对 I 型糖尿病参与者的研究 (IMAGINE 3)
2018年3月16日 更新者：Eli Lilly and Company
LY2605541 对比甘精胰岛素对餐前胰岛素赖脯胰岛素治疗的 1 型糖尿病患者的影响：一项为期 52 周的双盲随机研究
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 与甘精胰岛素在 52 周治疗期间的低血糖发作率
研究概览
研究类型
介入性
注册 (实际的)
1114
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
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Kobenhavn、丹麦、2400
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Haifa、以色列、31096
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Jerusalem、以色列、91120
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Petah Tikva、以色列、49100
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Petah Tiqva、以色列、49451
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Tel Hashomer、以色列、52621
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Osijek、克罗地亚、31000
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Alberta
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Edmonton、Alberta、加拿大、T5J 3N4
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Red Deer、Alberta、加拿大、T4N 6V7
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Manitoba
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Winnipeg、Manitoba、加拿大、R3E 3P4
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3H 2Y9
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Ontario
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Oakville、Ontario、加拿大、L6H 3P1
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Quebec
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Laval、Quebec、加拿大、H7T 2P5
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Montreal、Quebec、加拿大、H2W 1T8
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Houghton、南非、2198
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Pretoria、南非、0002
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Somerset West、南非、7130
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Fortaleza、巴西、60430-350
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Porto Alegre、巴西、91350250
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São Paulo、巴西、01244-030
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Athens、希腊、10552
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Chalkida、希腊、341 00
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Thessaloniki、希腊、56429
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Sturovo、斯洛伐克、943 01
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Christchurch、新西兰、8001
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Wellington、新西兰、6021
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Brussels、比利时、1070
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Edegem、比利时、2650
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Huy、比利时、4500
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Sint-Niklaas、比利时、9100
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La Rochelle、法国、17019
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Le Creuzot、法国、71200
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Paris、法国、75022
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Rouen、法国、76031
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Gdansk、波兰、80-546
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Katowice、波兰、40-057
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Krakow、波兰、31-261
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Lubin、波兰、59-300
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Lublin、波兰、20-538
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Szczecin、波兰、70-506
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Warsaw、波兰、02-507
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New South Wales
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Merewether、New South Wales、澳大利亚、2291
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South Australia
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Keswick、South Australia、澳大利亚、5035
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Victoria
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Box Hill、Victoria、澳大利亚、3128
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Parkville、Victoria、澳大利亚、3050
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Dublin、爱尔兰
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Alingsås、瑞典、44183
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Helsingborg、瑞典、25187
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Huddinge、瑞典、14186
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Karlstad、瑞典、SE-651 85
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Jonava、立陶宛、LT-55201
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Kaunas、立陶宛、LT-51270
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California
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Concord、California、美国、94520
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Fresno、California、美国、93720
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La Mesa、California、美国、91942
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Lancaster、California、美国、93534
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Tustin、California、美国、92780
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Colorado
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Aurora、Colorado、美国、80045
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Longmont、Colorado、美国、80501
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Florida
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Bradenton、Florida、美国、34208
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Hollywood、Florida、美国、33021
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Jacksonville、Florida、美国、32258
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New Port Richey、Florida、美国、34652
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West Palm Beach、Florida、美国、33401
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Georgia
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Roswell、Georgia、美国、30076
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Hawaii
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Honolulu、Hawaii、美国、96814
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Idaho
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Idaho Falls、Idaho、美国、83404
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Illinois
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Springfield、Illinois、美国、62704
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Iowa
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Des Moines、Iowa、美国、50314
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Kansas
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Topeka、Kansas、美国、66606
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Wichita、Kansas、美国、67226
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Kentucky
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Lexington、Kentucky、美国、40503
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Louisiana
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Metairie、Louisiana、美国、70006
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Maryland
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Baltimore、Maryland、美国、21204
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Minnesota
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Eagan、Minnesota、美国、55123
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Minneapolis、Minnesota、美国、55416
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Missouri
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Chesterfield、Missouri、美国、63017
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Springfield、Missouri、美国、65807
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Montana
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Billings、Montana、美国、59101
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Nebraska
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Omaha、Nebraska、美国、68114
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Nevada
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Las Vegas、Nevada、美国、89148
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New Hampshire
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Nashua、New Hampshire、美国、03063
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New York
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Albany、New York、美国、12208
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North Carolina
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Durham、North Carolina、美国、27713
- 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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Morehead City、North Carolina、美国、28557
- 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
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Mentor、Ohio、美国、44060
- 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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Oregon
-
Eugene、Oregon、美国、97401
- 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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Portland、Oregon、美国、97210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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-
South Carolina
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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.
