556
Participants
Start Date
April 30, 2009
Primary Completion Date
November 30, 2010
Study Completion Date
November 30, 2010
Canakinumab
Canakinumab lyophilized cake (25 mg and 150 mg in individual 6 mL glass vials ) was reconstituted and then used to dilute the 25mg or 150mg solutions to make 5mg, 15mg and 50mg injections.
Metformin
Before randomization, in drug naïve patients at a dose of 1000 mg with the evening meal or 500 mg b.i.d. (twice daily) with two main meals. At the randomization visit, patients were prescribed with no less than 1,000mg/day.
Placebo
Placebo lyophilized cake will be reconstituted and then used to dilute the 25mg or 150mg solutions to make 5mg, 15mg and 50mg injections.
emovis GmbH, Berlin
Asklepios Klinik St. Georg, Hamburg
Städt. Kankenhaus Nordstadt, Hanover
Praxis F. Franzmann, Bad Oeynhausen
Praxis Dr. Klein, Schenklengsfeld
Johannes Gutenberg-Universität Mainz, Mainz
Zentrum für Klinische Forschung Neuwied (ZKSN), Neuwied
Forschungszentrum Ruhr, KliFoCenter GmbH, Witten
Praxis Dr. Alawi, Saarlouis
Praxis Dr. Stütz, Bretten
Novartis Investigative Site, Santa Monica
Praxis Dr. Wunderer, Nuremberg
Anasazi Internal Medicine, Phoenix
Whittier Institute of Diabetes, La Jolla
Novartis Investigative Site, Los Gatos
Orange County Research Center, Tustin
Novartis Investigative Site, Atlanta
Deaconess Clinic, Evansville
Novartis Investigative Site, Jackson
Novartis Investigative Site, Picayune
Novartis Investigative Site, Trenton
Diabetes Research Center, Columbus
Tri-State Medical Group, Beaver
Preferred Primary Care Physicians, Pittsburgh
Novartis Investigative Site, Columbia
R/D Clinical Research, Lake Jackson
Novartis Investigative Site, Pasadena
Novartis Investigative Site, San Antonio
Medical Research Initiatives Inc, Virginia Beach
Private Practice - DEMEULEMEESTER, Gozée
Novartis Investigative Site, Heist-op-den-Berg
UZ Brussel, Jette
Novartis Investigative Site, Hong Kong
Gemeinschaftspraxis und Dialysezentrum Karlstraße, Düsseldorf
Fővárosi Önkormányzat Péterfy Sándor Utcai Kórház - Rendelőintézet és Baleseti Központ, Budapest
Sandor Karolyi Hospital, Budapest
Semmelweiss Medical University, Budapest
Kenezy Gyula Korhaz, Debrecen
Szegedi Egyetem, Szeged
Zala Megyei Korhaz, Zalaegerszeg
Bangalore Diabetes Hospital, Bangalore
Gokula Metropolis Clinical Research Centre, Bangalore
Jnana Sanjeevini Medical Center, Bangalore
SAMATVAM, Bangalore
Madras Diabetes Reasearch Foundation, Chennai
Nizam's Institute of Medical Sciences, Hyderabaad
Diabetes Thyroid Hormone Research Institute Pvt. Ltd., Indore
S R Kalla Memorial Gastro & General Hospital, Jaipur
Amrita Institute of Medical Sciences and Research Center, Kochi
Pitale Diabetes & Hormone Centre, Nagpur
Health and Research Centre, Trivandrum
King George Hospital, Visakhapatnam
Novartis Investigative Site, Minato-ku
Kokura Medical Center, Kitakyushu
Seino Internal Medicine Clinic, Kōriyama
Geriatrics Research Institute Hospital, Maebashi
Takagi Hospital, Ohkawa
Sakai Hospital Kinki University School of Medicine, Sakai
Instituto Delgado de Investigacion Medica, Arequipa
Clinica Chiclayo, Chiclayo
Hospital Nacional Cayetano Heredia, San Martín de Porres
Centro de Investigacion Clinica Trujillo, Trujillo
Ambulatory of Institute of Nutrition Diseases and Diabetes, Bucharest
"Medical Centre Sanatatea ta", Bucharest
Novartis Investigative Site, Bucharest
Policlinica Dr. Citu Timisoara, Timișoara
203 Maxwell Centre, Durban
Parklands Medical Centre, Durban
St Augustines Medical Centre, Durban
Synapta Clinical Research Centre, Durban
Drs Essack and Mitha, Johannesburg
26 Daffodil Street, KwaDukuza
PE Greenacres Hospital, Port Elizabeth
Ankara Ataturk Training and Research Hospital, Ankara
Gulhane Askeri Tip Akademisi, Ankara
Hacettepe University Medical Faculty, Ankara
S.B. Yildirim Beyazit Training and Research Hospital, Ankara
Istanbul University Cardiology Institute, Istanbul
Ege University Medical Faculty, Izmir
Hayat Tip Merkezi (Hayat Medical Center) Deapartment of Internal Diseases, Karabük
Birmingham Heartlands Hospital, Birmingham
Royal Bournemouth Hospital, Bournemouth
Rowden Medical Partnership, Wiltshire
DIM Clinica Privada, Buenos Aires
Centro Medico Viamonte, Buenos Aires
Consultorios Asociados de Endocrinologia, Buenos Aires
Clinica de Fracturas y Ortopedia, Mar del Plata
Hospital Juan Ramon Vidal, Corrientes
Instituto de Investigaciones Biomedicas, Santa Fe
Centro de Investigaciones Clinicas del Litoral, Santa Fe
Novartis Investigative Site, Rosario Santa Fe
GWT-TUB GmbH, Dresden
Diabeteszentrum Hohenmölsen, Hohenmölsen
Praxis Dr. Kosch, Pirna
National Hospital Organization Nagoya Medical Center, Nagoya
Saiseikai Fukuoka General Hospital, Fukuoka
Kyushu Rosai Hospital, Kitakyushu
NHO Yokohama Medical Center, Yokohama
Musashikoganei Clinic, Koganei
Fujikoshi Hospital, Toyama
Novartis Investigative Site, Pusan
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, Suwon
Morriston Hospital, Swansea
Lead Sponsor
Novartis
INDUSTRY