- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01400971
En observationsundersøgelse for at forstå udfordringer forbundet med progression af insulinterapi ved type 2-diabetes (MOSAIc)
25. februar 2020 opdateret af: Eli Lilly and Company
En multinational observationsundersøgelse, der vurderer insulinbrug: Forståelse af udfordringerne forbundet med terapiens fremskridt - MOSAIc Type 2-diabetesundersøgelsen
Formålet med denne undersøgelse er at identificere specifikke patient-, læge- og sundhedssystemrelaterede faktorer forbundet med progression til et mere intensivt regime fra initial insulinbehandling til patienter med type 2-diabetes.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
4299
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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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, Brasilien, 83430-000
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Caxias Do Sul, Brasilien, 95070560
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Fortaleza, Brasilien, 60430-370
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Santa Maria, Brasilien, 97015-530
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Setor Oeste/Goiania, Brasilien, 74100-120
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São Paulo, Brasilien, 04020-041
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Tatui, Brasilien, 18270-170
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Alberta
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Edmonton, Alberta, Canada, T5A 4L8
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Spruce Grove, Alberta, Canada, T7X 2V2
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
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Newfoundland and Labrador
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St. John'S, Newfoundland and Labrador, Canada, A1A3R5
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Ontario
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Burlington, Ontario, Canada, L7M 4Y1
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London, Ontario, Canada, N6A 5G6
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Smiths Falls, Ontario, Canada, K7A 4W8
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Quebec
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Gatineau, Quebec, Canada, J8V 2P5
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Montreal, Quebec, Canada, H3N 1S4
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Sherbrooke, Quebec, Canada, J1G 1B8
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Moscow, Den Russiske Føderation, 117997
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Nizhniy Novgorod, Den Russiske Føderation, 603126
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Rostov-On-Don, Den Russiske Føderation, 344022
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Saint Petersburg, Den Russiske Føderation, 194358
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Tomsk, Den Russiske Føderation, 634050
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Vsevolozhsk, Den Russiske Føderation, 188640
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Yaroslavl, Den Russiske Føderation, 150010
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Cardiff, Det Forenede Kongerige, CF5 4AD
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Chesterfield, Det Forenede Kongerige, S40 4TF
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Avon
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Bath, Avon, Det Forenede Kongerige, BA2 3HT
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Cornwall
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Torpoint, Cornwall, Det Forenede Kongerige, PL11 2JW
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Greater Manchester
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Manchester, Greater Manchester, Det Forenede Kongerige, M20 2RN
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Lancashire
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Bolton, Lancashire, Det Forenede Kongerige, BL3 6TL
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South Yorkshire
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Doncaster, South Yorkshire, Det Forenede Kongerige, DN9 1EP
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Warwickshire
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Atherstone, Warwickshire, Det Forenede Kongerige, CV9 1EU
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West Glamorgan
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Swansea, West Glamorgan, Det Forenede Kongerige, SA2 8QA
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Wiltshire
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Bradford On Avon, Wiltshire, Det Forenede Kongerige, BA15 1DQ
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Abu Dhabi, Forenede Arabiske Emirater
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Al Ain, Forenede Arabiske Emirater
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Dubai, Forenede Arabiske Emirater, 9115
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Sharjah, Forenede Arabiske Emirater
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72204
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Florida
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Orlando, Florida, Forenede Stater, 32806
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Wellington, Florida, Forenede Stater, 33414
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Georgia
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Canton, Georgia, Forenede Stater, 30114
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Illinois
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Crystal Lake, Illinois, Forenede Stater, 60012
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Nebraska
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North Platte, Nebraska, Forenede Stater, 69101
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Nevada
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Reno, Nevada, Forenede Stater, 89511
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North Carolina
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Burlington, North Carolina, Forenede Stater, 27215
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Greensboro, North Carolina, Forenede Stater, 27408
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Morganton, North Carolina, Forenede Stater, 28655
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Tabor City, North Carolina, Forenede Stater, 28463
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Pennsylvania
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Johnstown, Pennsylvania, Forenede Stater, 15905
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Levittown, Pennsylvania, Forenede Stater, 19056
