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一项针对 2 型糖尿病患者的研究 (IMAGINE 2)

2018年3月16日 更新者：Eli Lilly and Company

LY2605541 与甘精胰岛素作为基础胰岛素联合口服抗高血糖药物治疗未接受过胰岛素治疗的 2 型糖尿病患者的比较：一项双盲、随机研究

本研究的目的是：

  • 比较 LY2605541 与甘精胰岛素治疗 52 周后的血糖控制情况。
  • 比较 LY2605541 与甘精胰岛素在 52 周治疗期间的夜间低血糖发作率。
  • 比较接受 LY2605541 治疗 52 周后在夜间无低血糖发作且达到血糖目标的参与者人数与服用甘精胰岛素的参与者人数。
  • 比较 LY2605541 与甘精胰岛素治疗 52 周后的低血糖发作率

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

1538

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 以色列
      • Beer Sheva、以色列、84350
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      • Haifa、以色列、35251
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      • Raanana、以色列、43452
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  • 俄罗斯联邦
      • Cheboksary、俄罗斯联邦、428000
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      • Kazan、俄罗斯联邦、420012
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      • Kursk、俄罗斯联邦、303035
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      • Novosibirsk、俄罗斯联邦、630091
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      • Saint Petersburg、俄罗斯联邦、193257
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  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T5J 3N4
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    • British Columbia
      • Kelowna、British Columbia、加拿大、V1Y 1Z9
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      • Victoria、British Columbia、加拿大、V8V 3N7
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    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3P 3P4
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    • Ontario
      • Etobicoke、Ontario、加拿大、M9R 4E1
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      • Markham、Ontario、加拿大、L6B 0P9
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      • Toronto、Ontario、加拿大、M9W 4L6
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    • Quebec
      • Laval、Quebec、加拿大、H7T 2P5
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      • Pointe-Claire、Quebec、加拿大、H9R 4S3
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      • Sherbrooke、Quebec、加拿大、J1G 5K2
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  • 匈牙利
      • Budapest、匈牙利、H-1139
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      • Debrecen、匈牙利、4032
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      • Mako、匈牙利、6900
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      • Salgotarjan、匈牙利、3100
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      • Sopron、匈牙利、9400
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  • 南非
      • Paarl、南非、7646
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      • Parow、南非、7505
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      • Somerset West、南非、7130
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  • 墨西哥
      • Coatzacoalcos、墨西哥、96400
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      • Mexico City、墨西哥、11550
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      • Monterrey、墨西哥、64620
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  • 巴西
      • Marilia、巴西、17519-000
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      • Rio De Janeiro、巴西、22271-100
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      • Setor Oeste/Goiania、巴西、74100-120
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      • São Paulo、巴西、04266-010
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  • 希腊
      • Ampelokipoi、希腊、11527
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      • Athens、希腊、11527
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      • Thessaloniki、希腊、56429
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  • 德国
      • Dippoldiswalde、德国、01744
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      • Dresden、德国、01307
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      • Friedrichsthal、德国、66299
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      • Furth Im Wald、德国、93437
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      • Goch、德国、47574
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      • Hamburg、德国、D-22587
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      • Ludwigshafen、德国、67059
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      • Münster、德国、48143
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      • Saarbrücken、德国、66121
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      • Schweinfurt、德国、97421
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      • Sulzbach、德国、92237
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  • 意大利
      • Carpi、意大利、41012
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      • Castellanza、意大利、21053
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      • Foggia、意大利、71100
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      • Forli、意大利、47100
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      • Rome、意大利、00133
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      • Sesto San Giovanni、意大利、20099
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  • 斯洛伐克
      • Bratislava、斯洛伐克、82102
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      • Sala、斯洛伐克、92701
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      • Vranov Nad Toplou、斯洛伐克、09301
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  • 新西兰
      • Auckland、新西兰、1640
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  • 波兰
      • Kamieniec Zabkowicki、波兰、57-230
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      • Katowice、波兰、40-772
