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A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes

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研究单位: [1]Novo Nordisk A/S [2]Maison des diabétiques El Harrach,Algiers,Algeria,16000 [3]Department of internal medicine hospital (CHU) of BIRTRARIA,Algiers,Algeria,16003 [4]Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.,Porto Alegre,Rio Grande Do Sul,Brazil,90430-001 [5]CPQuali Pesquisa Clínica Ltda,São Paulo,Sao Paulo,Brazil,01228-000 [6]CPCLIN - Centro de Pesquisas Clínicas,São Paulo,Sao Paulo,Brazil,01228-200 [7]Anhui Provincial Hospital,Hefei,Anhui,China,230001 [8]The First Affiliated Hospital of Anhui Medical University,Hefei,Anhui,China,230061 [9]Peking University People's Hospital,Beijing,Beijing,China,100044 [10]Peking University Shougang Hospital,Beijing,Beijing,China,100144 [11]Beijing Pinggu Hospital,Beijing,Beijing,China,101200 [12]Second Affliated Hospital of Chongqing Medical University,Chongqing,Chongqing,China,400010 [13]900th Hospital of Joint Logistics Support Force,Fuzhou,Fujian,China,350025 [14]The Second Affiliated Hospital of Fujian Medical University,Quanzhou,Fujian,China,362000 [15]Shunde Hospital of Southern Medical University,Foshan,Guangdong,China,528399 [16]Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy,Guangzhou,Guangdong,China,510120 [17]Guangzhou Panyu Central Hospital,Guangzhou,Guangdong,China,511400 [18]Huizhou Central People's Hospital,Huizhou,Guangdong,China,516001 [19]The 2nd Affiliated Hospital of Shantou Uni Medical College,Shantou,Guangdong,China,515065 [20]Cangzhou People's Hospital,Cangzhou,Hebei,China,061000 [21]Harrison International Peace Hospital,Hengshui,Hebei,China,053000 [22]The Second Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,050000 [23]Huaihe Hospital of Henan University,Kaifeng,Henan,China,475000 [24]The First Affiliated Hospital of Henan university of Science,Luoyang,Henan,China,471003 [25]Zhengzhou First People's Hospital,Zhengzhou,Henan,China,450004 [26]Taihe Hospital,Shiyan,Hubei,China,442008 [27]Wuhan Puai Hosptial,Wuhan,Hubei,China,430034 [28]Changsha Central Hospital,Changsha,Hunan,China,410018 [29]Chenzhou No.1 People's Hospital,Chenzhou,Hunan,China,423000 [30]The First Affiliated Hospital Of University Of South China,Hengyang,Hunan,China,421001 [31]Zhuzhou Central Hospital,Zhuzhou,Hunan,China,412007 [32]Changzhou No.2 People's Hospital, Yanghu Branch,Changzhou,Jiangsu,China,213003 [33]The First People's Hospital of Changzhou,Changzhou,Jiangsu,China,213003 [34]The Second Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu,China,210011 [35]Nanjing Jiangning Hospital,Nanjing,Jiangsu,China,211106 [36]Sir Run Run Hospital Nanjing Medical University,Nanjing,Jiangsu,China,211166 [37]The Second Affiliated Hospital of Soochow University,Suzhou,Jiangsu,China,215004 [38]The First Affiliated Hospital of Soochow University,Suzhou,Jiangsu,China,215006 [39]Wuxi People's Hospital,Wuxi,Jiangsu,China,214023 [40]The Affiliated Hospital of Xuzhou Medical University,Xuzhou,Jiangsu,China,221002 [41]The Affiliated Hospital of Jiangsu University,Zhenjiang,Jiangsu,China,212001 [42]Pingxiang People's Hospital,Pingxiang,Jiangxi,China,337055 [43]Jilin Province People's Hospital,Changchun,Jilin,China,130021 [44]China-Japan Union Hospital of Jilin University,Changchun,Jilin,China,130033 [45]The Second Hospital of Jilin University,Changchun,Jilin,China,130041 [46]General Hospital of Ningxia Medical University,Yinchuan,Ningxia,China,750004 [47]Qinghai Provincial People's Hospital,Xining,Qinghai,China,810007 [48]The second Affiliated Hospital of Xi'an Jiaotong University,Xi'an,Shaanxi,China,710004 [49]Jinan Central Hospital Affiliated