Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | 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 |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Vildagliptin Drug: Metformin Drug: Placebo Drug: Sitagliptin |
| Phase | Phase 2/Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Responsible Party | Novartis |
| ClinicalTrials.gov Identifier | NCT00860288 |
| First Received | March 10, 2009 |
| Last Updated | January 3, 2013 |
| Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 10, 2009 |
|---|---|
| Last Updated Date | January 3, 2013 |
| Start Date | February 2009 |
| Estimated Primary Completion Date | March 2011 |
| Current 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 [Time Frame: 24 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes |
|---|---|
| Official Title | Not Provided |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 2/Phase 3 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Vildagliptin Drug: Metformin Drug: Placebo Drug: Sitagliptin |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 1988 |
| Estimated Completion Date | March 2011 |
| Estimated Primary Completion Date | March 2011 |
| 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) |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Argentina, Austria, Belgium, Finland, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Norway, Peru, Poland, Romania, Slovakia, Venezuela |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00860288 |
|---|---|
| Other Study ID Numbers | CLAF237B2224 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Novartis |
| Study Sponsor | Novartis Pharmaceuticals |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | January 2013 |
Locations[ + expand ][ + ]
| Instituto de Investigaciones Biomedicas | Buenos Aires, Santa Fe, Argentina, 3000FNF |
|---|---|
| Grupo Colaborative Rosario | Rosario, Santa Fe, Argentina, S2002OJP |
| Grupo Medico Alem | Buenos Aires, Argentina, B1642DCD |
| Clinica Medica Sin Internacion | Buenos Aires, Argentina, B1824KAJ |
| DIM Clinical Privada | Buenos Aires, Argentina, B1704ETD |
| Fundación de Estudios Farmacológicos y de Medicamentos | Buenos Aires,, Argentina, C1027AAP |
| Universitaetsklinik Graz medizinische Universitaetsklinik; | Graz, Austria, 8036 |
| LKH Salzburg Landesklinik fuer Innere Medizin I | Salzburg, Austria, 5020 |
| Millergasse 7 | Wien, Austria, 1060 |
| Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment | Wien, Austria, 1140 |
| Kindlergasse 4 | Wiener Neustadt, Austria |
| Kindlergasse 4 | Wiener Neustadt, Austria, 2700 |
| Private Practice Diabetology (Dr. Coucke) | Sint-Gillis-Waas, Sint-Niklaasstraat 117, Belgium, 9170 |
| Private Practice Cardiology (Dr. Hollanders) | De Pinte, Belgium, 9840 |
| Private Practice (Vernijns) | Genk, Belgium, 3600 |
| Private Practice (Dr. De Meulemeester) | Gozee, Belgium, 6534 |
| Huisartsenpraktijk Hygeia | Hasselt, Belgium, 3500 |
| Private Practice (Dr. Jaak Mortelmans) | Oostham, Belgium, 3945 |
| Mehiläinen Töölö Diabetesklinikka | Helsinki, Finland, 47 A 00260 |
| Lihavuustutkimusyksikkö | Helsinki, Finland, 2 A 2 00270 |
| Terveystalo Kuopio | Kuopio, Finland, 70100 |
| Mehiläinen Lahti | Lahti, Finland, 6 C 15110 |
| ODL Terveys Oy, Tutkimusyksikkö, | Oulu, Finland, 90100 |
