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LY900014 在 1 型糖尿病参与者中的研究 (PRONTO-T1D)

2020年4月17日 更新者：Eli Lilly and Company

LY900014 与赖脯胰岛素与开放标签餐后 LY900014 治疗组联合甘精胰岛素或德谷胰岛素在 1 型糖尿病 PRONTO-T1D 患者中的前瞻性、随机、双盲比较

本研究的主要目的是评估研究药物 LY900014 与赖脯胰岛素（均与甘精胰岛素或德谷胰岛素联合使用）对 1 型糖尿病 (T1D) 成人患者的疗效。

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)

1392

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

  • 俄罗斯联邦
      • Arkhangel'sk、俄罗斯联邦、163045
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      • Kursk、俄罗斯联邦、305014
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      • Moscow、俄罗斯联邦、119435
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      • Moscow、俄罗斯联邦、117036
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      • Moscow、俄罗斯联邦、123182
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      • Saint Petersburg、俄罗斯联邦、195257
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      • Saratov、俄罗斯联邦、410053
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  • 印度
      • Ahmedabad、印度、380015
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      • Hyderabad、印度、500001
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      • Hyderabad、印度、500035
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      • Hyderabad、印度、500072
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      • Indore、印度、452002
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      • Pune、印度、411001
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      • Secunderabad、印度、500033
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      • Visakhapatnam、印度、530002
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  • 台湾
      • Chang-hua、台湾、500
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      • Taichung、台湾、40447
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      • Taichung、台湾、40201
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      • Tainan、台湾、704
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      • Taipei、台湾、10507
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      • Yongkang、台湾、71004
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  • 墨西哥
      • Guadalajara、墨西哥、44650
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      • Monterrey、墨西哥、64460
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      • Monterrey、墨西哥、64710
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      • Zapopan、墨西哥、45116
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  • 奥地利
      • Graz、奥地利、8036
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      • Graz、奥地利、1060
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      • Wien、奥地利、1030
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  • 巴西
      • São Paulo、巴西、01244-030
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  • 希腊
      • Ampelókipoi、希腊、11527
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      • Athens、希腊、11527
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      • Athens、希腊、17562
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      • Lárisa、希腊、41110
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      • Thessaloníki、希腊、54642
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      • Thessaloníki、希腊、54645
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      • Thessaloníki、希腊、57010
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      • Thérmi、希腊、57001
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  • 德国
      • Bad Mergentheim、德国、97980
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      • Falkensee、德国、14612
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      • Hamburg、德国、22607
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      • Hessen、德国、35415
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      • Magdeburg、德国、39112
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      • Mayen、德国、56727
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      • Münster、德国、48145
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      • Oldenburg、德国、23758
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      • Rheine、德国、67059
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      • Saterland、德国、66386
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  • 意大利
      • Milano、意大利、20132
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      • Ravenna、意大利、48121
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      • Roma、意大利、00161
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      • Siena、意大利、53100
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  • 斯洛伐克
      • Košice、斯洛伐克、04012
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      • Malacky、斯洛伐克、90101
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      • Nové Mesto nad Váhom、斯洛伐克、91501
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      • Rožňava、斯洛伐克、048 01
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  • 新西兰
      • Auckland、新西兰、2025
