- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01400971
Un estudio observacional para comprender los desafíos asociados con la progresión de la terapia con insulina en la diabetes tipo 2 (MOSAIc)
25 de febrero de 2020 actualizado por: Eli Lilly and Company
Un estudio observacional multinacional que evalúa el uso de insulina: comprensión de los desafíos asociados con la progresión de la terapia: el estudio de diabetes tipo 2 MOSAIc
El propósito de este estudio es identificar factores específicos relacionados con el paciente, el médico y el sistema de salud asociados con la progresión a un régimen más intensivo desde la terapia inicial con insulina para pacientes con diabetes tipo 2.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
4299
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bosenheim, Alemania, 55545
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Dresden, Alemania, 01307
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Essen, Alemania, 45359
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Hamburg, Alemania, 22415
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Hohenmölsen, Alemania, 06679
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Kamp-Lintfort, Alemania, 47475
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Köln, Alemania, 51069
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Lambrecht, Alemania, 67466
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Schramberg, Alemania, 78713
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Speyer, Alemania, 67346
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Dammam, Arabia Saudita, 31412
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Makkah, Arabia Saudita, 21955
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Riyadh, Arabia Saudita, 245
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Taif, Arabia Saudita, 21944
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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, Brasil, 83430-000
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Caxias Do Sul, Brasil, 95070560
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Fortaleza, Brasil, 60430-370
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Santa Maria, Brasil, 97015-530
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Setor Oeste/Goiania, Brasil, 74100-120
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São Paulo, Brasil, 04020-041
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Tatui, Brasil, 18270-170
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Alberta
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Edmonton, Alberta, Canadá, T5A 4L8
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Spruce Grove, Alberta, Canadá, T7X 2V2
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Manitoba
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Winnipeg, Manitoba, Canadá, R3C 0N2
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Newfoundland and Labrador
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St. John'S, Newfoundland and Labrador, Canadá, A1A3R5
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Ontario
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Burlington, Ontario, Canadá, L7M 4Y1
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London, Ontario, Canadá, N6A 5G6
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Smiths Falls, Ontario, Canadá, K7A 4W8
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Quebec
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Gatineau, Quebec, Canadá, J8V 2P5
- 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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Montreal, Quebec, Canadá, H3N 1S4
- 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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Sherbrooke, Quebec, Canadá, J1G 1B8
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Daegu, Corea, república de, 705-717
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Daejeon, Corea, república de, 301-721
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Gangwon-Do, Corea, república de, 200-722
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Goyang-Si, Corea, república de, 412-270
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Jeju Special Self-Governing Pr, Corea, república de, 690-767
- 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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Sungnam-Si, Corea, república de, 463-712
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Abu Dhabi, Emiratos Árabes Unidos
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Al Ain, Emiratos Árabes Unidos
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Dubai, Emiratos Árabes Unidos, 9115
- 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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Sharjah, Emiratos Árabes Unidos
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Barcelona, España, 8025
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Gerena, España
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La Roca Del Valles, España, 8430
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Madrid, España, 28034
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Sevilla, España, 41009
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Vic, España, 08500
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72204
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Florida
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Orlando, Florida, Estados Unidos, 32806
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Wellington, Florida, Estados Unidos, 33414
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Georgia
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Canton, Georgia, Estados Unidos, 30114
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Illinois
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Crystal Lake, Illinois, Estados Unidos, 60012
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Nebraska
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North Platte, Nebraska, Estados Unidos, 69101
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Nevada
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Reno, Nevada, Estados Unidos, 89511
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North Carolina
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Burlington, North Carolina, Estados Unidos, 27215
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Greensboro, North Carolina, Estados Unidos, 27408
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Morganton, North Carolina, Estados Unidos, 28655
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Tabor City, North Carolina, Estados Unidos, 28463
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Pennsylvania
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Johnstown, Pennsylvania, Estados Unidos, 15905
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Levittown, Pennsylvania, Estados Unidos, 19056
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29412
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Tennessee
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Kingsport, Tennessee, Estados Unidos, 37660
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Texas
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Dallas, Texas, Estados Unidos, 75235
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Fort Worth, Texas, Estados Unidos, 76104
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Georgetown, Texas, Estados Unidos, 78626
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Houston, Texas, Estados Unidos, 77074
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Plano, Texas, Estados Unidos, 75023
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Virginia
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Alexandria, Virginia, Estados Unidos, 22304