to Shandong University,Jinan,Shandong,China,250013 [50]The Affiliated Hospital of Qingdao Medical College,Qingdao,Shandong,China,266003 [51]Weifang People's Hospital,Weifang,Shandong,China,261041 [52]Shanghai Pudong New Area People's Hospital,Pudong New District,Shanghai,China,201200 [53]Shanghai Huashan Hospital, Affiliated to Fudan University,Shanghai,Shanghai,China,200040 [54]Tongji Hospital of Tongji university,Shanghai,Shanghai,China,200065 [55]Shanghai Tenth People's Hsopital, Tongji University,Shanghai,Shanghai,China,200072 [56]Dongfang Hospital Affiliated to Shanghai Tongji University,Shanghai,Shanghai,China,200120 [57]The Fifth People's Hospital of Shanghai,Shanghai,Shanghai,China,200240 [58]Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine,Shanghai,Shanghai,China,200336 [59]General Hospital of Tianjin Medical University,Tianjin,Tianjin,China,300052 [60]The Second Hospital of Tianjin Medical University,Tianjin,Tianjin,China,300211 [61]First Affiated Hospital of Kunming Medical University,Kunming,Yunnan,China,650032 [62]The First People's Hospital of Yunnan Province,Kunming,Yunnan,China,650032 [63]The Second Affiliated Hospital of Kunming Medical University,Kunming,Yunnan,China,650101 [64]The 2nd Affi Hosp of Zhejiang Univer School of Medicine,Hangzhou,Zhejiang,China,310009 [65]The Third Xiangya Hospital of Central South University,Changsha,China,410013 [66]Nemocnice milosrdnych bratri,Brno,Czechia,63900 [67]DIAMIN,Chrudim,Czechia,537 01 [68]Interna a diabetologie MUDr. Vodickova,Liberec,Czechia,46001 [69]MUDr. Michala Pelikanova,Praha 4,Czechia,140 00 [70]CCR Prague,Praha,Czechia,130 00 [71]Prince of Wales Hospital,Shatin, New Territories,Hong Kong [72]SC Grand Med SRL,Oradea,Bihor,Romania,410025 [73]S.C. Endodigest S.R.L.,Oradea,Bihor,Romania,410151 [74]SC Centru Medical Dr. Negrisanu SRL,Timisoara,Timis,Romania,300456 [75]SC Nutrilife SRL,Bucharest,Romania,13682 [76]Clinic of Diabetes Constanta,Constanta,Romania,900591 [77]Clinical County Emergency Hosp,Oradea,Romania,410169 [78]Clinical Hospital Centre Dragisa Misovic,Belgrade,Serbia,11000 [79]Endocrinology, Diabetes and Metabolism Diseases Clinic,Belgrade,Serbia,11000 [80]Clinical Hospital Centre Zemun,Belgrade,Serbia,11080 [81]GCT,Arcadia,Gauteng,South Africa,0083 [82]Dr R Dulabh,Johannesburg,Gauteng,South Africa,1812 [83]Newtown Clinical Research,Johannesburg,Gauteng,South Africa,2001 [84]WITS Clinical Research,Johannesburg,Gauteng,South Africa,2193 [85]Clinresco Centres (Pty) Ltd,Kempton Park,Gauteng,South Africa,1619 [86]Setshaba Research Centre,Soshanguve,Gauteng,South Africa,0152 [87]Armansis Medical Centre,Brits,North West,South Africa,0250 [88]Cape Town Medical Research Centre,Kuilsriver,Western Cape,South Africa,7580

研究目的:
This study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and sitagliptin (a medicine doctors can already prescribe). Participants will either get oral semaglutide or sitagliptin - which treatment is decided by chance. Participants will get 2 tablets a day to take first thing in the morning on an empty stomach. Only 1 tablet has study medicine in it. The other tablet is a dummy medicine (placebo). After taking the semaglutide tablet, participants may not eat or drink anything for at least 30 minutes. After the 30 minutes, participants must take the sitagliptin tablet. Then participants can have their first meal of the day and take any other medicines they may need, including their metformin. The study will last for about 7 months (33 weeks). Participants will have 8 clinic visits and 1 phone call with the study doctor. At all 8 of the clinic visits, participants will have blood samples taken.

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