A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (PRONTO-T2D)
2020年3月12日 更新者：Eli Lilly and Company
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
The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).
調査の概要
研究の種類
介入
入学 (実際)
933
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Fresno、California、アメリカ、93720
- Valley Research
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La Mesa、California、アメリカ、91942
- Diabetes and Endocrine Associates
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Lancaster、California、アメリカ、93534
- First Valley Medical Group
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Los Angeles、California、アメリカ、90057
- National Research Institute
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Santa Clarita、California、アメリカ、91321
- Care Access Research
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Spring Valley、California、アメリカ、91978
- Encompass Clinical Research
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Tustin、California、アメリカ、92780
- University Clinical Investigators, Inc.
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Florida
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Cooper City、Florida、アメリカ、33024
- ALL Medical Research, LLC
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Fort Lauderdale、Florida、アメリカ、33312
- The Center For Diabetes & Endocrine Care
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Jacksonville、Florida、アメリカ、32216
- East Coast Institute for Research
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New Port Richey、Florida、アメリカ、34652
- Sun Coast Clinical Research, Inc
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Hawaii
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Honolulu、Hawaii、アメリカ、96814
- East West Medical Institute
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Idaho
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Blackfoot、Idaho、アメリカ、83221
- Elite Clinical Trials LLLP
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Boise、Idaho、アメリカ、83704
- Northwest Clinical Trials
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Idaho Falls、Idaho、アメリカ、83404
- Rocky Mountain Diabetes and Osteoporosis Center
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Illinois
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Springfield、Illinois、アメリカ、62711
- Prairie Education And Research Cooperative
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Iowa
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West Des Moines、Iowa、アメリカ、50265
- Iderc, P.L.C.
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Kansas
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Kansas City、Kansas、アメリカ、66160
- University Of Kansas Medical Center
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Kansas City、Kansas、アメリカ、66606
- Cotton O'Neil Diabetes and Endocrinology Center
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Nevada
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Las Vegas、Nevada、アメリカ、89148
- Palm Research Center
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Las Vegas、Nevada、アメリカ、89128
- Palm Research Center
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New York
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New York、New York、アメリカ、10016
- Manhattan Medical Research
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Ohio
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Columbus、Ohio、アメリカ、43213
- Aventiv Research
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Pennsylvania
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Beaver、Pennsylvania、アメリカ、15009
- Heritage Valley Medical Group, Inc.
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Pittsburgh、Pennsylvania、アメリカ、15224
- Partners in Nephrology & Endocrinology
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Texas
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Austin、Texas、アメリカ、78731-4309
- Texas Diabetes and Endocrinology
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Austin、Texas、アメリカ、78749
- Texas Diabetes and Endocrinology-Austin South
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Dallas、Texas、アメリカ、75230
- Dallas Diabetes Endocrine Center
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Shavano Park、Texas、アメリカ、78231
- Consano Clinical Research
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Utah
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Bountiful、Utah、アメリカ、84010
- Progressive Clinical Research
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Washington
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Federal Way、Washington、アメリカ、98003
- Private: Dr. Larry Stonesifer
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Renton、Washington、アメリカ、98057
- Rainier Clinical Research Center
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Buenos Aires
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Caba、Buenos Aires、アルゼンチン、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.
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Caba、Buenos Aires、アルゼンチン、C1013AAB
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Caba、Buenos Aires、アルゼンチン、C1179AAB
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Ciudad Autonoma de Buenos Aire、Buenos Aires、アルゼンチン、1408
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Ciudad Autonoma de Buenos Aire、Buenos Aires、アルゼンチン、C1056ABJ
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Ciudad Autonoma de Buenos Aire、Buenos Aires、アルゼンチン、C1204AAD
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Mar del Plata、Buenos Aires、アルゼンチン、B7600FZN
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Palmero、イタリア、90127
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Sesto San Giovanni、イタリア、20099
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Gujarat
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Ahmedabad、Gujarat、インド、380015
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Ahmedabad、Gujarat、インド、380015
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Ahmedabad、Gujarat、インド、380016
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Karnataka
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Bangalore、Karnataka、インド、560017
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Bangalore、Karnataka、インド、560054
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Maharashtra
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Pune、Maharashtra、インド、411004
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Pune、Maharashtra、インド、411011
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Maharshtra
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Mumbai、Maharshtra、インド、400012
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Rajasthan
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Jaipur、Rajasthan、インド、302017
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Tamil Nadu
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Chennai、Tamil Nadu、インド、600086
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Telangana
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Hyderabad、Telangana、インド、500012
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Hyderabad、Telangana、インド、500072
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South Australia
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Keswick、South Australia、オーストラリア、5035
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Oaklands Park、South Australia、オーストラリア、5046
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Victoria
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Box Hill、Victoria、オーストラリア、3128
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Geelong、Victoria、オーストラリア、3220
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Western Australia
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Fremantle、Western Australia、オーストラリア、6959
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Lleida、スペイン、25198
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Málaga、スペイン、29006
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Sevilla、スペイン、41010
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Sevilla、スペイン、41003
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Malacky、スロバキア、90101
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Nove Mesto nad Vahom、スロバキア、91501
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Púchov、スロバキア、02001
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Rožňava、スロバキア、048 01
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Slovak Republic
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Košice、Slovak Republic、スロバキア、04012
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Krnov、チェコ、79401
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Pardubice、チェコ、53002
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Praha、チェコ、104 00
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Praha、チェコ、149 00
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Praha、チェコ、181 00
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Hamburg、ドイツ、22607
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Baden-Württemberg
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Bad Mergentheim、Baden-Württemberg、ドイツ、97980
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Brandenburg
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Falkensee、Brandenburg、ドイツ、14612
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Hessen
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Pohlheim、Hessen、ドイツ、35415
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Nordrhein-Westfalen
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Münster、Nordrhein-Westfalen、ドイツ、48145
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Rheinland-Pfalz
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Mayen、Rheinland-Pfalz、ドイツ、56727
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Saarland
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Saint Ingbert-Oberwürzbach、Saarland、ドイツ、66386
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Sachsen-Anhalt
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Magdeburg、Sachsen-Anhalt、ドイツ、39120
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Schleswig-Holstein
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Oldenburg、Schleswig-Holstein、ドイツ、23758
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Budapest、ハンガリー、1089
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Budapest、ハンガリー、1139
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Budapest、ハンガリー、1213
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Nagykanizsa、ハンガリー、8800
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Caguas、プエルトリコ、00726
- Centro de Endocrinologia y Nutricion del Turabo
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Manati、プエルトリコ、00674
- Manati Center for Clinical Research Inc
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Ponce、プエルトリコ、00716
- Ponce School of Medicine CAIMED Center
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Ponce、プエルトリコ、00717-1332
- Research and Cardiovascular Corp.