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      • Christchurch、新西兰、8011
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      • Wellington、新西兰、6021
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    • Auckland
      • Takapuna、Auckland、新西兰、0620
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  • 日本
      • Amagasaki、日本、661
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      • Fukuoka、日本、815-0071
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      • Fukuoka、日本、815-8555
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      • Kamakura、日本、247-0056
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      • Kanagawa、日本、235-0045
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      • Kumamoto、日本、862-0976
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      • Miyazaki、日本、880-0034
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      • Naka、日本、311-0113
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      • Sapporo、日本、060-0001
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      • Sapporo、日本、060-0062
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      • Sasebo、日本、857-1195
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      • Shinjuku、日本、162-8666
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      • Tokyo、日本、1030002
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      • Tokyo、日本、143-0015
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      • Tokyo、日本、160 0022
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      • Tokyo、日本、206-0033
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      • Ōita、日本、870-0039
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      • Ōsaka、日本、545-8586
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      • Ōsaka、日本、569-1096
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  • 波兰
      • Gdańsk、波兰、80-546
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      • Kraków、波兰、31-500
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      • Lublin、波兰、20-333
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      • Lublin、波兰、20-538
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      • Ruda Śląska、波兰、41-709
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      • Szczecin、波兰、70-376
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      • Szczecin、波兰、70-506
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      • Warsaw、波兰、01-518
        • 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.
      • Warszawa、波兰、02-507
        • 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.
      • Wrocław、波兰、50-403
        • 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.
      • Łódź、波兰、90-132
        • 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.
  • 波多黎各
      • Bayamon、波多黎各、00961
        • Advanced Clinical Research, LLC
      • Bayamon、波多黎各、00956
        • Dr Altagracia Aurora Alcantara Gonzalez
      • Manati、波多黎各、00674
        • Manati Center for Clinical Research Inc
      • San Juan、波多黎各、00921
        • Martha Gomez Cuellar M.D.
      • Yabucoa、波多黎各、00767
        • Centro de Endocrinologia del Este
  • 澳大利亚
      • Box Hill、澳大利亚、3128
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Geelong、澳大利亚、3220
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Merewether、澳大利亚、2291
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Oaklands Park、澳大利亚、5046
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
  • 瑞典
      • Göteborg、瑞典、41345
        • 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.
      • Linköping、瑞典、581 85
        • 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.
      • Lund、瑞典、22185
        • 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.
      • Stockholm、瑞典、14186
        • 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.
  • 罗马尼亚
      • Bacău、罗马尼亚、600164
        • 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.
      • Braşov、罗马尼亚、500283
        • 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.
      • Bucuresti、罗马尼亚、013682
        • 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.
      • Lasi、罗马尼亚、700547
        • 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.
      • Oradea、罗马尼亚、410025
        • 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.
      • Ploieşti、罗马尼亚、100163
        • 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.
      • Ploieşti、罗马尼亚、100342
        • 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.
      • Satu Mare、罗马尼亚、440055
        • 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.
      • Timişoara、罗马尼亚、300456
        • 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.
      • Târgu-Mureş、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
      • Mobile、Alabama、美国、36608
        • Internal Medicine Center LLC
    • California
      • Concord、California、美国、94520
        • John Muir Physician Network Clinical Research Center
      • Escondido、California、美国、92025
        • AMCR Institute Inc