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29412
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Tennessee
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Kingsport, Tennessee, Forenede Stater, 37660
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Texas
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Dallas, Texas, Forenede Stater, 75235
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Fort Worth, Texas, Forenede Stater, 76104
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Georgetown, Texas, Forenede Stater, 78626
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Houston, Texas, Forenede Stater, 77074
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Plano, Texas, Forenede Stater, 75023
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Virginia
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Alexandria, Virginia, Forenede Stater, 22304
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Richmond, Virginia, Forenede Stater, 23219
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Ahmedabad, Indien, 380007
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Ahmedabad, Gujarat, Indien, 380009
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Bangalore, Indien, 560054
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Belgaum, Indien, 590001
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Hyderabaad, Indien, 500033
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Jaipur, Indien, 302020
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Kormangala, Indien, 560034
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Mangalore, Indien, 575001
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Mumbai, Indien, 400053
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Mysore, Indien, 570023
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Nagpur, Indien, 440025
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New Delhi, Indien, 110070
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Pune, Indien, 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, Italien, 70021
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Ancona, Italien, 60110
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Foggia, Italien, 71100
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Lucca, Italien, 55100
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Napoli, Italien, 80131
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Parma, Italien, 43100
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Pavia, Italien, 27100
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Rome, Italien, 00168
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San Giovanni Rotondo, Italien, 71013
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Siena, Italien, 53100
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Kanagawa, Japan, 242-0004
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Kanagawa-Ken, Japan, 232-0071
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Ankara, Kalkun, 6560
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Canakkale, Kalkun, 06310
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Diyarbakir, Kalkun, 21280
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Gaziantep, Kalkun, 27310
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Istanbul, Kalkun, 34865
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Izmir, Kalkun
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Kahramanmaras, Kalkun, 46050
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Kirikkale, Kalkun, 71450
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Beijing, Kina, 100101
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Changchun City, Kina, 130041
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Chongqing, Kina
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Guang Zhou, Kina, 510080
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Shijiazhuang, Kina, 50000
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Xi'An, Kina, 710061
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Daegu, Korea, Republikken, 705-717
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Daejeon, Korea, Republikken, 301-721
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Gangwon-Do, Korea, Republikken, 200-722
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Goyang-Si, Korea, Republikken, 412-270
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Jeju Special Self-Governing Pr, Korea, Republikken, 690-767
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Sungnam-Si, Korea, Republikken, 463-712
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Aguascalientes, Mexico, 20217
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Durango, Mexico, 34080
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Guadalajara, Mexico, 44680
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Huixquilucan, Mexico, 52763
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Mexico City, Mexico, 11850
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Zapopan, Mexico, 45200
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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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Dammam, Saudi Arabien, 31412
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Makkah, Saudi Arabien, 21955
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Riyadh, Saudi Arabien, 245
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Taif, Saudi Arabien, 21944
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Barcelona, Spanien, 8025
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Gerena, Spanien
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La Roca Del Valles, Spanien, 8430
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Madrid, Spanien, 28034
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Sevilla, Spanien, 41009
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Vic, Spanien, 08500
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Bosenheim, Tyskland, 55545
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Dresden, Tyskland, 01307
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Essen, Tyskland, 45359
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Hamburg, Tyskland, 22415
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Hohenmölsen, Tyskland, 06679
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Kamp-Lintfort, Tyskland, 47475
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Köln, Tyskland, 51069
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Lambrecht, Tyskland, 67466
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Schramberg, Tyskland, 78713
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Speyer, Tyskland, 67346
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patienter med type 2-diabetes, der går i primærpleje og diabetesspecialklinikker.