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San Juan、プエルトリコ、00917
- GCM Medical Group PSC
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Jalisco、メキシコ、44650
- 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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Monterrey、メキシコ、64460
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Zapopan、メキシコ、45116
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Zapopan、メキシコ、45030
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Arkhangel'sk、ロシア連邦、163045
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Kursk、ロシア連邦、305014
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Moscow、ロシア連邦、119435
- 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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Moscow、ロシア連邦、123182
- 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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Saint Petersburg、ロシア連邦、195257
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Saratov、ロシア連邦、410053
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Taichung、台湾、40201
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Taipei、台湾、11031
- 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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Taipei、台湾、10507
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Taipei、台湾、23148
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Yongkang、台湾、71004
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Ansan-si、大韓民国、15355
- 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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Daegu、大韓民国、41931
- 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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Daejeon、大韓民国、35233
- 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.
-
Gangwon-do、大韓民国、24289
- 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.
-
Gangwon-do、大韓民国、26426
- 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.
-
Seoul、大韓民国、06351
- 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.
-
Seoul、大韓民国、03181
- 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.
-
Seoul、大韓民国、02841
- 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.
-
Seoul、大韓民国、05278
- 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.
-
Seoul、大韓民国、06591
- 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.
-
Seoul、大韓民国、07061
- 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.
-
Seoul、大韓民国、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.
-
Seoul、大韓民国、08308
- 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.
-
-
Gyeonggi-do
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Bucheon、Gyeonggi-do、大韓民国、14647
- 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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Chiba、日本、277-0825
- 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.
-
Fukuoka、日本、815-8555
- 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.
-
Fukuoka、日本、830-8543
- 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.
-
Hyōgo、日本、661-0002
- 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
-
Kanagawa、日本、247-0056
- 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.
-
Kanagawa、日本、235-0045
- 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.
-
Kumamoto、日本、862-0976
- "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."
-
Miyazaki、日本、880-0034
- 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.
-
Naka、日本、311-0113
- 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.
-
Sapporo、日本、060-0001
- 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.
-
Sapporo、日本、060-0062
- 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.
-
Sasebo、日本、857-1195
- 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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Sendai、日本、980-0021
- 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.
-
Tama、日本、206-0033
- 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.
-
Tokyo、日本、103-0027
- 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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Tokyo、日本、1030002
- 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.
-
Tokyo、日本、160 0022
- 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.
-
Tokyo、日本、143-0015
- 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.
-
Yamato、日本、242-0004
- 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.
-
Ōita、日本、870-0039
- 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.
-
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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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
管理SC
他の名前：
管理SC
管理SC
経口投与。
Administered orally.
|
|
アクティブコンパレータ：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.
|
管理SC
管理SC
経口投与。
管理SC
他の名前：
Administered orally.
|
|
実験的：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.
|
管理SC
他の名前：
管理SC
管理SC
経口投与。
Administered orally.
|
|
アクティブコンパレータ：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.
|
管理SC
管理SC
経口投与。
管理SC
他の名前：
Administered orally.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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%
時間枠：Week 26
|
Number of participants with HbA1c <7% at Week 26.
|
Week 26
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年7月14日
一次修了 (実際)
2018年8月14日
研究の完了 (実際)
2019年3月13日
試験登録日
最初に提出
2017年7月10日
QC基準を満たした最初の提出物
2017年7月10日
最初の投稿 (実際)
2017年7月11日
学習記録の更新
投稿された最後の更新 (実際)
2020年3月27日
QC基準を満たした最後の更新が送信されました
2020年3月12日
最終確認日
2019年8月15日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 16314
- I8B-MC-ITRN (その他の識別子：Eli Lilly and Company)
- 2015-005357-12 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 共有時間枠
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD 共有アクセス基準
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
2型糖尿病の臨床試験
LY900014の臨床試験
-
Eli Lilly and Company完了
-
Eli Lilly and Company完了