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Richmond, Virginia, Estados Unidos, 23219
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Moscow, Federación Rusa, 117997
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Nizhniy Novgorod, Federación Rusa, 603126
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Rostov-On-Don, Federación Rusa, 344022
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Saint Petersburg, Federación Rusa, 194358
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Tomsk, Federación Rusa, 634050
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Vsevolozhsk, Federación Rusa, 188640
- 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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Yaroslavl, Federación Rusa, 150010
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Ahmedabad, India, 380007
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Ahmedabad, Gujarat, India, 380009
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Bangalore, India, 560054
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Belgaum, India, 590001
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Hyderabaad, India, 500033
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Jaipur, India, 302020
- 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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Kormangala, India, 560034
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Mangalore, India, 575001
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Mumbai, India, 400053
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Mysore, India, 570023
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Nagpur, India, 440025
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New Delhi, India, 110070
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Pune, India, 411035
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Beer Sheva, Israel, 84350
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Beer Yaakov, Israel, 70300
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Dimona, Israel, 68000
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Givataim, Israel, 53488
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Netanya, Israel, 42470
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Petach Tikwa, Israel, 49582
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Rishon Le Zion, Israel, 75650
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Safed, Israel, 13110
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Acquaviva Delle Fonti, Italia, 70021
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Ancona, Italia, 60110
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Foggia, Italia, 71100
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Lucca, Italia, 55100
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Napoli, Italia, 80131
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Parma, Italia, 43100
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Pavia, Italia, 27100
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Rome, Italia, 00168
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San Giovanni Rotondo, Italia, 71013
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Siena, Italia, 53100
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Kanagawa, Japón, 242-0004
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Kanagawa-Ken, Japón, 232-0071
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Aguascalientes, México, 20217
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Durango, México, 34080
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Guadalajara, México, 44680
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Huixquilucan, México, 52763
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Mexico City, México, 11850
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Zapopan, México, 45200
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Ankara, Pavo, 6560
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Canakkale, Pavo, 06310
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Diyarbakir, Pavo, 21280
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Gaziantep, Pavo, 27310
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Istanbul, Pavo, 34865
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Izmir, Pavo
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Kahramanmaras, Pavo, 46050
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Kirikkale, Pavo, 71450
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Beijing, Porcelana, 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, Porcelana, 130041
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Chongqing, Porcelana
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Guang Zhou, Porcelana, 510080
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Shijiazhuang, Porcelana, 50000
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Xi'An, Porcelana, 710061
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Bayamon, Puerto Rico, 00956
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Carolina, Puerto Rico, 00983
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Loiza, Puerto Rico, 772
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Rio Grande, Puerto Rico, 00745
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Rio Piedras, Puerto Rico, 00921
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San Juan, Puerto Rico, 00920
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Toa Baja, Puerto Rico, 00949
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Villa Fontana, Puerto Rico, 00983
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Cardiff, Reino Unido, CF5 4AD
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Chesterfield, Reino Unido, S40 4TF
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Avon
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Bath, Avon, Reino Unido, BA2 3HT
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Cornwall
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Torpoint, Cornwall, Reino Unido, PL11 2JW
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Greater Manchester
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Manchester, Greater Manchester, Reino Unido, M20 2RN
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Lancashire
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Bolton, Lancashire, Reino Unido, BL3 6TL
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South Yorkshire
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Doncaster, South Yorkshire, Reino Unido, DN9 1EP
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Warwickshire
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Atherstone, Warwickshire, Reino Unido, CV9 1EU
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West Glamorgan
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Swansea, West Glamorgan, Reino Unido, SA2 8QA
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Wiltshire
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Bradford On Avon, Wiltshire, Reino Unido, BA15 1DQ
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Pacientes con diabetes tipo 2 que acuden a consultas de atención primaria y especializadas en diabetes.
Descripción
Criterios de inclusión:
- Han sido diagnosticados con diabetes tipo 2
- Han presentado dentro del curso normal de atención
- Han estado en su terapia de insulina inicial durante ≥3 meses (con o sin cualquier combinación de medicamentos antidiabéticos aprobados sin insulina)
- No participan simultáneamente en un estudio que incluye un fármaco o procedimiento en investigación al ingresar al estudio
- Han sido plenamente informados y han dado su consentimiento por escrito para el uso de sus datos
- Tener una comprensión suficiente del idioma principal del país de modo que puedan completar los cuestionarios.
