A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (PRONTO-T2D)
2020년 3월 12일 업데이트: 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).
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
933
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Taichung, 대만, 40201
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Taipei, 대만, 11031
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Taipei, 대만, 10507
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Taipei, 대만, 23148
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Yongkang, 대만, 71004
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Ansan-si, 대한민국, 15355
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Daegu, 대한민국, 41931
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Daejeon, 대한민국, 35233
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Gangwon-do, 대한민국, 24289
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Gangwon-do, 대한민국, 26426
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Seoul, 대한민국, 06351
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Seoul, 대한민국, 03181
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Seoul, 대한민국, 02841
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Seoul, 대한민국, 05278
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Seoul, 대한민국, 06591
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Seoul, 대한민국, 07061
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Seoul, 대한민국, 01830
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Seoul, 대한민국, 08308
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Gyeonggi-do
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Bucheon, Gyeonggi-do, 대한민국, 14647
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Hamburg, 독일, 22607
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Baden-Württemberg
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Bad Mergentheim, Baden-Württemberg, 독일, 97980
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Brandenburg
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Falkensee, Brandenburg, 독일, 14612
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Hessen
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Pohlheim, Hessen, 독일, 35415
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Nordrhein-Westfalen
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Münster, Nordrhein-Westfalen, 독일, 48145
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Rheinland-Pfalz
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Mayen, Rheinland-Pfalz, 독일, 56727
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Saarland
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Saint Ingbert-Oberwürzbach, Saarland, 독일, 66386
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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, 독일, 39120
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Schleswig-Holstein
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Oldenburg, Schleswig-Holstein, 독일, 23758
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Arkhangel'sk, 러시아 연방, 163045
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Kursk, 러시아 연방, 305014
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Moscow, 러시아 연방, 119435
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Moscow, 러시아 연방, 123182
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Saint Petersburg, 러시아 연방, 195257
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Saratov, 러시아 연방, 410053
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Jalisco, 멕시코, 44650
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Monterrey, 멕시코, 64460
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Zapopan, 멕시코, 45116
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Zapopan, 멕시코, 45030
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California
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Fresno, California, 미국, 93720
- Valley Research
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La Mesa, California, 미국, 91942
- Diabetes and Endocrine Associates
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Lancaster, California, 미국, 93534
- First Valley Medical Group
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Los Angeles, California, 미국, 90057
- National Research Institute
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Santa Clarita, California, 미국, 91321
- Care Access Research
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Spring Valley, California, 미국, 91978
- Encompass Clinical Research
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Tustin, California, 미국, 92780
- University Clinical Investigators, Inc.
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Florida
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Cooper City, Florida, 미국, 33024
- ALL Medical Research, LLC
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Fort Lauderdale, Florida, 미국, 33312
- The Center For Diabetes & Endocrine Care
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Jacksonville, Florida, 미국, 32216
- East Coast Institute for Research
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New Port Richey, Florida, 미국, 34652
- Sun Coast Clinical Research, Inc
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Hawaii
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Honolulu, Hawaii, 미국, 96814
- East West Medical Institute
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Idaho
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Blackfoot, Idaho, 미국, 83221
- Elite Clinical Trials LLLP
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Boise, Idaho, 미국, 83704
- Northwest Clinical Trials
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Idaho Falls, Idaho, 미국, 83404
- Rocky Mountain Diabetes and Osteoporosis Center
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Illinois
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Springfield, Illinois, 미국, 62711
- Prairie Education And Research Cooperative
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Iowa
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West Des Moines, Iowa, 미국, 50265
- Iderc, P.L.C.
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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Kansas City, Kansas, 미국, 66606
- Cotton O'Neil Diabetes and Endocrinology Center
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Nevada
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Las Vegas, Nevada, 미국, 89148
- Palm Research Center
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Las Vegas, Nevada, 미국, 89128
- Palm Research Center
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New York
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New York, New York, 미국, 10016
- Manhattan Medical Research
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Ohio
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Columbus, Ohio, 미국, 43213
- Aventiv Research
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Pennsylvania
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Beaver, Pennsylvania, 미국, 15009
- Heritage Valley Medical Group, Inc.
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Pittsburgh, Pennsylvania, 미국, 15224
- Partners in Nephrology & Endocrinology
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Texas
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Austin, Texas, 미국, 78731-4309
- Texas Diabetes and Endocrinology
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Austin, Texas, 미국, 78749
- Texas Diabetes and Endocrinology-Austin South
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Dallas, Texas, 미국, 75230
- Dallas Diabetes Endocrine Center
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Shavano Park, Texas, 미국, 78231
- Consano Clinical Research
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Utah
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Bountiful, Utah, 미국, 84010
- Progressive Clinical Research
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Washington
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Federal Way, Washington, 미국, 98003
- Private: Dr. Larry Stonesifer
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Renton, Washington, 미국, 98057
- Rainier Clinical Research Center
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Lleida, 스페인, 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.