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      • Krakow、波兰、31-455
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      • Lodz、波兰、93-338
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      • Ruda Slaska、波兰、41-709
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      • Szczecin、波兰、70-506
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      • Tychy、波兰、43-100
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      • Warsaw、波兰、01-192
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  • 波多黎各
      • Hato Rey、波多黎各、00917
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      • Manati、波多黎各、00674
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      • San Juan、波多黎各、00917-3104
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  • 澳大利亚
    • New South Wales
      • Merewether、New South Wales、澳大利亚、2291
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    • South Australia
      • Keswick、South Australia、澳大利亚、5035
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    • Victoria
      • Box Hill、Victoria、澳大利亚、3128
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    • Western Australia
      • Fremantle、Western Australia、澳大利亚、6160
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  • 火鸡
      • Gaziantep、火鸡、27070
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      • Hatay、火鸡、31040
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      • Izmir、火鸡、35340
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      • Kayseri、火鸡、38039
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  • 立陶宛
      • Utena、立陶宛、28151
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      • Vilnius、立陶宛、LT-08661
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  • 罗马尼亚
      • Bucharest、罗马尼亚、011234
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      • Cluj-Napoca、罗马尼亚、400006
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      • Iasi、罗马尼亚、700547
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      • Oradea、罗马尼亚、410169
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      • Ploiesti、罗马尼亚、100342
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      • Resita、罗马尼亚、320076
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      • Targu-Mures、罗马尼亚、540098
        • 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.
  • 美国
    • Alabama
      • Anniston、Alabama、美国、36207
        • 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.
      • Mobile、Alabama、美国、36608
        • 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.
    • Arizona
      • Chandler、Arizona、美国、85224
        • 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.
      • Mesa、Arizona、美国、85206
        • 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.
      • Tempe、Arizona、美国、85283
        • 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.
      • Tucson、Arizona、美国、85704
        • 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.
    • California
      • Concord、California、美国、94520
        • 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.
      • Escondido、California、美国、92026
        • 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.
      • Fresno、California、美国、93720
        • 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.
      • Greenbrae、California、美国、94904
        • 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.
      • Huntington Beach、California、美国、92648
        • 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.
      • Lancaster、California、美国、93534
        • 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.
      • Los Angeles、California、美国、90057
        • 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.
      • Mission Viejo、California、美国、92691
        • 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.
      • Northridge、California、美国、91324
        • 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.
      • Palm Springs、California、美国、92262
        • 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.
      • San Mateo、California、美国、94401
        • 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.
      • Tustin、California、美国、92780
        • 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.
    • Colorado
      • Denver、Colorado、美国、80246
        • 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.
    • Florida
      • Daytona Beach、Florida、美国、32117
        • 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.
      • Jacksonville、Florida、美国、32258
        • 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.
      • Tampa、Florida、美国、33619
        • 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.
      • Winter Haven、Florida、美国、33880
        • 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.
    • Georgia
      • Athens、Georgia、美国、30606
        • 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.
      • Atlanta、Georgia、美国、30338
        • 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.
      • Decatur、Georgia、美国、30033
        • 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.
    • Hawaii
      • Honolulu、Hawaii、美国、96814
        • 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.
    • Idaho
      • Idaho Falls、Idaho、美国、83404
        • 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.
      • Meridian、Idaho、美国、83646
        • 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.
    • Illinois
      • Chicago、Illinois、美国、60607
        • 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.
