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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: Metformin; Drug: Sitagliptin; Drug: Vildagliptin

• Study Type: Interventional
• Enrollment (Actual): 1988
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Drug: Metformin
ACTIVE_COMPARATOR: Sitagliptin	Drug: Metformin; Drug: Sitagliptin
EXPERIMENTAL: Vildagliptin Dose 1	Drug: Metformin; Drug: Vildagliptin
EXPERIMENTAL: Vildagliptin Dose 2	Drug: Metformin; Drug: Vildagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CLAF237B2224 from the Novartis Clinical Trials website

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: March 10, 2009
• First Submitted That Met QC Criteria: March 11, 2009
• First Posted (ESTIMATE): March 12, 2009

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; vildagliptin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Sitagliptin Phosphate; Vildagliptin
• Other Study ID Numbers: CLAF237B2224