2型糖尿病におけるインスリン療法の進行に伴う課題を理解するための観察研究 (MOSAIc)
2020年2月25日 更新者：Eli Lilly and Company
インスリン使用を評価する多国籍観察研究: 治療の進行に伴う課題の理解 - MOSAic 2 型糖尿病研究
この研究の目的は、2型糖尿病患者の初期インスリン療法からより強力なレジメンへの進行に関連する特定の患者、医師、および医療システム関連の要因を特定することです。
調査の概要
状態
完了
条件
研究の種類
観察的
入学 (実際)
4299
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arkansas
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Little Rock、Arkansas、アメリカ、72204
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Florida
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Orlando、Florida、アメリカ、32806
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Wellington、Florida、アメリカ、33414
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Georgia
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Canton、Georgia、アメリカ、30114
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Illinois
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Crystal Lake、Illinois、アメリカ、60012
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Nebraska
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North Platte、Nebraska、アメリカ、69101
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Nevada
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Reno、Nevada、アメリカ、89511
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North Carolina
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Burlington、North Carolina、アメリカ、27215
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Greensboro、North Carolina、アメリカ、27408
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Morganton、North Carolina、アメリカ、28655
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Tabor City、North Carolina、アメリカ、28463
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Pennsylvania
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Johnstown、Pennsylvania、アメリカ、15905
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Levittown、Pennsylvania、アメリカ、19056
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South Carolina
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Charleston、South Carolina、アメリカ、29412
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Tennessee
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Kingsport、Tennessee、アメリカ、37660
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Texas
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Dallas、Texas、アメリカ、75235
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Fort Worth、Texas、アメリカ、76104
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Georgetown、Texas、アメリカ、78626
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Houston、Texas、アメリカ、77074
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Plano、Texas、アメリカ、75023
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Virginia
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Alexandria、Virginia、アメリカ、22304
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Richmond、Virginia、アメリカ、23219
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Abu Dhabi、アラブ首長国連邦
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Al Ain、アラブ首長国連邦
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Dubai、アラブ首長国連邦、9115
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Sharjah、アラブ首長国連邦
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Buenos Aires、アルゼンチン、CBA 1419
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Corrientes、アルゼンチン、3400
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Mendoza、アルゼンチン、5500
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Parana、アルゼンチン、3100
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Rosario、アルゼンチン、S2000DSZ
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San Juan、アルゼンチン、5400
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Cardiff、イギリス、CF5 4AD
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Chesterfield、イギリス、S40 4TF
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Avon
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Bath、Avon、イギリス、BA2 3HT
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Cornwall
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Torpoint、Cornwall、イギリス、PL11 2JW
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Greater Manchester
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Manchester、Greater Manchester、イギリス、M20 2RN
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Lancashire
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Bolton、Lancashire、イギリス、BL3 6TL
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South Yorkshire
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Doncaster、South Yorkshire、イギリス、DN9 1EP
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Warwickshire
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Atherstone、Warwickshire、イギリス、CV9 1EU
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West Glamorgan
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Swansea、West Glamorgan、イギリス、SA2 8QA
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Wiltshire
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Bradford On Avon、Wiltshire、イギリス、BA15 1DQ
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Beer Sheva、イスラエル、84350
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Beer Yaakov、イスラエル、70300
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Dimona、イスラエル、68000
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Givataim、イスラエル、53488
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Netanya、イスラエル、42470
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Petach Tikwa、イスラエル、49582
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Rishon Le Zion、イスラエル、75650
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Safed、イスラエル、13110
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Acquaviva Delle Fonti、イタリア、70021
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Ancona、イタリア、60110