      • Fresno、California、美国、93720
        • Valley Endocrine, Fresno
      • Greenbrae、California、美国、94904
        • Marin Endocrine Associates
      • La Mesa、California、美国、91942
        • Diabetes and Endocrine Associates
      • Tustin、California、美国、92780
        • University Clinical Investigators, Inc.
      • Ventura、California、美国、93003
        • Coastal Metabolic Research Centre
    • Colorado
      • Aurora、Colorado、美国、80045
        • Barbara Davis Center for Childhood Diabetes
    • Florida
      • Fort Lauderdale、Florida、美国、33312
        • The Center For Diabetes & Endocrine Care
      • Jacksonville、Florida、美国、32204
        • East Coast Institute for Research
      • New Port Richey、Florida、美国、34652
        • Sun Coast Clinical Research, Inc
      • West Palm Beach、Florida、美国、33401
        • Metabolic Research Institute Inc.
    • Georgia
      • Atlanta、Georgia、美国、30318
        • Atlanta Diabetes Associates
      • Macon、Georgia、美国、31210
        • East Coast Institute for Research
      • Roswell、Georgia、美国、30076
        • Endocrine Research Solutions, Inc.
    • Hawaii
      • Honolulu、Hawaii、美国、96814
        • East West Medical Institute
    • Idaho
      • Boise、Idaho、美国、83704
        • Northwest Clinical Trials
      • Idaho Falls、Idaho、美国、83404
        • Rocky Mountain Diabetes and Osteoporosis Center
    • Illinois
      • Springfield、Illinois、美国、62711
        • Prairie Education And Research Cooperative
    • Iowa
      • West Des Moines、Iowa、美国、50265
        • Iderc, P.L.C.
    • Kansas
      • Kansas City、Kansas、美国、66160
        • University of Kansas Medical Center
      • Topeka、Kansas、美国、66606
        • Cotton O'Neil Diabetes and Endocrinology Center
    • Kentucky
      • Lexington、Kentucky、美国、40503
        • Kentucky Diabetes Endocrinology Center
    • Massachusetts
      • Waltham、Massachusetts、美国、02453
        • MassResearch
    • Nevada
      • Las Vegas、Nevada、美国、89148
        • Palm Research Center
      • Las Vegas、Nevada、美国、89128
        • Palm Research Center
    • New Hampshire
      • Nashua、New Hampshire、美国、03063
        • Southern New Hampshire Diabetes and Endocrinology
    • New York
      • New York、New York、美国、10016
        • Manhattan Medical Research
    • North Carolina
      • Greenville、North Carolina、美国、27843
        • Physicians East
      • Morehead City、North Carolina、美国、28557
        • Diabetes & Endocrinology Consultants PC
      • Wilmington、North Carolina、美国、28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Mentor、Ohio、美国、44060
        • Your Diabetes Endocrine Nutrition Group PC
    • Pennsylvania
      • Allentown、Pennsylvania、美国、18103
        • Lehigh Valley Hospital
      • Pittsburgh、Pennsylvania、美国、15224
        • Partners in Nephrology & Endocrinology
    • Rhode Island
      • Warwick、Rhode Island、美国、02886
        • Sudir Bansal M.D. Inc.
    • Tennessee
      • Chattanooga、Tennessee、美国、37411
        • University Diabetes and Endocrine Consultants
    • Texas
      • Austin、Texas、美国、78731-4309
        • Texas Diabetes and Endocrinology
      • Dallas、Texas、美国、75230
        • Dallas Diabetes Endocrine Center
      • Round Rock、Texas、美国、78681
        • Texas Diabetes and Endocrinology, P.A.
      • Shavano Park、Texas、美国、78231
        • Consano Clinical Research
    • Utah
      • Bountiful、Utah、美国、84010
        • Progressive Clinical Research
    • Washington
      • Federal Way、Washington、美国、98003
        • Private: Dr. Larry Stonesifer
      • Renton、Washington、美国、98057
        • Rainier Clinical Research Center
  • 西班牙
      • Málaga、西班牙、29006
        • 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.
      • Sevilla、西班牙、41071
        • 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.
      • Sevilla、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.
      • Sevilla、西班牙、41010
        • "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."
      • Teruel、西班牙、44002
        • 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.
    • Barcelona
      • Sabadell、Barcelona、西班牙、08208
        • 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.
    • Valencia
      • Alcira、Valencia、西班牙、46600
        • 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、C1013AAB
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Buenos Aires、阿根廷、C1056ABJ
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Caba、阿根廷、C1179AAB
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Caba、阿根廷、C1180AAX
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Ciudad Autonoma de Buenos Aire、阿根廷、1408
        • 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.
      • Ciudad Autonoma de Buenos Aire、阿根廷、C1128AAF
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Córdoba、阿根廷、5006
        • 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、5000
        • 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、B7600FZN
        • 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、OLDER_ADULT)