Beskrivelse
Inklusionskriterier:
- Har fået konstateret type 2 diabetes
- Har præsenteret inden for det normale plejeforløb
- Har været i deres indledende insulinbehandling i ≥3 måneder (med eller uden nogen kombination af godkendte ikke-insulin anti-diabetiske medicin)
- Deltager ikke samtidigt i en undersøgelse, der omfatter et forsøgslægemiddel eller en procedure ved indtræden i undersøgelsen
- Er blevet fuldt informeret og har givet skriftligt samtykke til brugen af deres data
- Har en tilstrækkelig forståelse af landets primære sprog, således at de vil være i stand til at udfylde spørgeskemaerne
- Har ikke påbegyndt basal bolusbehandling (tre måltidsinsulininjektioner)
Ekskluderingskriterier:
- Ingen
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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MOSAI-deltagere
Deltagerne tilmeldte sig et multinationalt observationsstudie, der vurderer insulinbrug (MOSAIc), og som havde fuldstændige behandlingsdata under undersøgelsen.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Antal deltagere med insulinrelateret behandlingsændring fra initial insulinbehandling
Tidsramme: Baseline gennem 24 måneder
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Multivariabel logistisk regressionsmodel undersøgte baseline deltager-, læge- og sundhedssystem-relaterede faktorer forbundet med forekomsten af enhver ændring i insulinbehandling.
Diskriminationsdomænet i Interpersonal Processes of Care Survey [IPC] spænder fra 1-5 med højere score, der indikerer mere diskrimination, og Diabetes Distress Scale varierer fra 1-6 med højere score, der indikerer mere nød.
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Baseline gennem 24 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Antal hypoglykæmiske og alvorlige hypoglykæmiske episoder
Tidsramme: Baseline gennem 24 måneder
|
Hypoglykæmi og alvorlige hypoglykæmiepisoder er selvrapporteret af alle deltagere med fuldstændige behandlingsdata fra en måned før baselinebesøget indtil det sidste besøg (24 måneder).
Patienterne blev ved hvert besøg bedt om selv at rapportere enhver hypoglykæmi siden deres sidste besøg.
Ved baseline-besøget blev deltagerne spurgt om deres hypoglykæmioplysninger for måneden forud for baseline-besøget.
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Baseline gennem 24 måneder
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Antal deltagere, der følger ordineret insulinterapi under undersøgelsen (tilhænger af undersøgelsen)
Tidsramme: Baseline gennem 24 måneder
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MOSAIC-deltagere besvarede spørgsmålet: "Hvor ofte gik du glip af dine insulinsprøjter i løbet af de sidste 7 dage?".
Ved hvert besøg blev deltagerne defineret som besøgstilhængere, hvis deltageren svarede "Jeg missede ingen skud" eller "Jeg missede nogle af mine skud".
De blev defineret som ikke besøgstilhængere, hvis han/hun svarede på et af følgende: "Jeg missede omkring halvdelen af mine skud", "Jeg missede de fleste af mine skud", eller "Jeg missede alle mine skud".
En deltager er defineret som studietilhænger, hvis mindst: 4 ud af 5 besøger.
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Baseline gennem 24 måneder
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Antal deltagere, der nåede deres personlige HbA1c-mål ved afslutningen af undersøgelsen
Tidsramme: Baseline gennem 24 måneder
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Da diabetesbehandlingspraksis varierer på tværs af de lande, der er repræsenteret i MOSAIC, er et mere passende mål for at nå målet det personlige mål, der blev sat for hver patient i begyndelsen af undersøgelsen.
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Baseline gennem 24 måneder
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2011
Primær færdiggørelse (Faktiske)
1. september 2015
Studieafslutning (Faktiske)
1. september 2015
Datoer for studieregistrering
Først indsendt
21. juli 2011
Først indsendt, der opfyldte QC-kriterier
21. juli 2011
Først opslået (Skøn)
25. juli 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14056
- F3Z-MC-B010 (Anden identifikator: Eli Lilly and Company)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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