| Mehiläinen Riihimäki | Riihimäki, Finland, 11130 |
| Terveystalo Tampereen työterveys Kalmar | Tampere, Finland, 33900 |
| Myyrmäen terveysasema | Vantaa, Finland, 01600 |
| Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger | Augsburg, Germany, 86150 |
| Praxis Dr. Med. Kurt Rack | Augsburg, Germany, 86150 |
| Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht | Bad Kreuznach, Germany, 55545 |
| Klinische Forschung Berlin-Buch | Berlin, Germany, 10117 |
| Praxis Dr. Med. Christina Bondke | Berlin, Germany, 13189 |
| Praxis Dr. Med. Ulrike Venschott-Jordan | Berlin, Germany, 12247 |
| Praxis Dr. Med. Monika Kiper | Berlin, Germany, 12347 |
| Bibertal Klinik | Bibertal, Germany, 89346 |
| Gemeinschaftspraxis Dr. med. Ali Boustani | Diez, Germany, 65582 |
| Facharzt fuer Allgemeinmedizin | Dorsten, Germany, 46282 |
| Praxis Dr. Med. Anwar Ansari | Einbeck, Germany, 37574 |
| Hausaerzte am Stern Dr. Med. Blume / Dr. Med. Garanin | Essen, Germany, 45130 |
| Praxis Dr. Med. Roland Kutzke | Essen, Germany, 45144 |
| Praxis Dr. Med. Thorsten Rau | Essen, Germany, 45276 |
| Praxis Dr. Med. Joerg Luedemann / Facharzt fuer Innere Medizin - Diabetologie | Falkensee, Germany, 14612 |
| Praxis Dr. Med. Daniela Freise | Frankfurt, Germany, 60599 |
| Dial.-Med. Kerstin Steinbach | Freital, Germany, 01705 |
| Gemeinschaftspraxis | Fulda, Germany, 36037 |
| Praxis Dr. Med. Wolfgang Krause | Grimma, Germany, 04668 |
| Krankenhaus Hagenow, Innere Medizin | Hagenow, Germany, 19230 |
| Diabetes-Zentrum Wandsbek | Hamburg, Germany, 22041 |
| MVZ-medicum Hamburg | Hamburg, Germany, 20097 |
| Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle | Herne, Germany, 44653 |
| Praxis Dr. Med. Helmut Anderten | Hildesheim, Germany, 31139 |
| Praxis Dr. Med. Juergen Landschulze | Kahla, Germany, 07768 |
| Praxis Dr. Med. Julia Chevts | Karlsruhe, Germany, 76199 |
| Praxis Dr. Med. Hans-Helmut Seibert | Kassel, Germany, 34125 |
| Praxis Dr. Med. Claudia Ulbrich | Koeln, Germany, 50823 |
| Dres. Klein/Minnich | Kuenzing, Germany, 94550 |
| Praxis Dr. Med. Birgit Hoene | Leipzig, Germany |
| Pro Scientia med | Luebeck, Germany, 23562 |
| Diabetes Schwerpunktpraxis | Meissen, Germany, 01662 |
| Praxis Dres. Prohaska / Lindner | Muehldorf, Germany, 84453 |
| Praxis Dr. Med. Claus-Michael Grimm | Muenchen, Germany, 81373 |
| Praxis Dr. Fischer & Dr. Keuthage | Muenster, Germany, 48153 |
| Gemeinschaftspraxis Dr. Uwe Böckmann/Dr. med. Maren Molkewehrum | Neumunster, Germany, 24534 |
| Praxis Dr. Med. Joachim Etter | Oberhausen, Germany, 46049 |
| IkFE Studiencenter Potsdam GMBH i.G. | Potsdam, Germany, 14469 |
| Diabetes Center Quakenbrueck | Quakenbrueck, Germany, 49610 |
| Praxis Dr. Altwicker, Dr. Kanis | Reinfeld, Germany, 23858 |
| Praxis Dr. Med. Ulrich Aigner | Rothenburg, Germany |
| Praxis Dr. Med. Sabine Sedl | Schoenberg, Germany, 23923 |
| Dres. Hiltensperger & Schaal | Schrobenhausen, Germany, 86529 |
| Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer | Schwabenheim, Germany, 55270 |
| Praxis Dr. Med. Ottmar Herfert | Stuttgart, Germany, 70469 |
| Praxis Dr. Med. Doru Popa | Veitsbronn, Germany, 90587 |
| Gemeinschaftspraxis Gerhard Steinmaier und Dr. Med. Werner Bauer | Viernheim, Germany, 68519 |