      • Springfield、Illinois、美国、62704
        • 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.
    • Iowa
      • West Des Moines、Iowa、美国、50266
        • 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.
    • Kansas
      • Topeka、Kansas、美国、66606
        • 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.
    • Louisiana
      • Shreveport、Louisiana、美国、71103
        • 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.
    • Maine
      • Bangor、Maine、美国、04401
        • 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.
    • Massachusetts
      • Haverhill、Massachusetts、美国、01830
        • 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.
    • Missouri
      • Saint Louis、Missouri、美国、63141
        • 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.
    • Montana
      • Billings、Montana、美国、59102
        • 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.
    • New Hampshire
      • Nashua、New Hampshire、美国、03063
        • 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.
    • New Jersey
      • Toms River、New Jersey、美国、08753
        • 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.
    • Ohio
      • Cincinnati、Ohio、美国、45236
        • 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.
      • Gallipolis、Ohio、美国、45631
        • 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.
      • Perrysburg、Ohio、美国、43551
        • 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.
    • Oregon
      • Corvallis、Oregon、美国、97330
        • 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.
      • Springfield、Oregon、美国、97477
        • 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.
    • Pennsylvania
      • Beaver、Pennsylvania、美国、15009
        • 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.
      • Downingtown、Pennsylvania、美国、19335
        • 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.
      • Lansdale、Pennsylvania、美国、19446
        • 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.
      • Levittown、Pennsylvania、美国、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.
      • Philadelphia、Pennsylvania、美国、19107
        • 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.
      • Pottstown、Pennsylvania、美国、19464
        • 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.
    • South Carolina
      • Greer、South Carolina、美国、29651
        • 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.
      • Myrtle Beach、South Carolina、美国、29572
        • 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.
    • Tennessee
      • Bristol、Tennessee、美国、37620
        • 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.
      • Knoxville、Tennessee、美国、37912
        • 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.
      • Memphis、Tennessee、美国、38119
        • 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.
      • Spring Hill、Tennessee、美国、37174
        • 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.
    • Texas
      • Austin、Texas、美国、78758
        • 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.
      • Marshall、Texas、美国、75670
        • 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.
      • Sugar Land、Texas、美国、77478
        • 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.
    • Utah
      • Bountiful、Utah、美国、84010
        • 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.
      • Clinton、Utah、美国、84015
        • 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.
      • Ogden、Utah、美国、84403
        • 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.
    • Washington
      • Olympia、Washington、美国、98502
        • 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.
      • Port Orchard、Washington、美国、98366
        • 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.
      • Spokane、Washington、美国、99220
        • 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.
  • 芬兰
      • Oulu、芬兰、90100
        • 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.
      • Seinajoki、芬兰、60220
        • 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.
  • 英国
    • Berks
      • Mortimer、Berks、英国、RG7 3SQ
        • 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.
    • Leicestershire
      • Leicester、Leicestershire、英国、LE5 4PW
        • 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.
    • Surrey
      • Guildford、Surrey、英国、GU2 7XX
        • 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.
    • Wales
      • Swansea、Wales、英国、SA6 6NL
        • 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.
  • 西班牙
      • Alicante、西班牙、03114
        • 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.
      • Cordoba、西班牙、14004
        • 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.
      • Pozuelo De Alarcon、西班牙、28223
        • 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.
      • Requena、西班牙、46340
        • 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.
      • Seville、西班牙、41003
        • 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.
      • Toledo、西班牙、45004
        • 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.
  • 阿根廷
      • Buenos Aires、阿根廷、C1188AAF
        • 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.
      • Caba、阿根廷、2000
        • 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.
      • Córdoba、阿根廷、X5000BNB
        • 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.
      • Mar Del Plata、阿根廷、B7600GNY
        • 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.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

