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Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes

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研究单位: [1]Novo Nordisk A/S [2]Anhui Provincial Hospital,Hefei,Anhui,China,230001 [3]The First Affiliated Hospital of Anhui Medical University,Hefei,Anhui,China,230061 [4]Beijing Chao-yang Hospital, Capital Medical University,Beijing,Beijing,China,100020 [5]Chinese People''s Liberation Army General Hospital,Beijing,Beijing,China,100853 [6]Beijing Pinggu Hospital,Beijing,Beijing,China,101200 [7]Chongqing University Three Gorges Hospital,ChongQing,Chongqing,China,404000 [8]Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy,Guangzhou,Guangdong,China,510120 [9]The 2nd Affiliated Hospital of Shantou Uni Medical College,Shantou,Guangdong,China,515065 [10]The Second Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi,China,53007 [11]Cangzhou People''s Hospital,Cangzhou,Hebei,China,061000 [12]Harrison International Peace Hospital,Hengshui,Hebei,China,053000 [13]The Second Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,050000 [14]Tangshan Gongren Hospital,Tangshan,Hebei,China,063000 [15]Yueyang Central Hospital,Yueyang,Hunan,China,414000 [16]Inner Mongolia People''s Hospital,Huhehaote,Inner Mongolia,China,010020 [17]The affiliated hospital of Inner Mongolia Medical University,Huhhot,Inner Mongolia,China,010050 [18]Changzhou No.2 People''s Hospital, Yanghu Branch,Changzhou,Jiangsu,China,213003 [19]The Second Affiliated Hospital of Nanjing Medical University_Nanjing,Nanjing,Jiangsu,China,210011 [20]Jiangsu Province Hospital,Nanjing,Jiangsu,China,210029 [21]Nanjing Jiangning Hospital,Nanjing,Jiangsu,China,211199 [22]Suzhou Municipal Hospital,Suzhou,Jiangsu,China,215002 [23]The First Affiliated Hospital of Soochow University,Suzhou,Jiangsu,China,215006 [24]The Affiliated Hospital of Jiangsu University_Zhenjiang,Zhenjiang,Jiangsu,China,212001 [25]Jiangxi Provincial People''s Hospital,Nanchang,Jiangxi,China,330006 [26]The first hospital of Jilin University,Changchun,Jilin,China,130021 [27]China-Japan Union Hospital of Jilin University_Changchun,Changchun,Jilin,China,130033 [28]The Second Hospital of Jilin University,Changchun,Jilin,China,130041 [29]Qinghai Provincial People''s Hospital,Xining,Qinghai,China,810007 [30]Jinan Central Hospital,Ji''nan,Shandong,China,250013 [31]Shanghai Tenth People''s Hsopital, Tongji University,Shanghai,Shanghai,China,200072 [32]Shanghai Fifth People''s Hospital,Shanghai,Shanghai,China,200240 [33]Central Hospital of Minhang District,Shanghai,Shanghai,China,201199 [34]General Hospital of Tianjin Medical University,Tianjin,Tianjin,China,300052 [35]First Affiated Hospital of Kunming Medical University,Kunming,Yunnan,China,650032 [36]The First People''s Hospital of Yunnan Province,Kunming,Yunnan,China,650032 [37]The Second Affiliated Hospital of Kunming Medical University,Kunming,Yunnan,China,650101

研究目的:
Fast-acting insulin aspart (faster aspart) will be tested to see how well it works and if it is safe. The study compares 2 medicines for type 1 and type 2 diabetes - faster aspart (a new medicine) and insulin aspart (a medicine doctors can already prescribe). Participants will either get faster aspart or insulin aspart (NovoRapid®) - which treatment is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day: 3 injections 0-2 minutes before breakfast, lunch and dinner and 1 injection at the same time every day. All study medicines are provided in pens. A pen is a tool to inject insulin under the skin.The study will last for about 7 months (30 weeks). Participants will have 11 clinic visits and 17 phone contacts with the study doctor. At 8 clinic visits participants will have blood samples taken. At 3 clinic visits participants cannot eat or drink (water is allowed) 8 hours before the visits - at 2 of these visits participants will be asked to drink a liquid meal and to stay at the clinic for about 5 hours. Participants will fill in a diary the last 3 days before the visits/phone contacts. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

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