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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.
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Tennessee
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Chattanooga、Tennessee、美国、37411
- 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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-
Texas
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Austin、Texas、美国、78731
- 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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Dallas、Texas、美国、75231
- 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.
-
Houston、Texas、美国、77095
- 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.
-
Round Rock、Texas、美国、78681
- 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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Utah
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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.
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Washington
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Federal Way、Washington、美国、98003
- 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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Spokane、Washington、美国、99202
- 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.
-
Tacoma、Washington、美国、98405
- 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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-
-
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Glasgow、英国、G21 3UW
- 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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Northampton、英国、NN1 5BD
- 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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Oxford、英国、OX3 7LJ
- 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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-
Avon
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Bristol、Avon、英国、BS10 5NB
- 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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Hampshire
-
Portsmouth、Hampshire、英国、P06 3LY
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Lancashire
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Blackburn、Lancashire、英国、BB2 3HH
- 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.
-
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Scotland
-
Inverness、Scotland、英国、IV2 3JH
- 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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-
Suffolk
-
Ipswich、Suffolk、英国、IP4 5PD
- 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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Surrey
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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.
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Wales
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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.
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Dordrecht、荷兰、3317 NM
- 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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Groningen、荷兰、9728 NT
- 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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Alcala De Henares、西班牙、28805
- 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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Alcira、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.
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Barcelona、西班牙、08036
- 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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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.
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Sevilla、西班牙、41014
- 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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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.
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Valencia、西班牙、46014
- 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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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：
- 1 型糖尿病至少 1 年
- 根据中心实验室筛选时的 HbA1c 值低于 12%
- 体重指数小于或等于 35.0 千克每平方米 (kg/m^2)
在筛选前已接受至少 90 天的治疗
- 地特胰岛素、甘精胰岛素或中性鱼精蛋白 (NPH) 与餐前胰岛素联合使用，或
- 自混合或预混合胰岛素方案与任何基础和推注胰岛素组合每天至少给药两次，或
- 连续 SC 胰岛素输注治疗
- 未接受母乳喂养且在接受治疗前妊娠检测呈阴性并同意在最后一次使用研究药物治疗后 2 周内使用可靠的避孕措施的女性
- 能够并愿意坚持每天多次注射，使用小瓶、注射器和预装笔进行注射，并进行自我监测血糖 (SMBG) 读数和记录保存
排除标准：
- 正在使用每天两次的甘精胰岛素，在筛选前每天单剂量的甘精胰岛素没有得到充分控制
- 胰岛素抵抗过度定义为在随机化时接受的胰岛素每日总剂量大于 1.5 单位每公斤 (U/kg)
- 在筛查前 90 天内接受任何用于治疗糖尿病的口服或注射药物（用于治疗多囊卵巢疾病的胰岛素或二甲双胍除外）
降脂药物：
- 在筛选前 90 天内使用烟酸制剂作为降脂药物和/或胆汁酸螯合剂；或者，
- 在筛查前 90 天或更长时间内使用剂量不稳定的降脂药物
- 筛选时患有空腹高甘油三酯血症（定义为大于 4.5 毫摩尔/升 [mmol/L]，大于 400 毫克/分升 [mg/dL]），由中心实验室确定。
- 筛选前 6 个月内发生超过 1 次严重低血糖（定义为因神经功能障碍性低血糖而需要帮助）
- 筛选前 6 个月内因血糖控制不佳而有 2 次或更多次急诊室就诊或住院治疗
- 患有功能状态为纽约心脏协会 III 级或 IV 级的心脏病
- 有肾移植史或目前正在接受肾透析或血清肌酐大于 2.5 mg/dL
有明显的肝病临床体征或症状（不包括非酒精性脂肪性肝病 [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，如下所示：
- 总胆红素是中心实验室定义的正常上限 (ULN) 的 2 倍或以上，或
- 丙氨酸转氨酶 (ALT)/(血清谷丙转氨酶 (SGPT) 超过中心实验室定义的 ULN 的 2.5 倍，或
- 天冬氨酸氨基转移酶 (AST)/(血清谷氨酸草酰乙酸转氨酶 (SGOT) 超过中心实验室定义的 ULN 的 2.5 倍
- 患有活动性或未经治疗的恶性肿瘤，已从具有临床意义的恶性肿瘤（基底细胞或鳞状细胞皮肤癌除外）缓解不到 5 年，或者患癌症或癌症复发的风险增加
- 诊断出具有临床意义的糖尿病自主神经病变
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 + 赖脯胰岛素
LY2605541 根据血糖读数进行滴定，与赖脯胰岛素联合使用，每天睡前皮下 (SC) 给药一次，持续 52 周。
根据血糖读数滴定赖脯胰岛素，在进餐时间皮下给药，持续 52 周。
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其他名称：
|
|
有源比较器：甘精胰岛素 + 赖脯胰岛素
甘精胰岛素剂量根据血糖读数滴定，每天睡前皮下注射一次，与赖脯胰岛素联合使用，持续 52 周。
根据血糖读数滴定赖脯胰岛素剂量，在进餐时间皮下给药，持续 52 周。
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其他名称：
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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)
大体时间：52周
|
HbA1c 是一项测量参与者在 2 至 3 个月时间范围内的平均血糖水平的测试。
使用混合模型重复测量 (MMRM) 调整治疗、分层因素（国家、基线低密度脂蛋白胆固醇 [LDL-C] [<100 毫克/分升 (mg/dL)（2.6 毫摩尔/升 [mmol/L]) 和 ≥100 mg/dL (2.6 mmol/L)]、基线之前的基础胰岛素治疗 [甘精胰岛素/地特胰岛素/其他]）、就诊、治疗与就诊相互作用以及基线 HbA1c 作为固定效应和参与者作为随机效应。