纳入标准：

  • 在研究前至少 1 年患有 2 型糖尿病，未接受胰岛素治疗
  • 在进入研究之前至少 3 个月内至少接受过 2 次 OAM
  • 筛查时血红蛋白 A1c (HbA1c) 值介于 7.0% 和 11.0% 之间
  • 能够并愿意使用小瓶和注射器注射胰岛素并进行自我血糖监测
  • 仅具有生育潜力的女性：未进行母乳喂养，在筛查和随机分组时妊娠试验呈阴性，不打算在试验期间怀孕，在筛查前至少 6 周采用可靠的避孕方法，并且同意在研究期间和最后一剂研究药物后 2 周内使用可靠的避孕方法

排除标准：

  • 在过去 2 年内的任何时间使用过胰岛素治疗（妊娠以外），急性病症的短期治疗除外，最多连续 4 周
  • 同时或在筛选前 3 个月内使用罗格列酮、普兰林肽或胰高血糖素样肽 1 (GLP-1) 受体激动剂（例如艾塞那肽、每周一次的艾塞那肽或利拉鲁肽）
  • 目前正在服用或在筛选前 3 个月内服用过促进减肥的药物
  • 筛选前 6 个月内有过任何严重低血糖发作
  • 研究前 6 个月内有 1 次或多次酮症酸中毒或高渗状态/昏迷
  • 患有功能状态为纽约心脏协会 III 级或 IV 级的心脏病（根据纽约心脏协会 [NYHA] 心脏病分类）
  • 有肾移植史，或目前正在接受肾透析或血清肌酐大于或等于 2 毫克每分升 (mg/dL)
  • 在筛选时有明显的肝病临床体征或症状（不包括非酒精性脂肪肝 [NAFLD]）、急性或慢性肝炎、非酒精性脂肪性肝炎 (NASH) 或肝酶测量值升高
  • 在筛选前 3 个月内有过输血或严重失血，或有已知的血红蛋白病、溶血性贫血或镰状细胞性贫血，或任何其他已知会干扰 HbA1c 测量的血红蛋白异常特征
  • 患有活动性或未治疗的恶性肿瘤，或者临床上显着的恶性肿瘤缓解期不到 5 年
  • 筛选时空腹或非空腹甘油三酯大于 400 mg/dL（大于 4.5 毫摩尔每升 [mmol/L]）
  • 在筛选前 90 天内使用剂量不稳定的降脂药物
  • 在筛选前 90 天内使用烟酸制剂作为降脂药物和胆汁酸螯合剂

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：LY2605541
LY2605541 根据血糖读数进行滴定，皮下给药 (SC)，每天一次，与私人医生处方的至少 2 种研究前口服降糖药 (OAM) 联合使用，持续 52 或 78 周
药品：LY2605541
有源比较器：甘精胰岛素
甘精胰岛素根据血糖读数滴定，皮下给药，每天一次，结合私人医生规定的至少 2 种研究前 OAM，持续 52 或 78 周
药品：甘精胰岛素

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
糖化血红蛋白 (HbA1c) 从基线到 52 周终点的变化
大体时间：基线，52 周
HbA1C 是一项测量一个人在过去 2 至 3 个月内的平均血糖水平的测试。 使用混合模型重复测量 (MMRM) 和基线 HbA1c 测量、分层因素（国家、低密度脂蛋白胆固醇 [LDL-C，< 100 毫克/分升 {mg/dL} 和 ≥ 100 mg/dL] 和磺酰脲 [SU]/格列奈的使用）、就诊、治疗和就诊与治疗的相互作用作为固定效应。
基线，52 周