| Gemeinschaftspraxis Sauter | Wangen, Germany, 88239 |
| Praxis Dr. Med. Rudolf Matthias Remppis | Weissenhorn, Germany, 89264 |
| Praxis Dr. Med. Peter Genthner | Welzheim, Germany, 73642 |
| Gemeinschaftspraxis Dr. med. Reinhold Schneider und Christine Schneider | Wetzlar, Germany, 35584 |
| Laiko General Hospital, | Athens, Greece, GR11527 |
| Lamia General Hospital | Larisa, Greece, GR 35100 |
| Papageorgiou General Hospital | Thessaloniki, Greece, GR56403 |
| Clinica Dr. Erick Turcios | Guatemala City, Guatemala, Oficina 1114 |
| Clinica Dr. Sergio Bran | Guatemala City, Guatemala |
| Clínica y Hospital Colón del Paciente Diabético | Guatemala City, Guatemala, 01001 |
| Clínica y Hospital Colón del Paciente Diabético | Guatemala City, Guatemala, 11-49 |
| Endonutri S.A | Guatemala City, Guatemala, 01010 |
| Endonutri S. A. | Guatemala City, Guatemala, Oficina 909 |
| Szent Margit Hospita | Budapest, Hungary, 1032 |
| Szent Imre Hospital | Budapest, Hungary, 1115 |
| Károlyi Sándor Hospital | Budapest, Hungary, 1041 |
| Konszenzusplusz Kft. | Csongrád, Hungary, 6640 |
| Petz Aladar Hospital | Győr, Hungary, 9023 |
| Jósa Andras Hospital | Nyíregyháza, Hungary |
| Szte-Áok I | Szeged, Hungary, 6720 |
| Balassa Janos Hospital | Szekszárd, Hungary, 7100 |
| Zala Megyei Hospital | Zalaegerszeg, Hungary, 8900 |
| Manipal Hospital, | Bangalore, Karantaka, India, 560 017 |
| Health and Research Centre | Trivandrum, Kerela, India, 695 001 |
| Diabetes Thyroid Hormone Research Institute Pvt Ltd. | Indore, Madhya Pradesh, India, 452001 |
| Madras Diabetes Research Foundation | Chennai, Tamil Nadu, India, 500 082 |
| M. V. Hosp for Diabetes P. Ltd. 4, | Chennai, India, 13 |
| Medicity Hospital | Hyderabaad, India, 500 036 |
| Nizam's institute of medical sciences, | Hyderabaad, India, 500 082 |
| S. R. Kalla Memorial gastro and general hosp, | Jaipur, India, 302001 |
| Christian Medical College, | Vellore, India, P. O. Box. No. 3. |
| Maccabi Healthcare Services | Rishon Le Zion, Israel, 75650 |
| Ziv Medical Center | Safed, Israel, 13100 |
| 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 |
| U.O. Medicina II - Dip. Medicina Interna | Milano, Italy |
| Divisione Malattie Metaboliche e Diabetologia | Milano, Italy |
| Unità Cardio-Metabolica e Trials Clinici Dipartimento di Medicina Interna | Milano, Italy |
| S. Semplice Dip. di Endocrinologia e Diabetologia Dip. di Medicina Interna | Milano, Italy |
| U.O. Diabetologia | Olbia, Italy |
| Centro per l'Aterosclerosi Dip. di Medicina Interna | Roma, Italy |
| U.O.C. di Medicina Interna B - BMI02 Dip. Scienze Cliniche - II Clinica Medica | Roma, Italy |
| U.O.C. di Diabetologia c/o AUSL ROMA B - Sede Territoriale | Roma, Italy |
| U.O. Endocrinologia e Diabetologia | 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 |
| 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 |
| Eulji General Hospital | Seoul, Korea, Republic of |
| Ajou university hospital | Suwon, Korea, Republic of |
| Daugavpils Regional Hospital | Daugavpils, Latvia, 5417 |
| Primary Health Centre of Jaunliepaja | Liepaja, Latvia, 3401 |
| Private practice of endocrinology | Ogre, Latvia, 5001 |
| Riga Outpatient Clinic "Dziednieciba" | Riga, Latvia, 1057 |