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Foggia、イタリア、71100
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Lucca、イタリア、55100
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Napoli、イタリア、80131
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Parma、イタリア、43100
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Pavia、イタリア、27100
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Rome、イタリア、00168
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San Giovanni Rotondo、イタリア、71013
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Siena、イタリア、53100
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Ahmedabad、インド、380007
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Ahmedabad, Gujarat、インド、380009
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Bangalore、インド、560054
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Belgaum、インド、590001
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Hyderabaad、インド、500033
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Jaipur、インド、302020
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Kormangala、インド、560034
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Mangalore、インド、575001
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Mumbai、インド、400053
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Mysore、インド、570023
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Nagpur、インド、440025
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New Delhi、インド、110070
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Pune、インド、411035
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Alberta
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Edmonton、Alberta、カナダ、T5A 4L8
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Spruce Grove、Alberta、カナダ、T7X 2V2
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Manitoba
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Winnipeg、Manitoba、カナダ、R3C 0N2
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Newfoundland and Labrador
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St. John'S、Newfoundland and Labrador、カナダ、A1A3R5
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Ontario
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Burlington、Ontario、カナダ、L7M 4Y1
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London、Ontario、カナダ、N6A 5G6
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Smiths Falls、Ontario、カナダ、K7A 4W8
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Quebec
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Gatineau、Quebec、カナダ、J8V 2P5
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Montreal、Quebec、カナダ、H3N 1S4
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Sherbrooke、Quebec、カナダ、J1G 1B8
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Dammam、サウジアラビア、31412
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Makkah、サウジアラビア、21955
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Riyadh、サウジアラビア、245
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Taif、サウジアラビア、21944
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Barcelona、スペイン、8025
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Gerena、スペイン
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La Roca Del Valles、スペイン、8430
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Madrid、スペイン、28034
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Sevilla、スペイン、41009
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Vic、スペイン、08500
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Bosenheim、ドイツ、55545
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Dresden、ドイツ、01307
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Essen、ドイツ、45359
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Hamburg、ドイツ、22415
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Hohenmölsen、ドイツ、06679
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Kamp-Lintfort、ドイツ、47475
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Köln、ドイツ、51069
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Lambrecht、ドイツ、67466
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Schramberg、ドイツ、78713
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Speyer、ドイツ、67346
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Campina Grande Do Sul、ブラジル、83430-000
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Caxias Do Sul、ブラジル、95070560
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Fortaleza、ブラジル、60430-370
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Santa Maria、ブラジル、97015-530
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Setor Oeste/Goiania、ブラジル、74100-120
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São Paulo、ブラジル、04020-041
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Tatui、ブラジル、18270-170
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Bayamon、プエルトリコ、00956
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Carolina、プエルトリコ、00983
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Loiza、プエルトリコ、772
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Rio Grande、プエルトリコ、00745
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Rio Piedras、プエルトリコ、00921
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San Juan、プエルトリコ、00920
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Toa Baja、プエルトリコ、00949
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Villa Fontana、プエルトリコ、00983
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Aguascalientes、メキシコ、20217
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Durango、メキシコ、34080
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Guadalajara、メキシコ、44680
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Huixquilucan、メキシコ、52763
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Mexico City、メキシコ、11850