|
52周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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糖化血红蛋白 (HbA1c)
大体时间：26周
|
HbA1c 是一项测量参与者在过去 2 至 3 个月内的平均血糖水平的测试。
使用 MMRM 计算 LS 平均值，调整治疗、分层因素（国家、基线 LDL-C [<100 mg/dL (2.6 mmol/L) 和 ≥100 mg/dL (2.6 mmol/L)]、基线之前的基础胰岛素治疗[甘精胰岛素/地特胰岛素/其他])、就诊、治疗-就诊相互作用和基线 HbA1c 作为固定效应，参与者作为随机效应。
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26周
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HbA1c 从基线到 52 周的变化
大体时间：基线，52 周
|
HbA1c 是一项测量参与者在 2 至 3 个月时间范围内的平均血糖水平的测试。
使用 MMRM 计算 LS 平均值，调整治疗、分层因素（国家、基线 LDL-C [<100 mg/dL (2.6 mmol/L) 和 ≥100 mg/dL (2.6 mmol/L)]、基线之前的基础胰岛素治疗[甘精胰岛素/地特胰岛素/其他])、就诊、治疗-就诊相互作用和基线 HbA1c 作为固定效应，参与者作为随机效应。
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基线，52 周
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总低血糖事件
大体时间：基线至 26 周，基线至 52 周
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低血糖发作定义为与报告的低血糖体征和症状和/或记录的血糖 (BG) 浓度≤70 mg/dL (3.9 mmol/L) 相关的事件。
给出了组平均总低血糖率（每 30 天），并根据负二项式回归模型计算（发作次数 = 治疗 + 基线总低血糖率，log [暴露天数/30] 作为偏移变量）。
组均值是通过首先对单个参与者协变量取反向链接函数然后对所有参与者取平均值来估计的。
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基线至 26 周，基线至 52 周
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总低血糖事件参与者的百分比
大体时间：基线至 26 周，基线至 52 周
|
低血糖发作定义为与报告的低血糖体征和症状和/或记录的 BG 浓度≤70 mg/dL (3.9 mmol/L) 相关的事件。
参与者百分比的计算方法是将发生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。
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基线至 26 周，基线至 52 周
|
|
HbA1c 等于或小于 6.5% 且小于 7.0% 的参与者百分比
大体时间：最多 26 周，最多 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。
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最多 26 周，最多 52 周
|
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HbA1c 低于 7.0% 且无夜间低血糖的参与者百分比
大体时间：最多 26 周，最多 52 周
|
低血糖发作定义为与报告的低血糖症状和体征和/或记录的血糖浓度≤70 mg/dL (3.9 mmol/L) 相关的事件。
夜间低血糖事件发生在睡前和醒来之间以及晚上 10:00 和上午 10:00 之间。
参与者百分比的计算方法是将 HbA1c <7.0% 且无夜间低血糖的参与者人数除以所分析的参与者总数，再乘以 100。
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最多 26 周，最多 52 周
|
|
夜间低血糖率
大体时间：基线至 26 周，基线至 52 周
|
低血糖发作定义为与报告的低血糖体征和症状和/或记录的 BG 浓度≤70 mg/dL (3.9 mmol/L) 相关的事件。
夜间低血糖事件发生在睡前和醒来之间以及晚上 10:00 和上午 10:00 之间。
给出了夜间低血糖的组平均发生率（每 30 天），并根据负二项式回归模型计算（发作次数 = 治疗 + 基线夜间低血糖发生率，log [暴露天数/30] 作为偏移变量）。
组均值是通过首先对单个参与者协变量取反向链接函数然后对所有参与者取平均值来估计的。
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基线至 26 周，基线至 52 周
|
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夜间低血糖事件参与者的百分比
大体时间：基线至 26 周，基线至 52 周
|
低血糖发作定义为与报告的低血糖体征和症状和/或 BG 浓度≤70 mg/dL (3.9 mmol/L) 相关的事件。
夜间低血糖事件发生在睡前和醒来之间以及晚上 10:00 和上午 10:00 之间。
参与者百分比的计算方法是将夜间低血糖发作的参与者人数除以所分析的参与者总数，再乘以 100。
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基线至 26 周，基线至 52 周
|
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体重变化
大体时间：基线、26 周、52 周
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使用 MMRM 计算 LS 平均值，调整治疗、分层因素（基线 HbA1c [≤8.5% 和 >8.5%]、国家、基线 LDL-C [<100 mg/dL (2.6 mmol/L) 和 ≥100 mg/dL ( 2.6 mmol/L)]、基线之前的基础胰岛素治疗[甘精胰岛素/地特胰岛素/其他])、访视、治疗-访视相互作用和基线体重作为固定效应，参与者作为随机效应。
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基线、26 周、52 周