| Center of Endocrinology | Riga, Latvia, 1002 |
| Talsi Clinical Hospital | Talsi, Latvia, 3201 |
| Endocrinology Department of Vidzemes Hospital | Valmiera, Latvia, 4201 |
| JSC "Klinikiniai sprendimai" | Alytus, Lithuania, 63257 |
| Kaunas Medical University Hospital | Kaunas, Lithuania, 50009 |
| Kaunas Dainavos Outpatient Clinic | Kaunas, Lithuania, 51270 |
| Kaunas Silainiai Outpatient Clinic | Kaunas, Lithuania, 48259 |
| Kaunas District Hospital | Kaunas, Lithuania, 45130 |
| Private Endocrinology Clinic | Vilnius, Lithuania, 09112 |
| Vilnius University Hospital Santariskiu Clinics | Vilnius, Lithuania, 08661 |
| Comité Bioetico para la Investigación Clínica S.C. | Mexico City, Durango, Mexico, 03300 |
| Unidad Metabolica y Cardiovascular S.C. | Cuernavaca, Morelos., Mexico |
| Clínica Eugenio Sue | Mexico City, Polanco chapultepec, Mexico, 11550 |
| Clínica de Diabetes de la Secretaria de Salud de Durango | Durango, Mexico, 34070 |
| Arke Estudios Clinicos S.A. de C.V. | Mexico City, Mexico, 06700 |
| Flattum legesenter | Hønefoss, Norway, 3503 |
| Randesund Helsesenter | Kristiansand, Norway |
| Sinsenklinikken | Oslo, Norway, 0580 |
| Oslo Universitetssykehus | Oslo, Norway |
| Hinnastrekanten legekontor | Stavanger, Norway, 4020 |
| Vennesla legesenter | Vennesla, Norway |
| Clinica San Miguel | Arequipa, Peru |
| Hospital Nacional Guillermo Almenara Irigoyen | Lima, Peru |
| Clinica Senor de los Milagros | Lima, Peru |
| Clinica San Borja | LIma, Peru |
| Clinica Geriatrica Militar | Lima, Peru |
| Hospital Nacional Cayetano Heredia | Lima, Peru |
| Bydgoskie Centrum Diabetologii i Endokrynologii | Bydgoszcz, Poland, 85 822 |
| NZOZ "Specjalista" Sp z o. o. | Kutno, Poland, 99 300 |
| Oddzial Chorob Wewnetrznych | Mielec, Poland, 39 300 |
| Poradnia Lekarza Rodzinnego | Poznan, Poland, 60 521 |
| Poznański Ośrodek Medyczny "NOVAMED" | Poznań, Poland, 60 773 |
| CMI Cardiologie "Dr. Pop Calin Florin" | Baia Mare, Romania, ap. 72 |
| "C. I. Parhon" Endocrinology Institute | Bucharest, Romania, district 1 |
| Medical Centre "Sanatatea Ta" SRL | Bucharest, Romania, district 2 |
| Anamed SRL | Oradea, Romania, ap. 5 |
| Medical Practice SRL | Oradea, Romania, ap. 3 |
| Emergency County Hospital Ploiesti | Ploiesti, Romania, no. 100 |
| Policlinica "Dr. Citu" | Timisoara, Romania, no. 27 |
| MEDISPEKTRUM s.r.o, | Bratislava, Slovak Republic, Slovakia, 811 02 |
| .Interna klinika, FN J.A. Reimana | Presov, Slovak Republic, Slovakia, 081 81 |
| Diabetologicka ambulancia, | Bratislava, Slovakia Republic, Slovakia, 81272 |
| Diabetologicka ambulancia | Kosice, Slovakia Republic, Slovakia, 040 01 |
| Diabetologicka ambulancia, | Lucenec, Slovakia Republic, Slovakia, 984 01 |
| NZZ Diabetologicka ambulancia | Nove Zamky, Slovakia Republic, Slovakia, 940 01 |
| Diabetes centrum s.r.o | Trencin, Slovakia Republic, Slovakia, 911 01 |
| Diabetologicka ambulancia, | Zilina, Slovakia Republic, Slovakia, 010 01 |
| Diametabol.s.r.o., | Bratislava, Slovakia, 821 07 |
| MUDr. Margita Kiripolska s.r.o | Povazska Bystrica, Slovakia, 017 01 |
| 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 |
| Hospital Militar Dr Carlos Arvelo. Final Av. José Angel Lamas. Servicio de Endocrinología. | Caracas., Venezuela, Piso 4. Urb. |