接受健康志愿者

不

有资格学习的性别

全部

描述

纳入标准：

  • 筛选前至少患有 T1D 1 年，并且连续使用胰岛素至少 1 年。
  • HbA1c ≥7.0 且≤9.5%。
  • 使用赖脯胰岛素、门冬胰岛素或谷赖胰岛素作为餐时胰岛素。
  • 使用甘精胰岛素、地特胰岛素、德谷胰岛素或中性鱼精蛋白哈格多恩 (NPH) 胰岛素作为基础胰岛素。

排除标准：

  • 在筛选后 90 天内使用过其他抗高血糖药物或疗法（吸入、口服或注射）。
  • 在筛选后的 6 个月内发生过 1 次以上的严重低血糖事件。
  • 在筛选后的 6 个月内因高血糖或糖尿病酮症酸中毒住院超过 1 次。
  • 有临床上显着的胃肠道疾病。

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：平行线
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：LY900014
LY900014 在每餐前 0-2 分钟皮下注射 (SC)，每天一次或两次皮下注射基础甘精胰岛素或每天一次皮下注射德谷胰岛素。 餐前胰岛素剂量根据方案定义的目标进行个体化和滴定。
药品：LY900014
施行SC
其他名称：
  • 超速赖脯
药品：甘精胰岛素
施行SC
药品：德谷胰岛素
施行SC
ACTIVE_COMPARATOR：赖脯胰岛素（优泌乐）
每餐前 0-2 分钟皮下注射赖脯胰岛素，每天一次或两次皮下注射基础甘精胰岛素或每天一次皮下注射德谷胰岛素。 餐前胰岛素剂量根据方案定义的目标进行个体化和滴定。
药品：甘精胰岛素
施行SC
药品：德谷胰岛素
施行SC
药品：赖脯胰岛素
施行SC
其他名称：
  • 优泌乐
实验性的：LY900014 餐后（开放标签）
LY900014 在每餐开始后 20 分钟皮下注射，每天一次或两次皮下注射基础甘精胰岛素或每天一次皮下注射德谷胰岛素。 餐时胰岛素剂量根据方案定义的目标进行个体化和滴定。
药品：LY900014
施行SC
其他名称：
  • 超速赖脯
药品：甘精胰岛素
施行SC
药品：德谷胰岛素
施行SC
实验性的：LY900014 - 最大扩展注册 (MEE)
LY900014 在每餐前 0-2 分钟皮下注射 (SC)，每天一次或两次皮下注射基础甘精胰岛素或每天一次皮下注射德谷胰岛素。 餐前胰岛素剂量根据方案定义的目标进行个体化和滴定。
药品：LY900014
施行SC
其他名称：
  • 超速赖脯
药品：甘精胰岛素
施行SC
药品：德谷胰岛素
施行SC
ACTIVE_COMPARATOR：赖脯胰岛素（优泌乐）-MEE
每餐前 0-2 分钟皮下注射赖脯胰岛素，每天一次或两次皮下注射基础甘精胰岛素或每天一次皮下注射德谷胰岛素。 餐前胰岛素剂量根据方案定义的目标进行个体化和滴定。
药品：甘精胰岛素
施行SC
药品：德谷胰岛素
施行SC
药品：赖脯胰岛素
施行SC
其他名称：
  • 优泌乐
实验性的：LY900014 餐后（开放标签）-MEE
LY900014 在每餐开始后 20 分钟皮下注射，每天一次或两次皮下注射基础甘精胰岛素或每天一次皮下注射德谷胰岛素。 餐时胰岛素剂量根据方案定义的目标进行个体化和滴定。
药品：LY900014
施行SC
其他名称：
  • 超速赖脯
药品：甘精胰岛素
施行SC
药品：德谷胰岛素
施行SC

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
第 26 周时血红蛋白 A1c (HbA1c) 疗效估计相对于基线的变化
大体时间：基线，第 26 周

HbA1c 是血红蛋白 A 的糖基化部分。测量 HbA1c 以确定长时间内的平均血浆葡萄糖浓度。

最小二乘法 (LS) 均值由混合模型重复测量 (MMRM) 模型确定，其中分层（合并国家、基础胰岛素类型、餐时胰岛素剂量计划和 HbA1c 分层）和治疗作为固定效应，基线作为协变量。 疗效估计包括在永久停用研究药物之前可获得基线和至少一项基线后测量时的参与者数据。
基线，第 26 周

