxis Dr. Med. Sabine Sedl Schoenberg
Germany Dres. Hiltensperger & Schaal Schrobenhausen
Germany Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer Schwabenheim
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 Sauter Wangen
Germany Praxis Dr. Med. Rudolf Matthias Remppis Weissenhorn
Germany Praxis Dr. Med. Peter Genthner Welzheim
Germany Gemeinschaftspraxis Dr. med. Reinhold Schneider und Christine Schneider Wetzlar
Greece Laiko General Hospital, Athens
Greece Lamia General Hospital Larisa
Greece Papageorgiou General Hospital Thessaloniki
Guatemala Clinica Dr. Erick Turcios Guatemala City
Guatemala Clinica Dr. Sergio Bran Guatemala City
Guatemala Clínica y Hospital Colón del Paciente Diabético Guatemala City
Guatemala Clínica y Hospital Colón del Paciente Diabético Guatemala City
Guatemala Endonutri S. A. Guatemala City
Guatemala Endonutri S.A Guatemala City
Hungary Károlyi Sándor Hospital Budapest
Hungary Szent Imre Hospital Budapest
Hungary Szent Margit Hospita Budapest
Hungary Konszenzusplusz Kft. Csongrád
Hungary Petz Aladar Hospital Gyor
Hungary Jósa Andras Hospital Nyíregyháza
Hungary Szte-Áok I Szeged
Hungary Balassa Janos Hospital Szekszárd
Hungary Zala Megyei Hospital Zalaegerszeg
India Manipal Hospital, Bangalore Karantaka
India M. V. Hosp for Diabetes P. Ltd. 4, Chennai
India Madras Diabetes Research Foundation Chennai Tamil Nadu
India Medicity Hospital Hyderabaad
India Nizam's institute of medical sciences, Hyderabaad
India Diabetes Thyroid Hormone Research Institute Pvt Ltd. Indore Madhya Pradesh
India S. R. Kalla Memorial gastro and general hosp, Jaipur
India Health and Research Centre Trivandrum Kerela
India Christian Medical College, Vellore
Israel Maccabi Healthcare Services Rishon Le Zion
Israel Ziv Medical Center Safed
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 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 S. Semplice Dip. di Endocrinologia e Diabetologia Dip. di Medicina Interna Milano
Italy U.O. Medicina II - Dip. Medicina Interna Milano
Italy Unità Cardio-Metabolica e Trials Clinici Dipartimento di Medicina Interna Milano
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
Korea, Republic of Eulji General Hospital Seoul
Korea, Republic of Kangbuk Samsung Medical center Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of The Catholic University of Korea Holy Family Hospital Seoul
Korea, Republic of Ajou university hospital Suwon
Latvia Daugavpils Regional Hospital Daugavpils
Latvia Primary Health Centre of Jaunliepaja Liepaja
Latvia Private practice of endocrinology Ogre
Latvia Center of Endocrinology Riga
Latvia Riga Outpatient Clinic "Dziednieciba" Riga
Latvia Talsi Clinical Hospital Talsi
Latvia Endocrinology Department of Vidzemes Hospital Valmiera
Lithuania JSC "Klinikiniai sprendimai" Alytus
Lithuania Kaunas Dainavos Outpatient Clinic Kaunas
Lithuania Kaunas District Hospital Kaunas
Lithuania Kaunas Medical University Hospital Kaunas
Lithuania Kaunas Silainiai Outpatient Clinic Kaunas
Lithuania Private Endocrinology Clinic Vilnius
Lithuania Vilnius University Hospital Santariskiu Clinics Vilnius
Mexico Unidad Metabolica y Cardiovascular S.C. Cuernavaca Morelos.
Mexico Clínica de Diabetes de la Secretaria de Salud de Durango Durango
Mexico Arke Estudios Clinicos S.A. de C.V. Mexico City
Mexico Clínica Eugenio Sue Mexico City Polanco Chapultepec
Mexico Comité Bioetico para la Investigación Clínica S.C. Mexico City Durango
Norway Flattum legesenter Hønefoss
Norway Randesund Helsesenter Kristiansand
Norway Oslo Universitetssykehus Oslo
Norway Sinsenklinikken Oslo
Norway Hinnastrekanten legekontor Stavanger
Norway Vennesla legesenter Vennesla
Peru 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
Poland Bydgoskie Centrum Diabetologii i Endokrynologii Bydgoszcz
Poland NZOZ "Specjalista" Sp z o. o. Kutno
Poland Oddzial Chorob Wewnetrznych Mielec
Poland Poradnia Lekarza Rodzinnego Poznan
Poland Poznanski Osrodek Medyczny "NOVAMED" Poznan
Romania CMI Cardiologie "Dr. Pop Calin Florin" Baia Mare
Romania "C. I. Parhon" Endocrinology Institute Bucharest
Romania Medical Centre "Sanatatea Ta" SRL Bucharest
Romania Anamed SRL Oradea
Romania Medical Practice SRL Oradea
Romania Emergency County Hospital Ploiesti Ploiesti
Romania Policlinica "Dr. Citu" Timisoara
Slovakia Diabetologicka ambulancia, Bratislava Slovakia Republic
Slovakia Diametabol.s.r.o., Bratislava
Slovakia MEDISPEKTRUM s.r.o, Bratislava Slovak Republic
Slovakia Diabetologicka ambulancia Kosice Slovakia Republic
Slovakia Diabetologicka ambulancia, Lucenec Slovakia Republic
Slovakia NZZ Diabetologicka ambulancia Nove Zamky Slovakia Republic
Slovakia MUDr. Margita Kiripolska s.r.o Povazska Bystrica
Slovakia .Interna klinika, FN J.A. Reimana Presov Slovak Republic
Slovakia Diabetes centrum s.r.o Trencin Slovakia Republic
Slovakia Diabetologicka ambulancia, Zilina Slovakia Republic
Venezuela Hospital Dr Miguel Perez Carreño. Servicio de Endocrinología. Sotano. Caracas
Venezuela Hospital Militar Dr Carlos Arvelo. Final Av. José Angel Lamas. Servicio de Endocrinología. Caracas.
Venezuela Ambulatorio Militar Tipo III Paramacay. Avenida Universidad. Sector Santa Ana. Naguanagua. Valencia Carabobo.

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Finland,  Germany,  Greece,  Guatemala,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Norway,  Peru,  Poland,  Romania,  Slovakia,  Venezuela, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2