次要结果测量

结果测量
措施说明
大体时间
总体和夜间低血糖事件发生率
大体时间：基线至 52 周
低血糖是当一个人的血糖水平低于正常范围（小于或等于 70 毫克每分升 [mg/dL] 或小于 3.9 毫摩尔每升 [mmol/L]）时发生的一种情况。 总低血糖是指符合记录的症状性低血糖、无症状性低血糖、可能的症状性低血糖、未明确的低血糖或严重低血糖标准的事件。 夜间低血糖是指就寝时间和醒来之间发生的任何总低血糖事件。 使用负二项式回归模型（发作次数 = 治疗 + SU/美格列奈使用 + 基线低血糖事件率，log [每 30 天暴露] 作为模型中的偏移变量）。
基线至 52 周
血红蛋白 A1c 等于或小于 6.5% 且小于 7.0% 的参与者百分比
大体时间：52周
参与者百分比的计算方法是将达到目标 HbA1c 的参与者人数除以分析的参与者总数，再乘以 100。
52周
空腹血糖（通过实验室测量）
大体时间：52周
LS 平均值是使用 MMRM 计算的，包括基线空腹血糖测量、分层因素（国家、HbA1c、LDL-C [< 100 mg/dL 和 ≥ 100 mg/dL]，以及 SU/格列奈的使用）、治疗、访视和治疗与访问的交互作用作为固定效应。
52周
空腹血糖（通过参与者自我监测的血糖读数）
大体时间：52周
使用 MMRM 计算 LS 平均值，包括基线空腹血糖测量、分层因素（国家、HbA1c、LDL-C [< 100 mg/dL 和 ≥ 100 mg/dL]，以及 SU/格列奈的使用）、治疗、访视和治疗与访问的交互作用作为固定效应。
52周
6 点自我监测血糖 (SMBG)
大体时间：52周
在早餐前（禁食）、午餐前（午餐）、晚餐前（晚餐）、就寝时间、大约 0300 小时和第二天的早餐前（禁食）获得六点 SMBG 图谱。 在下一次办公室访问之前的一周内，在非连续的 2 天内获得了六点 SMBG 概况。 使用 MMRM 计算 LS 平均值，包括基线血糖测量、分层因素（国家、HbA1c、LDL-C [< 100 mg/dL 和 ≥ 100 mg/dL]，以及 SU/格列奈的使用）、治疗、就诊和治疗-by-visit 交互作为固定效果。
52周
体重从基线到 52 周的变化
大体时间：基线，52 周
使用 MMRM 计算 LS 平均值，包括基线体重测量、分层因素（国家、HbA1c、LDL-C [< 100 mg/dL 和 ≥ 100 mg/dL]，以及 SU/格列奈的使用）、治疗、访视和治疗-by-visit 交互作为固定效果。
基线，52 周
血红蛋白 A1c
大体时间：52周
HbA1c 是一项测量一个人在过去 2 至 3 个月内的平均血糖水平的测试。 LS 平均值是使用 MMRM 计算的，包括基线 HbA1c 测量、分层因素（国家、HbA1c、LDL-C [< 100 mg/dL 和 ≥ 100 mg/dL]，以及 SU/格列奈的使用）、治疗、就诊和治疗-作为固定效应的访问交互。
52周
每体重的胰岛素剂量
大体时间：52周
使用 MMRM 计算 LS 平均值，包括基线胰岛素剂量测量、分层因素（国家、HbA1c、LDL-C [< 100 mg/dL 和 ≥ 100 mg/dL]，以及 SU/格列奈的使用）、治疗、就诊和治疗-by-visit 交互作为固定效果。
52周
胰岛素剂量调整至稳态的次数
大体时间：基线至 52 周
在研究的前 26 周期间，根据算法（改编自 Riddle 等人，2003 年）调整胰岛素剂量，此后根据研究者的判断进行调整。 稳态被定义为 LY2605541 或甘精胰岛素在 +/- 2 周的窗口内的第一个局部最大剂量（移动 4 周间隔的最大值）。 达到稳态的剂量调整次数是达到稳态之前剂量变化的总数。 使用 MMRM 计算 LS 平均值，包括基线胰岛素剂量测量、分层因素（国家、HbA1c、LDL-C [< 100 mg/dL 和 ≥ 100 mg/dL]，以及 SU/格列奈的使用）、治疗、就诊和治疗-by-visit 交互作为固定效果。
基线至 52 周
欧洲生活质量 - 5 维 (EQ-5D)
大体时间：52周
EQ-5D 是一种通用的、多维的、与健康相关的生活质量仪器。 该概况允许参与者使用 1 到 3 的 3 级量表（没问题、有些问题、和极端问题）。 根据美国基于人口的算法，这些属性组合被转换为加权健康状态指数得分。 分数范围从 -0.11 到 1.0，其中 1.0 表示完美健康。 LS 均值使用 MMRM 计算，基线分层因素（国家、HbA1c 和 SU/格列奈使用）、治疗、访视和治疗与访视交互作用作为固定效应。
52周
胰岛素治疗满意度问卷
大体时间：长达 52 周
