- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01400971
Observační studie k pochopení problémů spojených s progresí inzulinové terapie u diabetu 2. typu (MOSAIc)
25. února 2020 aktualizováno: Eli Lilly and Company
Mnohonárodní observační studie hodnotící užívání inzulínu: Porozumění výzvám spojeným s progresí terapie – MOSAIc studie diabetu 2. typu
Účelem této studie je identifikovat specifické faktory související s pacientem, lékařem a zdravotním systémem spojené s progresí k intenzivnějšímu režimu od počáteční inzulínové terapie u pacientů s diabetem 2. typu.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Pozorovací
Zápis (Aktuální)
4299
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Buenos Aires, Argentina, CBA 1419
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Corrientes, Argentina, 3400
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Mendoza, Argentina, 5500
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Parana, Argentina, 3100
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Rosario, Argentina, S2000DSZ
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San Juan, Argentina, 5400
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Campina Grande Do Sul, Brazílie, 83430-000
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Caxias Do Sul, Brazílie, 95070560
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Fortaleza, Brazílie, 60430-370
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Santa Maria, Brazílie, 97015-530
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Setor Oeste/Goiania, Brazílie, 74100-120
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São Paulo, Brazílie, 04020-041
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Tatui, Brazílie, 18270-170
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Ahmedabad, Indie, 380007
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Ahmedabad, Gujarat, Indie, 380009
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Bangalore, Indie, 560054
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Belgaum, Indie, 590001
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Hyderabaad, Indie, 500033
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Jaipur, Indie, 302020
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Kormangala, Indie, 560034
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Mangalore, Indie, 575001
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Mumbai, Indie, 400053
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Mysore, Indie, 570023
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Nagpur, Indie, 440025
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New Delhi, Indie, 110070
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Pune, Indie, 411035
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Acquaviva Delle Fonti, Itálie, 70021
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Ancona, Itálie, 60110
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Foggia, Itálie, 71100
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Lucca, Itálie, 55100
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Napoli, Itálie, 80131
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Parma, Itálie, 43100
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Pavia, Itálie, 27100
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Rome, Itálie, 00168
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San Giovanni Rotondo, Itálie, 71013
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Siena, Itálie, 53100
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Beer Sheva, Izrael, 84350
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Beer Yaakov, Izrael, 70300
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Dimona, Izrael, 68000
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Givataim, Izrael, 53488
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Netanya, Izrael, 42470
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Petach Tikwa, Izrael, 49582
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Rishon Le Zion, Izrael, 75650
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Safed, Izrael, 13110
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Kanagawa, Japonsko, 242-0004
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Kanagawa-Ken, Japonsko, 232-0071
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Alberta
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Edmonton, Alberta, Kanada, T5A 4L8
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Spruce Grove, Alberta, Kanada, T7X 2V2
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Manitoba
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Winnipeg, Manitoba, Kanada, R3C 0N2
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Newfoundland and Labrador
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St. John'S, Newfoundland and Labrador, Kanada, A1A3R5
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Ontario
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Burlington, Ontario, Kanada, L7M 4Y1
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London, Ontario, Kanada, N6A 5G6
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Smiths Falls, Ontario, Kanada, K7A 4W8
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Quebec
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Gatineau, Quebec, Kanada, J8V 2P5
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Montreal, Quebec, Kanada, H3N 1S4
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Sherbrooke, Quebec, Kanada, J1G 1B8
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Daegu, Korejská republika, 705-717
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Daejeon, Korejská republika, 301-721
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Gangwon-Do, Korejská republika, 200-722
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Goyang-Si, Korejská republika, 412-270
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Jeju Special Self-Governing Pr, Korejská republika, 690-767
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Sungnam-Si, Korejská republika, 463-712
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Ankara, Krocan, 6560
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Canakkale, Krocan, 06310
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Diyarbakir, Krocan, 21280
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Gaziantep, Krocan, 27310
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Istanbul, Krocan, 34865
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Izmir, Krocan
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Kahramanmaras, Krocan, 46050
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Kirikkale, Krocan, 71450
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Aguascalientes, Mexiko, 20217
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Durango, Mexiko, 34080
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Guadalajara, Mexiko, 44680
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Huixquilucan, Mexiko, 52763
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Mexico City, Mexiko, 11850
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Zapopan, Mexiko, 45200
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Bosenheim, Německo, 55545
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Dresden, Německo, 01307
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Essen, Německo, 45359
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Hamburg, Německo, 22415
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Hohenmölsen, Německo, 06679
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Kamp-Lintfort, Německo, 47475
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Köln, Německo, 51069
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Lambrecht, Německo, 67466
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Schramberg, Německo, 78713
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Speyer, Německo, 67346
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Bayamon, Portoriko, 00956
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Carolina, Portoriko, 00983
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Loiza, Portoriko, 772
- 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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Rio Grande, Portoriko, 00745
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Rio Piedras, Portoriko, 00921