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Málaga, 스페인, 29006
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Sevilla, 스페인, 41010
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Sevilla, 스페인, 41003
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Malacky, 슬로바키아, 90101
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Nove Mesto nad Vahom, 슬로바키아, 91501
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Púchov, 슬로바키아, 02001
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Rožňava, 슬로바키아, 048 01
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Slovak Republic
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Košice, Slovak Republic, 슬로바키아, 04012
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Buenos Aires
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Caba, Buenos Aires, 아르헨티나, 1425
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Caba, Buenos Aires, 아르헨티나, C1013AAB
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Caba, Buenos Aires, 아르헨티나, C1179AAB
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Ciudad Autonoma de Buenos Aire, Buenos Aires, 아르헨티나, 1408
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Ciudad Autonoma de Buenos Aire, Buenos Aires, 아르헨티나, C1056ABJ
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Ciudad Autonoma de Buenos Aire, Buenos Aires, 아르헨티나, C1204AAD
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Mar del Plata, Buenos Aires, 아르헨티나, B7600FZN
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Palmero, 이탈리아, 90127
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Sesto San Giovanni, 이탈리아, 20099
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Gujarat
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Ahmedabad, Gujarat, 인도, 380015
- 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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Ahmedabad, Gujarat, 인도, 380015
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Ahmedabad, Gujarat, 인도, 380016
- 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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Karnataka
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Bangalore, Karnataka, 인도, 560017
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Bangalore, Karnataka, 인도, 560054
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Maharashtra
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Pune, Maharashtra, 인도, 411004
- 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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Pune, Maharashtra, 인도, 411011
- 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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Maharshtra
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Mumbai, Maharshtra, 인도, 400012
- 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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Rajasthan
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Jaipur, Rajasthan, 인도, 302017
- 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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Tamil Nadu
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Chennai, Tamil Nadu, 인도, 600086
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Telangana
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Hyderabad, Telangana, 인도, 500012
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Hyderabad, Telangana, 인도, 500072
- 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, 일본, 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.
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Fukuoka, 일본, 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.
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Fukuoka, 일본, 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.
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Hyōgo, 일본, 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
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Kanagawa, 일본, 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.
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Kanagawa, 일본, 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.
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Kumamoto, 일본, 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."
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Miyazaki, 일본, 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.
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Naka, 일본, 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.
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Sapporo, 일본, 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.
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Sapporo, 일본, 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.
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Sasebo, 일본, 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, 일본, 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.
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Tama, 일본, 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.
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Tokyo, 일본, 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, 일본, 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.
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Tokyo, 일본, 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.
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Tokyo, 일본, 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.
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Yamato, 일본, 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.
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Ōita, 일본, 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.
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Ōsaka, 일본, 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.
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Ōsaka, 일본, 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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Krnov, 체코, 79401
- 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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Pardubice, 체코, 53002
- 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.
-
Praha, 체코, 104 00
- 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.
-
Praha, 체코, 149 00
- 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.
-
Praha, 체코, 181 00
- 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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Caguas, 푸에르토 리코, 00726
- Centro de Endocrinologia y Nutricion del Turabo
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Manati, 푸에르토 리코, 00674
- Manati Center for Clinical Research Inc
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Ponce, 푸에르토 리코, 00716
- Ponce School of Medicine CAIMED Center
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Ponce, 푸에르토 리코, 00717-1332
- Research and Cardiovascular Corp.
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San Juan, 푸에르토 리코, 00917
- GCM Medical Group PSC
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Budapest, 헝가리, 1089
- 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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Budapest, 헝가리, 1139
- 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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Budapest, 헝가리, 1213
- 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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Nagykanizsa, 헝가리, 8800
- 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 Australia
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Keswick, South Australia, 호주, 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.
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Oaklands Park, South Australia, 호주, 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.
-
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Victoria
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Box Hill, Victoria, 호주, 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, 호주, 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
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Fremantle, Western Australia, 호주, 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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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
관리 SC
다른 이름들:
관리 SC
관리 SC
구두로 관리.
Administered orally.
|
|
활성 비교기: 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.
|
관리 SC
관리 SC
구두로 관리.
관리 SC
다른 이름들:
Administered orally.
|
|
실험적: 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.
|
관리 SC
다른 이름들:
관리 SC
관리 SC
구두로 관리.
Administered orally.
|
|
활성 비교기: 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.
|
관리 SC
관리 SC
구두로 관리.
관리 SC
다른 이름들:
Administered orally.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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%
기간: Week 26
|
Number of participants with HbA1c <7% at Week 26.
|
Week 26
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 7월 14일
기본 완료 (실제)
2018년 8월 14일
연구 완료 (실제)
2019년 3월 13일
연구 등록 날짜
최초 제출
2017년 7월 10일
QC 기준을 충족하는 최초 제출
2017년 7월 10일
처음 게시됨 (실제)
2017년 7월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 3월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 3월 12일
마지막으로 확인됨
2019년 8월 15일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 16314
- I8B-MC-ITRN (기타 식별자: Eli Lilly and Company)
- 2015-005357-12 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
제2형 당뇨병에 대한 임상 시험
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Postgraduate Institute of Medical Education and...완전한
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Hangzhou SynRx Therapeutics Biomedical Technology...모병유방암 | 난소 암 | 고급 고형 종양 | 전이성 고형 종양 | BRCA 1/2 및/또는 HRD중국
LY900014에 대한 임상 시험
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Eli Lilly and Company완전한
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Eli Lilly and Company완전한