- No haber iniciado la terapia de bolo basal (tres inyecciones de insulina a la hora de las comidas)
Criterio de exclusión:
- Ninguno
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Otro
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
---|
Participantes del MOSAICO
Participantes inscritos en el Estudio observacional multinacional que evalúa el uso de insulina (MOSAIc) que tenían datos de tratamiento completos durante el estudio.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Número de participantes con cambio de tratamiento relacionado con la insulina desde la terapia de insulina inicial
Periodo de tiempo: Línea de base hasta 24 meses
|
El modelo de regresión logística multivariable examinó los factores iniciales relacionados con el participante, el médico y el sistema de salud asociados con la ocurrencia de cualquier cambio en la terapia con insulina.
El dominio de discriminación de la Encuesta Interpersonal de Procesos de Atención [IPC] varía de 1 a 5, donde las puntuaciones más altas indican más discriminación y la Escala de angustia de la diabetes varía de 1 a 6, donde las puntuaciones más altas indican más angustia.
|
Línea de base hasta 24 meses
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Número de episodios de hipoglucemia y de hipoglucemia grave
Periodo de tiempo: Línea de base hasta 24 meses
|
La hipoglucemia y los episodios de hipoglucemia grave son autoinformados por todos los participantes con datos completos del tratamiento desde un mes antes de la visita inicial hasta la última visita (24 meses).
Se pidió a los pacientes en cada visita que informaran sobre cualquier hipoglucemia desde su última visita.
En la visita de referencia, se pidió a los participantes su información de hipoglucemia durante el mes anterior a la visita de referencia.
|
Línea de base hasta 24 meses
|
Número de participantes que se adhirieron a la terapia de insulina prescrita durante el estudio (Adherentes al estudio)
Periodo de tiempo: Línea de base hasta 24 meses
|
Los participantes de MOSAIC respondieron a la pregunta: "¿Con qué frecuencia omitió sus inyecciones de insulina durante los últimos 7 días?".
En cada visita, los participantes se definieron como adherentes a la visita si el participante respondía "No fallé ningún tiro" o "Fallé algunos de mis tiros".
Se definió como no adherente a la visita si respondía alguna de las siguientes preguntas: "Fallé la mitad de mis tiros", "Fallé la mayoría de mis tiros" o "Fallé todos mis tiros".
Un participante se define como adherente al estudio si al menos: 4 de cada 5 visitas adherentes.
|
Línea de base hasta 24 meses
|
Número de participantes que lograron su objetivo personalizado de HbA1c al final del estudio
Periodo de tiempo: Línea de base hasta 24 meses
|
Dado que las prácticas de control de la diabetes varían entre los países representados en MOSAIC, una medida más adecuada para alcanzar el objetivo es el objetivo personalizado que se estableció para cada paciente al comienzo del estudio.
|
Línea de base hasta 24 meses
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2011
Finalización primaria (Actual)
1 de septiembre de 2015
Finalización del estudio (Actual)
1 de septiembre de 2015
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2011
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2011
Publicado por primera vez (Estimar)
25 de julio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
25 de febrero de 2020
Última verificación
1 de febrero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14056
- F3Z-MC-B010 (Otro identificador: Eli Lilly and Company)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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Ensayos clínicos sobre Diabetes Mellitus, Tipo 2
-
AstraZenecaAún no reclutando
-
Daewoong Pharmaceutical Co. LTD.Aún no reclutandoDM2 (Diabetes Mellitus Tipo 2)
-
University of ZambiaUniversity Teaching Hospital, Lusaka, ZambiaAún no reclutandoDiabetes Mellitus Tipo 2 Sin Complicaciones
-
Zhongda HospitalReclutamientoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Shanghai Golden Leaf MedTec Co. LtdReclutamientoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Newsoara Biopharma Co., Ltd.ReclutamientoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
Haisco Pharmaceutical Group Co., Ltd.TerminadoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
PegBio Co., Ltd.TerminadoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Oramed, Ltd.IntegriumTerminadoDM2 (Diabetes Mellitus Tipo 2)Estados Unidos