次要结果测量

结果测量
措施说明
大体时间
第 26 周混合膳食耐受性测试 (MMTT) 功效评估期间餐后 1 小时血糖 (PPG) 偏移相对于基线的变化
大体时间：基线，第 26 周
使用标准化的 MMTT 来表征施用研究胰岛素后的餐后血糖控制。 在餐后 1 小时时间点测量的血清葡萄糖减去空腹血糖。 MMTT 期间的 1 小时 PPG 偏移使用 ANCOVA 模型，其中分层（汇总的国家/地区、基础胰岛素类型、餐时胰岛素剂量计划和 HbA1c 分层）和治疗作为固定效应，基线作为协变量。 疗效估计包括在永久停用研究药物之前可获得基线和至少一项基线后测量时的参与者数据。
基线，第 26 周
第 26 周 MMTT 疗效评估期间 2 小时 PPG 偏离基线的变化
大体时间：基线，第 26 周
使用标准化的 MMTT 来表征施用研究胰岛素后的餐后血糖控制。 在餐后 2 小时时间点测量的血清葡萄糖减去空腹血糖。 MMTT 期间的 2 小时 PPG 偏移使用 ANCOVA 模型，其中分层（合并的国家/地区、基础胰岛素类型、餐时胰岛素剂量计划和 HbA1c 分层）和治疗作为固定效应，基线作为协变量。 疗效估计包括在永久停用研究药物之前可获得基线和至少一项基线后测量时的参与者数据。
基线，第 26 周
第 26 周严重低血糖发生率
大体时间：至第 26 周的基线
严重低血糖症定义为需要他人协助给予碳水化合物、胰高血糖素或其他复苏措施的事件。 在这些发作期间，参与者的精神状态发生了变化，无法协助自己的护理，或者可能处于半清醒或无意识状态，或者经历昏迷，伴有或不伴有癫痫发作，并且可能需要肠胃外治疗。 定义时期内每 100 年的严重低血糖事件发生率的计算方法是，该时期内严重低血糖事件的总数除以治疗组内所有参与者的累计治疗天数 *36525。
至第 26 周的基线
第 26 周记录的症状性低血糖发生率
大体时间：至第 26 周的基线
有记录的症状性低血糖是一种事件，在此期间，典型的低血糖症状伴有血糖 (BG) <54 mg/dL [3.0 毫摩尔每升 (mmol/L)]。 已记录的症状性低血糖发生率通过负二项式模型估算：发作次数 = 治疗对数（治疗暴露天数/365.25） 作为偏移变量。
至第 26 周的基线
第 26 周时 1,5-脱水葡萄糖醇 (1,5-AG) 相对于基线的变化
大体时间：基线，第 26 周
1,5-脱水葡萄糖醇 (1,5-AG) 是短期血糖控制尤其是餐后高血糖的标志物。 1,5-AG 可准确预测血糖的快速变化，并与血糖波动和餐后血糖密切相关。 使用混合模型重复测量 (MMRM) 计算 LS 平均值，包括治疗的固定类别效应、分层（合并国家、基础胰岛素类型、HbA1c 分层和研究开始时的膳食剂量数）、访视和治疗与访视交互作用，以及基线值的连续、固定协变量。 该分析包括在永久停用研究药物之前收集的数据。
基线，第 26 周
第 26 周时 10 点自我监测血糖 (SMBG) 值相对于基线的变化
大体时间：基线，第 26 周
在禁食、早餐后 1 小时、早餐后 2 小时、午饭前、午饭后 1 小时、午饭后 2 小时、晚饭前、饭后 1 小时测量 SMBG 10 点概况晚餐、晚餐后 2 小时和就寝时间。 使用混合模型重复测量 (MMRM) 分析 LS 均值，包括治疗的固定类别效应、分层（合并国家、基础胰岛素类型、HbA1c 分层和研究开始时的膳食剂量数）、就诊和治疗与就诊交互作用，以及基线值的连续、固定协变量。 疗效估计包括基线时的参与者数据和永久停用研究药物之前的至少一次基线后测量。
基线，第 26 周
第 26 周时胰岛素剂量相对于基线的变化
大体时间：基线，第 26 周
使用混合模型重复测量 (MMRM) 分析 LS 均值，包括治疗的固定类别效应、分层（合并国家、基础胰岛素类型、HbA1c 分层和研究开始时的膳食剂量数）、就诊和治疗与就诊交互作用，以及基线值的连续、固定协变量。 分析包括永久停用研究药物之前的数据。
基线，第 26 周
第 26 周时胰岛素治疗满意度问卷 (ITSQ) 方案不便领域评分相对于基线的变化
大体时间：基线，第 26 周