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9 点自我监测血糖 (SMBG)
大体时间：26周和52周
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在第 0、4、12、26、39 和 52 周之前的一周内的 2 天内获得了 9 点 SMBG 配置文件。
SMBG 测量在 9 个时间点进行：早餐前、早餐后 2 小时、午餐前、午餐后 2 小时、晚餐前、晚餐后 2 小时、就寝时间，大约在 0300小时，以及随后的早晨，早餐前。
使用 MMRM 计算 LS 平均值，调整治疗、分层因素（基线 HbA1c [≤8.5% 和 >8.5%]、国家、基线 LDL-C [<100 mg/dL (2.6 mmol/L) 和 ≥100 mg/dL ( 2.6 mmol/L)]、基线之前的基础胰岛素治疗[甘精胰岛素/地特胰岛素/其他])、访视、治疗-访视相互作用和基线 BG 值作为固定效应，参与者作为随机效应。
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26周和52周
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空腹血糖（通过实验室测量）
大体时间：26周和52周
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早餐前测量血液中的空腹血糖 (FSG)。
使用 MMRM 计算 LS 平均值，调整治疗、分层因素（基线 HbA1c [≤8.5% 和 >8.5%]、国家、基线 LDL-C [<100 mg/dL (2.6 mmol/L) 和 ≥100 mg/dL ( 2.6 mmol/L)]、基线之前的基础胰岛素治疗[甘精胰岛素/地特胰岛素/其他])、访视、治疗-访视相互作用和基线 HbA1c 作为固定效应，参与者作为随机效应。
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26周和52周
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空腹血糖（通过参与者自我监测的血糖读数）
大体时间：26周和52周
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空腹血糖 (FBG) 是通过 SMBG 早餐前测量的。
使用 MMRM 计算 LS 平均值，调整治疗、分层因素（基线 HbA1c [≤8.5% 和 >8.5%]、国家、基线 LDL-C [<100 mg/dL (2.6 mmol/L) 和 ≥100 mg/dL ( 2.6 mmol/L)]、基线之前的基础胰岛素治疗[甘精胰岛素/地特胰岛素/其他])、访视、治疗-访视相互作用和基线 FBG 作为固定效应，参与者作为随机效应。
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26周和52周
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空腹血糖 (FBG) 的参与者内部变异性
大体时间：26周和52周
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FBG 由 SMBG 测量。
日间葡萄糖变异性通过 FBG 的标准差 (SD) 来衡量。
使用 MMRM 计算 LS 平均值，调整治疗、分层因素（基线 HbA1c [≤8.5% 和 >8.5%]、国家、基线 LDL-C [<100 mg/dL (2.6 mmol/L) 和 ≥100 mg/dL ( 2.6 mmol/L)]、基线之前的基础胰岛素治疗[甘精胰岛素/地特胰岛素/其他])、访视、治疗-访视相互作用和 FBG 的基线 SD 作为固定效应，参与者作为随机效应。
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26周和52周
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0300 小时血糖 (BG) 到空腹 BG 偏移
大体时间：26周和52周
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提供了 0300 小时到早饭前 (FBG) 偏移的结果（仅包括单个 SMBG 配置文件中的偏移）。
使用 MMRM 计算 LS 平均值，调整治疗、分层因素（基线 HbA1c [≤8.5% 和 >8.5%]、国家、基线 LDL-C [<100 mg/dL (2.6 mmol/L) 和 ≥100 mg/dL ( 2.6 mmol/L)]、基线之前的基础胰岛素治疗[甘精胰岛素/地特胰岛素/其他])、访视、治疗-访视相互作用和基线偏移作为固定效应，参与者作为随机效应。
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26周和52周
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甘油三酯、低密度脂蛋白胆固醇 (LDL-C)、高密度脂蛋白胆固醇 (HDL-C) 和总胆固醇
大体时间：26周和52周
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提供了胆固醇、HDL-C 和 LDL-C 以及甘油三酯的浓度。
使用 MMRM 调整分层因素（基线 HbA1c [≤8.5% 和 >8.5%]、国家、LDL-C [<100 mg/dL (2.6 mmol/L) 和≥100 mg/dL (2.6 mmol/ L), 除了 LDL-C 结果变量], 既往基础胰岛素治疗 [甘精胰岛素/地特胰岛素/其他]), 就诊, 治疗, 治疗与就诊相互作用, 以及相应血脂结果变量的基线值作为固定效应和参与者作为随机效应。
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26周和52周
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抗 LY2605541 抗体发生变化的参与者百分比
大体时间：26周、52周
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总结了具有抗 LY2605541 治疗紧急抗体反应 (TEAR) 的参与者的百分比。
撕裂被定义为抗 LY2605541 抗体水平从基线到基线后的变化，从不可检测到可检测，或从可检测到相对基线至少增加 130% 的值。
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26周、52周
