A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (PRONTO-T2D)
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes PRONTO-T2D
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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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、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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Budapest、匈牙利、1089
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Budapest、匈牙利、1139
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Budapest、匈牙利、1213
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Nagykanizsa、匈牙利、8800
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Gujarat
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Ahmedabad、Gujarat、印度、380015
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Ahmedabad、Gujarat、印度、380015
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Ahmedabad、Gujarat、印度、380016
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Karnataka
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Bangalore、Karnataka、印度、560017
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Bangalore、Karnataka、印度、560054
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Maharashtra
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Pune、Maharashtra、印度、411004
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Pune、Maharashtra、印度、411011
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Maharshtra
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Mumbai、Maharshtra、印度、400012
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Rajasthan
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Jaipur、Rajasthan、印度、302017
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Tamil Nadu
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Chennai、Tamil Nadu、印度、600086
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Telangana
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Hyderabad、Telangana、印度、500012
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Hyderabad、Telangana、印度、500072
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Taichung、台湾、40201
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Taipei、台湾、11031
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Taipei、台湾、10507
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Taipei、台湾、23148
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Yongkang、台湾、71004
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Jalisco、墨西哥、44650
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Monterrey、墨西哥、64460
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Zapopan、墨西哥、45116
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Zapopan、墨西哥、45030
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Ansan-si、大韩民国、15355
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Daegu、大韩民国、41931
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Daejeon、大韩民国、35233
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Gangwon-do、大韩民国、24289
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Gangwon-do、大韩民国、26426
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Seoul、大韩民国、06351
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Seoul、大韩民国、03181
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Seoul、大韩民国、02841
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Seoul、大韩民国、05278
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Seoul、大韩民国、06591
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Seoul、大韩民国、07061
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Seoul、大韩民国、01830
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Seoul、大韩民国、08308
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Gyeonggi-do
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Bucheon、Gyeonggi-do、大韩民国、14647
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Hamburg、德国、22607
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Baden-Württemberg
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Bad Mergentheim、Baden-Württemberg、德国、97980
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Brandenburg
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Falkensee、Brandenburg、德国、14612
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Hessen
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Pohlheim、Hessen、德国、35415
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Nordrhein-Westfalen
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Münster、Nordrhein-Westfalen、德国、48145
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Rheinland-Pfalz
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Mayen、Rheinland-Pfalz、德国、56727
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Saarland
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Saint Ingbert-Oberwürzbach、Saarland、德国、66386
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Sachsen-Anhalt
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Magdeburg、Sachsen-Anhalt、德国、39120
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Schleswig-Holstein
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Oldenburg、Schleswig-Holstein、德国、23758
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Palmero、意大利、90127
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Sesto San Giovanni、意大利、20099
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Krnov、捷克语、79401
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Pardubice、捷克语、53002
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Praha、捷克语、104 00
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Praha、捷克语、149 00
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Praha、捷克语、181 00
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Malacky、斯洛伐克、90101
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Nove Mesto nad Vahom、斯洛伐克、91501
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Púchov、斯洛伐克、02001
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Rožňava、斯洛伐克、048 01
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Slovak Republic
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Košice、Slovak Republic、斯洛伐克、04012
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Chiba、日本、277-0825
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Fukuoka、日本、815-8555
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Fukuoka、日本、830-8543
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Hyōgo、日本、661-0002
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Kanagawa、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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Sendai、日本、980-0021
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Tama、日本、206-0033
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Tokyo、日本、103-0027
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Tokyo、日本、1030002
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Tokyo、日本、160 0022
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Tokyo、日本、143-0015
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Yamato、日本、242-0004
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Ōita、日本、870-0039
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Ōsaka、日本、530-0001
- 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.
-
Ōsaka、日本、534-0021
- 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.