胰岛素治疗满意度问卷 (ITSQ) 是一种经过验证的工具，包含 22 个项目，用于评估接受胰岛素治疗的糖尿病患者的治疗满意度。 该问卷从以下 5 个方面衡量满意度：方案的不便、生活方式的灵活性、血糖控制、低血糖控制和胰岛素输送装置。 呈现的数据是转换后的总分，评分范围为 0 到 100，其中较高的分数表示较好的治疗满意度。 LS 平均值是使用 MMRM 计算的，分层因素（国家、HbA1c 和 SU/格列奈使用）、治疗、就诊和治疗与就诊交互作用作为固定效应。
长达 52 周
成人低血糖调查
大体时间：长达 52 周
成人低血糖调查 (LBSS) 是一份经过验证的、由参与者报告的 33 项问卷，其中的项目按照 5 分李克特量表进行评分，其中 0 = 从不，4 = 总是。 LBSS 测量避免低血糖及其负面后果的行为（15 项）和对低血糖及其负面后果的担忧（18 项）。 总分是所有项目的总和（范围为 0 到 132）。 较高的总分反映了对低血糖的更大恐惧。 使用基线 LBSS 评分、分层因素（国家、HbA1c 和 SU/格列奈使用）和治疗作为固定效应的协方差模型 (ANCOVA) 分析计算 LS 均值。
长达 52 周
甘油三酯、低密度脂蛋白胆固醇 (LDL-C) 和高密度脂蛋白胆固醇 (HDL-C) 从基线到 52 周的变化
大体时间：基线，52 周
LS 平均值是使用 MMRM 计算的，包括基线脂质测量、分层因素（国家、HbA1c、LDL-C [< 100 mg/dL 和 ≥ 100 mg/dL]，以及 SU/格列奈的使用）、治疗、就诊和治疗-访问交互作为固定效应。
基线，52 周
总胆红素等于或高于正常上限 (ULN) 2 倍和 3 倍的参与者百分比
大体时间：长达 52 周
长达 52 周
整体治疗紧急抗 LY2065541 抗体反应 (撕裂)
大体时间：基线至 78 周
总结了具有 TEAR 的参与者的百分比。 撕裂定义为抗 LY2605541 抗体水平从基线时检测不到到基线时可检测到的变化，或者对于那些在基线时具有可检测抗体的参与者，变化到与基线相比至少相对增加 130% 的值。 总体 TEAR 定义为特定时期内的一次或多次 TEAR。
基线至 78 周
空腹血糖 (FBG) 的参与者内部变异性
大体时间：52周
FBG 的参与者内部变异性由 SMBG 测量，通过第 52 周访视时 FBG 测量值的标准差进行评估。 使用 MMRM 计算 LS 平均值，包括基线空腹血糖测量、分层因素（国家、HbA1c、LDL-C [< 100 mg/dL 和 ≥ 100 mg/dL]，以及 SU/格列奈的使用）、治疗、访视和治疗与访问的交互作用作为固定效应。
52周
总和夜间低血糖事件参与者的百分比
大体时间：基线至 52 周
低血糖事件定义为血糖值≤70 mg/dL (3.9mmol/L)。 总低血糖事件包括有记录的症状性低血糖、无症状性低血糖、可能的症状性低血糖、未明确的低血糖或严重的低血糖。 夜间低血糖事件是指就寝时间和醒来之间发生的任何总低血糖事件。 参与者百分比的计算方法是将发生低血糖或夜间低血糖事件的参与者人数除以所分析的参与者总数，再乘以 100。
基线至 52 周
HbA1C 等于或小于 6.5% 且小于 7.0% 且无夜间低血糖的参与者百分比
大体时间：长达 52 周
显示了 HbA1C ≤ 6.5% 或 < 7.0% 且无夜间低血糖的参与者百分比。 百分比的计算方法是将具有指定 HbA1c 值的参与者人数除以参与者总数，然后乘以 100。
长达 52 周
丙氨酸转氨酶/血清谷氨酸丙酮酸转氨酶 (ALT/SGPT) 和天冬氨酸转氨酶/血清谷氨酸草酰乙酸转氨酶 (AST/SGOT) 等于或高于 2 倍和 3 倍 ULN 的参与者百分比
大体时间：长达 52 周
参与者百分比的计算方法是将等于或高于 ALT/SGPT 或 AST/SGOT ULN 2 倍或 3 倍的参与者人数除以分析的参与者总数，再乘以 100。
长达 52 周

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年11月1日

初级完成 (实际的)

2014年1月1日

研究完成 (实际的)

2014年1月1日

研究注册日期

首次提交

2011年9月9日

首先提交符合 QC 标准的

2011年9月15日

首次发布 (估计)

2011年9月16日

研究记录更新

最后更新发布 (实际的)

2018年4月13日

上次提交的符合 QC 标准的更新

2018年3月16日

最后验证

2018年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 12141
  • I2R-MC-BIAJ (其他标识符：Eli Lilly and Company)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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