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San Juan, Portoriko, 00920
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Toa Baja, Portoriko, 00949
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Villa Fontana, Portoriko, 00983
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Moscow, Ruská Federace, 117997
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Nizhniy Novgorod, Ruská Federace, 603126
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Rostov-On-Don, Ruská Federace, 344022
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Saint Petersburg, Ruská Federace, 194358
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Tomsk, Ruská Federace, 634050
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Vsevolozhsk, Ruská Federace, 188640
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Yaroslavl, Ruská Federace, 150010
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Dammam, Saudská arábie, 31412
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Makkah, Saudská arábie, 21955
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Riyadh, Saudská arábie, 245
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Taif, Saudská arábie, 21944
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Abu Dhabi, Spojené arabské emiráty
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Al Ain, Spojené arabské emiráty
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Dubai, Spojené arabské emiráty, 9115
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Sharjah, Spojené arabské emiráty
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Cardiff, Spojené království, CF5 4AD
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Chesterfield, Spojené království, S40 4TF
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Avon
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Bath, Avon, Spojené království, BA2 3HT
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Cornwall
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Torpoint, Cornwall, Spojené království, PL11 2JW
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Greater Manchester
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Manchester, Greater Manchester, Spojené království, M20 2RN
- 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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Lancashire
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Bolton, Lancashire, Spojené království, BL3 6TL
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South Yorkshire
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Doncaster, South Yorkshire, Spojené království, DN9 1EP
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Warwickshire
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Atherstone, Warwickshire, Spojené království, CV9 1EU
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West Glamorgan
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Swansea, West Glamorgan, Spojené království, SA2 8QA
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Wiltshire
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Bradford On Avon, Wiltshire, Spojené království, BA15 1DQ
- 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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Arkansas
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Little Rock, Arkansas, Spojené státy, 72204
- 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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Florida
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Orlando, Florida, Spojené státy, 32806
- 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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Wellington, Florida, Spojené státy, 33414
- 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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Georgia
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Canton, Georgia, Spojené státy, 30114
- 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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Illinois
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Crystal Lake, Illinois, Spojené státy, 60012
- 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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Nebraska
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North Platte, Nebraska, Spojené státy, 69101
- 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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Nevada
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Reno, Nevada, Spojené státy, 89511
- 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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North Carolina
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Burlington, North Carolina, Spojené státy, 27215
- 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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Greensboro, North Carolina, Spojené státy, 27408
- 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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Morganton, North Carolina, Spojené státy, 28655
- 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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Tabor City, North Carolina, Spojené státy, 28463
- 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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Pennsylvania
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Johnstown, Pennsylvania, Spojené státy, 15905
- 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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Levittown, Pennsylvania, Spojené státy, 19056
- 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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South Carolina
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Charleston, South Carolina, Spojené státy, 29412
- 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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Tennessee
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Kingsport, Tennessee, Spojené státy, 37660
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Texas
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Dallas, Texas, Spojené státy, 75235
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Fort Worth, Texas, Spojené státy, 76104
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Georgetown, Texas, Spojené státy, 78626
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Houston, Texas, Spojené státy, 77074
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Plano, Texas, Spojené státy, 75023
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Virginia
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Alexandria, Virginia, Spojené státy, 22304
- 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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Richmond, Virginia, Spojené státy, 23219
- 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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Beijing, Čína, 100101
- 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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Changchun City, Čína, 130041
- 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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Chongqing, Čína
- 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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Guang Zhou, Čína, 510080
- 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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Shijiazhuang, Čína, 50000
- 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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Xi'An, Čína, 710061
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Barcelona, Španělsko, 8025
- 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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Gerena, Španělsko
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La Roca Del Valles, Španělsko, 8430
- 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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Madrid, Španělsko, 28034
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Sevilla, Španělsko, 41009
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Vic, Španělsko, 08500
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Pacienti s diabetem 2. typu navštěvující kliniky primární péče a specializované diabetologické ambulance.