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Zapopan、メキシコ、45200
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Moscow、ロシア連邦、117997
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nizhniy Novgorod、ロシア連邦、603126
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Rostov-On-Don、ロシア連邦、344022
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Saint Petersburg、ロシア連邦、194358
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tomsk、ロシア連邦、634050
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Vsevolozhsk、ロシア連邦、188640
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Yaroslavl、ロシア連邦、150010
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Ankara、七面鳥、6560
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Canakkale、七面鳥、06310
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Diyarbakir、七面鳥、21280
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Gaziantep、七面鳥、27310
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Istanbul、七面鳥、34865
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Izmir、七面鳥
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Kahramanmaras、七面鳥、46050
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Kirikkale、七面鳥、71450
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Beijing、中国、100101
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Changchun City、中国、130041
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Chongqing、中国
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Guang Zhou、中国、510080
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Shijiazhuang、中国、50000
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Xi'An、中国、710061
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Daegu、大韓民国、705-717
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Daejeon、大韓民国、301-721
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Gangwon-Do、大韓民国、200-722
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Goyang-Si、大韓民国、412-270
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Jeju Special Self-Governing Pr、大韓民国、690-767
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Sungnam-Si、大韓民国、463-712
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Kanagawa、日本、242-0004
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Kanagawa-Ken、日本、232-0071
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
-プライマリケアおよび糖尿病専門クリニックに通う2型糖尿病患者。
説明
包含基準:
- 2型糖尿病と診断されている
- 通常のケアの過程で発症した
- -最初のインスリン療法を3か月以上行っている（承認された非インスリン抗糖尿病薬の組み合わせの有無にかかわらず）
- -治験薬または治験への登録時の手順を含む治験に同時に参加していない
- 十分な情報を得ており、データの使用について書面による同意を与えている
- アンケートに回答できるように、その国の主要言語を十分に理解していること
- -基礎ボーラス療法を開始していない（食事時の3回のインスリン注射）
除外基準:
- なし
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：他の
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
|---|
|
MOSAIC参加者
研究中に完全な治療データを持っていた、インスリン使用を評価する多国籍観察研究（MOSAIc）に登録された参加者。
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
最初のインスリン療法からのインスリン関連治療の変化を持つ参加者の数
時間枠：24 か月までのベースライン
|
多変量ロジスティック回帰モデルは、インスリン療法の変化の発生に関連するベースラインの参加者、医師、および医療システム関連の要因を調べました。
Interpersonal Processes of Care Survey [IPC] の識別ドメインは 1 ～ 5 の範囲で、スコアが高いほど差別が多いことを示し、糖尿病の苦痛尺度は 1 ～ 6 の範囲で、スコアが高いほど苦痛が大きいことを示します。
|
24 か月までのベースライン
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
低血糖および重度の低血糖エピソードの数
時間枠：24 か月までのベースライン
|
低血糖および重度の低血糖エピソードは、ベースライン来院の 1 か月前から最後の来院 (24 か月) までの完全な治療データとともに、すべての参加者によって自己報告されます。
患者は、各来院時に、前回の来院以降の低血糖を自己報告するように求められました。
ベースライン訪問時に、参加者はベースライン訪問の前月の低血糖情報を尋ねられました。
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24 か月までのベースライン
|
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研究中に処方されたインスリン療法を順守した参加者の数（研究順守）
時間枠：24 か月までのベースライン
|
MOSAIC の参加者は、「過去 7 日間で、インスリン注射を何回逃しましたか?」という質問に答えました。
各訪問で、参加者が「ショットを逃したことはありません」または「いくつかのショットを逃した」と回答した場合、参加者は訪問順守と定義されました。
彼/彼女が次のいずれかに答えた場合、彼らは訪問遵守者ではないと定義されました：「私は私のショットの約半分を逃した」、「私は私のショットのほとんどを逃した」、または「私はすべてのショットを逃した」。
参加者は、少なくとも次の場合に研究遵守であると定義されます。
|
24 か月までのベースライン
|
|
研究終了までに個別のHbA1c目標を達成した参加者の数
時間枠：24 か月までのベースライン
|
糖尿病管理の実践は MOSAIC に代表される国によって異なるため、目標を達成するためのより適切な尺度は、研究の開始時に各患者に設定された個別の目標です。
|
24 か月までのベースライン
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Matsuba I, Kawata T, Ajima M, Umezawa S, Kaneshiro M, Asakura T, Machimura H, Sawa T, Tanaka K, Takeda H, Imaoka T, Kanamori A. Multinational Observational Study to Understand Insulin Treatment Intensification: Japanese Subgroup Analysis of the MOSAIc Study. Diabetes Ther. 2022 Feb;13(2):265-274. doi: 10.1007/s13300-021-01195-8. Epub 2022 Jan 6.
- Caballero AE, Nordstrom BL, Liao B, Fan L, Zhang N, Fraeman KH, Perez-Nieves M. Individualized HbA1c target selection and achievement in the Multinational Observational Study Assessing Insulin Use (MOSA1c) type 2 diabetes study. J Diabetes Complications. 2021 Nov;35(11):108011. doi: 10.1016/j.jdiacomp.2021.108011. Epub 2021 Jul 30.
- Linetzky B, Curtis B, Frechtel G, Montenegro R Jr, Escalante Pulido M, Stempa O, de Lana JM, Gagliardino JJ. Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data. Diabetol Metab Syndr. 2016 Jul 22;8:41. doi: 10.1186/s13098-016-0157-1. eCollection 2016.
- Matsuba I, Sawa T, Kawata T, Kanamori A, Jiang D, Machimura H, Takeda H, Han JH, Wang K, Tanaka K, Shen L, Ajima M, Kaneshiro M, Kim SW, Umezawa S, Asakura T, Suzuki S, Kim SC. Cross-National Variation in Glycemic Control and Diabetes-Related Distress Among East Asian Patients Using Insulin: Results from the MOSAIc Study. Diabetes Ther. 2016 Jun;7(2):349-60. doi: 10.1007/s13300-016-0178-7. Epub 2016 Jun 2.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年7月1日
一次修了 (実際)
2015年9月1日
研究の完了 (実際)
2015年9月1日
試験登録日
最初に提出
2011年7月21日
QC基準を満たした最初の提出物
2011年7月21日
最初の投稿 (見積もり)
2011年7月25日
学習記録の更新
投稿された最後の更新 (実際)
2020年3月9日
QC基準を満たした最後の更新が送信されました
2020年2月25日
最終確認日
2020年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。