ITSQ 是一种经过验证的工具，包含 22 个项目，用于评估糖尿病患者和使用胰岛素的参与者的治疗满意度。 该问卷从以下 5 个方面衡量满意度：养生法的不便性、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 0-100，其中较高的分数表示较好的治疗满意度。 LS 均值使用 ANCOVA 模型计算，分层（汇总国家、基础胰岛素类型、研究开始时的膳食剂量数和 HbA1c 分层），治疗作为固定效应，基线作为协变量。 分析包括永久停用研究药物之前的数据。 分析包括永久停用研究药物之前的数据。
基线，第 26 周
第 26 周时 ITSQ 生活方式灵活性领域得分相对于基线的变化
大体时间：基线，第 26 周
ITSQ 是一种经过验证的工具，包含 22 个项目，用于评估糖尿病患者和使用胰岛素的参与者的治疗满意度。 该问卷从以下 5 个方面衡量满意度：养生法的不便性、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 0-100，其中较高的分数表示较好的治疗满意度。 LS 均值是使用层协方差分析 (ANCOVA) 计算的（合并国家、基础胰岛素类型、研究开始时的膳食剂量数和 HbA1c 层），治疗作为固定效应，基线作为协变量。 分析包括永久停用研究药物之前的数据。 分析包括永久停用研究药物之前的数据。
基线，第 26 周
HbA1c <7% 的参与者百分比
大体时间：第 26 周
血红蛋白 A1c (HbA1c) 是血红蛋白 A 的糖基化部分。测量 HbA1c 以确定长时间内的平均血浆葡萄糖浓度。
第 26 周
第 52 周时 HbA1c 相对于基线的变化
大体时间：基线，第 52 周

HbA1c 是血红蛋白 A 的糖基化部分。测量 HbA1c 以确定长时间内的平均血浆葡萄糖浓度。

最小二乘法 (LS) 平均值由 MMRM 模型确定，其中变量包括基线、合并国家、导入期间的基础胰岛素类型、餐时胰岛素给药计划、治疗（III 型平方和）作为固定因素。 分析包括永久停用研究药物之前的数据。
基线，第 52 周

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Eli Lilly and Company

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研究记录日期

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研究主要日期

学习开始 (实际的)

2017年7月17日

初级完成 (实际的)

2018年9月6日

研究完成 (实际的)

2019年8月22日

研究注册日期

首次提交

2017年7月10日

首先提交符合 QC 标准的

2017年7月10日

首次发布 (实际的)

2017年7月11日

研究记录更新

最后更新发布 (实际的)

2020年5月1日

上次提交的符合 QC 标准的更新

2020年4月17日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 16313
  • I8B-MC-ITRM (其他：Eli Lilly and Company)
  • 2015-005356-99 (EUDRACT_NUMBER 个)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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IPD 共享访问标准

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IPD 共享支持信息类型

  • 研究方案
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药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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