Popis
Kritéria pro zařazení:
- Byla jim diagnostikována cukrovka 2. typu
- Nechte se předvést v rámci běžné péče
- byli na své počáteční inzulínové terapii ≥ 3 měsíce (s nebo bez jakékoli kombinace schválených neinzulínových antidiabetik)
- Neúčastní se současně studie, která zahrnuje zkoušený lék nebo postup při vstupu do studie
- Byli plně informováni a dali písemný souhlas s použitím svých údajů
- Mít dostatečnou znalost primárního jazyka země, aby byli schopni vyplnit dotazníky
- Nezahájili bazální bolusovou terapii (tři injekce inzulínu během jídla)
Kritéria vyloučení:
- Žádný
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Observační modely: Jiný
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
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Účastníci MOSAIc
Účastníci zařazení do mnohonárodní observační studie hodnotící užívání inzulínu (MOSAIc), kteří měli během studie kompletní údaje o léčbě.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Počet účastníků se změnou léčby související s inzulínem oproti počáteční inzulínové terapii
Časové okno: Výchozí stav po 24 měsících
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Multivariabilní logistický regresní model zkoumal základní faktory související s účastníky, lékařem a zdravotnickým systémem související s výskytem jakékoli změny v inzulínové terapii.
Diskriminační doména průzkumu mezilidských procesů péče [IPC] se pohybuje od 1 do 5, přičemž vyšší skóre ukazuje na větší diskriminaci a škála diabetu distress se pohybuje od 1 do 6, přičemž vyšší skóre ukazuje na větší úzkost.
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Výchozí stav po 24 měsících
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Počet hypoglykemických a těžkých hypoglykemických epizod
Časové okno: Výchozí stav po 24 měsících
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Hypoglykémie a epizody těžké hypoglykemie si všichni účastníci sami hlásí s kompletními údaji o léčbě od jednoho měsíce před základní návštěvou až do poslední návštěvy (24 měsíců).
Pacienti byli při každé návštěvě požádáni, aby sami uvedli jakoukoli hypoglykémii od jejich poslední návštěvy.
Při základní návštěvě byli účastníci požádáni o informace o hypoglykémii za měsíc před základní návštěvou.
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Výchozí stav po 24 měsících
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Počet účastníků dodržujících předepsanou inzulínovou terapii během studie (adherent ve studii)
Časové okno: Výchozí stav po 24 měsících
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Účastníci MOSAIC odpověděli na otázku: „Jak často jste za posledních 7 dní vynechali injekci inzulínu?“.
Při každé návštěvě byli účastníci definováni jako přívrženci návštěvy, pokud účastník odpověděl „Nezmeškal jsem žádné záběry“ nebo „Zmeškal jsem některé ze svých záběrů“.
Byli definováni jako nenávštívníci, pokud odpověděl/a na některou z následujících otázek: „Nestihl jsem asi polovinu svých záběrů“, „Nestihl jsem většinu záběrů“ nebo „Nestihl jsem všechny záběry“.
Účastník je definován jako přívrženec studie, pokud alespoň: 4 z 5 navštěvují přívržence.
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Výchozí stav po 24 měsících
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Počet účastníků, kteří do konce studie dosáhli svého personalizovaného cíle HbA1c
Časové okno: Výchozí stav po 24 měsících
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Vzhledem k tomu, že postupy léčby diabetu se v jednotlivých zemích zastoupených v MOSAIC liší, je vhodnější měřítko dosažení cíle personalizovaný cíl, který byl pro každého pacienta stanoven na začátku studie.
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Výchozí stav po 24 měsících
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2011
Primární dokončení (Aktuální)
1. září 2015
Dokončení studie (Aktuální)
1. září 2015
Termíny zápisu do studia
První předloženo
21. července 2011
První předloženo, které splnilo kritéria kontroly kvality
21. července 2011
První zveřejněno (Odhad)
25. července 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
9. března 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. února 2020
Naposledy ověřeno
1. února 2020
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 14056
- F3Z-MC-B010 (Jiný identifikátor: Eli Lilly and Company)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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