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-
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Caguas、波多黎各、00726
- Centro de Endocrinologia y Nutricion del Turabo
-
Manati、波多黎各、00674
- Manati Center for Clinical Research Inc
-
Ponce、波多黎各、00716
- Ponce School of Medicine CAIMED Center
-
Ponce、波多黎各、00717-1332
- Research and Cardiovascular Corp.
-
San Juan、波多黎各、00917
- GCM Medical Group PSC
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-
-
-
South Australia
-
Keswick、South Australia、澳大利亚、5035
- 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.
-
Oaklands Park、South Australia、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.
-
-
Victoria
-
Box Hill、Victoria、澳大利亚、3128
- 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.
-
Geelong、Victoria、澳大利亚、3220
- 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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Western Australia
-
Fremantle、Western Australia、澳大利亚、6959
- 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.
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California
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Fresno、California、美国、93720
- Valley Research
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La Mesa、California、美国、91942
- Diabetes and Endocrine Associates
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Lancaster、California、美国、93534
- First Valley Medical Group
-
Los Angeles、California、美国、90057
- National Research Institute
-
Santa Clarita、California、美国、91321
- Care Access Research
-
Spring Valley、California、美国、91978
- Encompass Clinical Research
-
Tustin、California、美国、92780
- University Clinical Investigators, Inc.
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-
Florida
-
Cooper City、Florida、美国、33024
- ALL Medical Research, LLC
-
Fort Lauderdale、Florida、美国、33312
- The Center For Diabetes & Endocrine Care
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Jacksonville、Florida、美国、32216
- East Coast Institute for Research
-
New Port Richey、Florida、美国、34652
- Sun Coast Clinical Research, Inc
-
-
Hawaii
-
Honolulu、Hawaii、美国、96814
- East West Medical Institute
-
-
Idaho
-
Blackfoot、Idaho、美国、83221
- Elite Clinical Trials LLLP
-
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
-
Kansas City、Kansas、美国、66606
- Cotton O'Neil Diabetes and Endocrinology Center
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Nevada
-
Las Vegas、Nevada、美国、89148
- Palm Research Center
-
Las Vegas、Nevada、美国、89128
- Palm Research Center
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-
New York
-
New York、New York、美国、10016
- Manhattan Medical Research
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Ohio
-
Columbus、Ohio、美国、43213
- Aventiv Research
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Pennsylvania
-
Beaver、Pennsylvania、美国、15009
- Heritage Valley Medical Group, Inc.
-
Pittsburgh、Pennsylvania、美国、15224
- Partners in Nephrology & Endocrinology
-
-
Texas
-
Austin、Texas、美国、78731-4309
- Texas Diabetes and Endocrinology
-
Austin、Texas、美国、78749
- Texas Diabetes and Endocrinology-Austin South
-
Dallas、Texas、美国、75230
- Dallas Diabetes Endocrine Center
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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
-
-
-
-
-
Lleida、西班牙、25198
- 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.
-
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、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.
-
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.
-
-
-
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Buenos Aires
-
Caba、Buenos Aires、阿根廷、1425
- 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、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.
-
Caba、Buenos Aires、阿根廷、C1179AAB
- 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、Buenos Aires、阿根廷、1408
- 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、Buenos Aires、阿根廷、C1056ABJ
- 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、Buenos Aires、阿根廷、C1204AAD
- 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.
-
Mar del Plata、Buenos Aires、阿根廷、B7600FZN
- 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.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Have been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening.
Have been treated for at least 90 days prior to screening with:
- Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn [NPH] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or
- Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily
Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:
- Metformin
- Dipeptidyl peptidase-4 (DPP-4) inhibitor
- Sodium glucose cotransporter 2 (SGLT2) inhibitor
- Sulfonylurea
- Meglitinide
- Alpha-glucoside inhibitor
- Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening.
- Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.
Exclusion Criteria:
- Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults.
- Have hypoglycemia unawareness as judged by the investigator.
- Have had any episode of severe hypoglycemia within the 6 months prior to screening.
- Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
- Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.
学习计划
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:LY900014
LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) insulin degludec given SC once daily.
Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
施行SC
其他名称:
施行SC
施行SC
口服给药。
Administered orally.
|
|
有源比较器:Insulin Lispro (Humalog)
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily.
Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
施行SC
施行SC
口服给药。
施行SC
其他名称:
Administered orally.
|
|
实验性的:LY900014 Maximum Extended Enrollment (MEE)
LY900014 given subcutaneously (SC) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily.
Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
施行SC
其他名称:
施行SC
施行SC
口服给药。
Administered orally.
|
|
有源比较器:Insulin Lispro (Humalog) MEE
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily.
Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
施行SC
施行SC
口服给药。
施行SC
其他名称:
Administered orally.
|
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 |
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
大体时间:Baseline, Week 26
|
Change from baseline in HbA1c was performed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value.
The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
|
Baseline, Week 26
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
大体时间:Week 26
|
1-hour PPG excursion during MMTT uses the analysis of covariance (ANCOVA) model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate.
The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
|
Week 26
|
|
2-hour PPG Excursion During MMTT Efficacy Estimand
大体时间:Week 26
|
2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate.
The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
|
Week 26
|
|
Rate of Severe Hypoglycemia
大体时间:Baseline through Week 26
|
Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525.
Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions.
During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience com with or without seizures, and may require parenteral therapy.
|
Baseline through Week 26
|
|
Rate of Documented Symptomatic Hypoglycemia
大体时间:Baseline through Week 26
|
Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)].
The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25)
as an offset variable.
|
Baseline through Week 26
|
|
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
大体时间:Baseline, Week 26
|
Change from baseline in 1,5-AG was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value.
The analysis included data collected prior to permanent discontinuation of study drug.
|
Baseline, Week 26
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
大体时间:Baseline, Week 26
|
Change from baseline in 10-point SMBG values was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value.
The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.
|
Baseline, Week 26
|
|
Change From Baseline in Insulin Dose at Week 26
大体时间:Baseline, Week 26
|
Change from baseline in insulin dose was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value.
The analysis included data prior to permanent discontinuation of study drug.
|
Baseline, Week 26
|
|
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26
大体时间:Baseline, Week 26
|
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. Change from baseline in ITSQ regimen inconvenience domain score was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. |
Baseline, Week 26
|
|
Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26
大体时间:Baseline, Week 26
|
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. Change from baseline in ITSQ lifestyle flexibility domain score was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. |
Baseline, Week 26
|
|
Number of Participants With HbA1c <7%
大体时间:Week 26
|
Number of participants with HbA1c <7% at Week 26.
|
Week 26
|
合作者和调查者
出版物和有用的链接
一般刊物
- Zhang Q, Chigutsa F, Chang AM. Efficacy and Safety of Ultra-Rapid Lispro in Younger and Older Patients with Type 2 Diabetes: Randomized Double-Blind PRONTO-T2D Study. Diabetes Ther. 2022 Aug;13(8):1547-1557. doi: 10.1007/s13300-022-01290-4. Epub 2022 Jul 4.
- Jinnouchi H, Imori M, Nishiyama H, Imaoka T. Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog(R) in Japanese Patients With Type 2 Diabetes: PRONTO-T2D Subpopulation Analysis. Diabetes Ther. 2020 Sep;11(9):2075-2088. doi: 10.1007/s13300-020-00890-2. Epub 2020 Jul 29.
- Blevins T, Zhang Q, Frias JP, Jinnouchi H, Chang AM; PRONTO-T2D Investigators. Randomized Double-Blind Clinical Trial Comparing Ultra Rapid Lispro With Lispro in a Basal-Bolus Regimen in Patients With Type 2 Diabetes: PRONTO-T2D. Diabetes Care. 2020 Dec;43(12):2991-2998. doi: 10.2337/dc19-2550. Epub 2020 Jul 2.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- 16314
- I8B-MC-ITRN (其他标识符:Eli Lilly and Company)
- 2015-005357-12 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.