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基础、进餐时间和单位体重的总胰岛素剂量
大体时间：26周和52周
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基础胰岛素剂量、餐时胰岛素剂量（短效推注剂量）和总胰岛素剂量是根据治疗后就诊前最后 7 天或随机化就诊前最后 3 天的剂量计算的。
使用约束纵向数据分析 (cLDA) 模型计算 LS 平均值，该模型在每次基线后访视时调整每个治疗组的指标变量和分层变量（基线 HbA1c [≤8.5% 和 > 8.5%]、国家、基线 LDL-C [< 100 mg/dL (2.6 mmol/L) 和 ≥100 mg/dL (2.6 mmol/L)]，以及基线之前的基础胰岛素治疗 [甘精胰岛素/地特胰岛素/其他]) 作为固定效应。
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26周和52周
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胰岛素治疗满意度问卷
大体时间：长达 52 周
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胰岛素治疗满意度问卷 (ITSQ) 是一项经过验证的衡量标准，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：养生法的便利性、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。
数据被转换为 0-100 的等级，其中较高的分数表示较好的治疗满意度。
使用 ANCOVA 模型计算 LS 均值，调整治疗、基线 HbA1c（≤8.5% 和 >8.5%）、国家和基线之前的基础胰岛素治疗（甘精胰岛素/地特胰岛素/其他）作为固定效应，基线 ITSQ 评分作为协变量.
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长达 52 周
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欧洲生活质量-5维（EQ-5D-3L）
大体时间：长达 52 周
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EQ-5D-3L 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 1-3 的三级量表（没有问题、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。
使用针对治疗、基线 HbA1c（≤8.5% 和 >8.5%）、国家、基线之前基础胰岛素治疗（甘精胰岛素/地特胰岛素/其他）和基线 EQ-5D-3L 评分作为协变量进行调整的 ANCOVA 计算 LS 平均值。
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长达 52 周
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成人低血糖调查
大体时间：26周和52周
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低血糖调查 (LBSS)（也称为低血糖恐惧调查 - II [HFS-II]）是一项调查问卷，用于测量 1) 避免低血糖及其负面后果的行为（15 项）和 2) 对低血糖及其负面影响的担忧后果（18 项）。
响应采用 5 点李克特式量表，其中 0 = 从不，4 = 总是。
总分是所有项目的总和（范围 0-132）。
较高的总分反映了对低血糖的更大恐惧。
使用 MMRM 计算 LS 均值，调整治疗、基线 HbA1c（≤8.5% 和 >8.5%）、国家、基线之前的基础胰岛素治疗（甘精胰岛素/地特胰岛素/其他）、就诊、治疗-就诊相互作用和基线 LBSS分数作为固定效应，参与者作为随机效应。
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26周和52周
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身体活动快速评估 (RAPA)
大体时间：52周
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RAPA 问卷评估成人参与者的身体活动水平和强度。
它包含 2 个分量表：RAPA 1（有氧）和 RAPA 2（力量和柔韧性）。
RAPA 1 包含 7 个关于参与者身体活动量和强度的问题，允许将每个参与者的有氧活动水平分类为久坐、活动不足、轻度活动、经常活动不足或活跃。
RAPA 2 包含 2 个关于参与者增强力量和提高灵活性的身体活动的问题。
每个参与者的力量和柔韧性活动水平然后被归类为既不是力量也不是柔韧性活动、力量或柔韧性活动（不是两者）、力量和柔韧性活动。
每个 RAPA 1/2 类别中参与者的百分比被呈现，并通过将每个 RAPA 1/2 类别中的参与者人数除以分析的参与者总数，再乘以 100 来计算。
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52周
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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。
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
- Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.
- Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.
- Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.
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
2012年1月1日
初级完成 (实际的)
2014年2月1日
研究完成 (实际的)
2014年2月1日
研究注册日期
首次提交
2011年10月14日
首先提交符合 QC 标准的
2011年10月14日
首次发布 (估计)
2011年10月18日
研究记录更新
最后更新发布 (实际的)
2018年4月17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
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.