A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (PRONTO-T2D)
2020. március 12. frissítette: 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).
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Tanulmány típusa
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Beiratkozás (Tényleges)
933
Fázis
- 3. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Buenos Aires
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Caba, Buenos Aires, Argentína, 1425
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Caba, Buenos Aires, Argentína, C1013AAB
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Caba, Buenos Aires, Argentína, C1179AAB
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentína, 1408
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentína, C1056ABJ
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentína, C1204AAD
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Mar del Plata, Buenos Aires, Argentína, B7600FZN
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South Australia
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Keswick, South Australia, Ausztrália, 5035
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Oaklands Park, South Australia, Ausztrália, 5046
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Victoria
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Box Hill, Victoria, Ausztrália, 3128
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Geelong, Victoria, Ausztrália, 3220
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Western Australia
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Fremantle, Western Australia, Ausztrália, 6959
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Krnov, Csehország, 79401
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Pardubice, Csehország, 53002
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Praha, Csehország, 104 00
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Praha, Csehország, 149 00
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Praha, Csehország, 181 00
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California
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Fresno, California, Egyesült Államok, 93720
- Valley Research
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La Mesa, California, Egyesült Államok, 91942
- Diabetes and Endocrine Associates
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Lancaster, California, Egyesült Államok, 93534
- First Valley Medical Group
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Los Angeles, California, Egyesült Államok, 90057
- National Research Institute
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Santa Clarita, California, Egyesült Államok, 91321
- Care Access Research
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Spring Valley, California, Egyesült Államok, 91978
- Encompass Clinical Research
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Tustin, California, Egyesült Államok, 92780
- University Clinical Investigators, Inc.
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Florida
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Cooper City, Florida, Egyesült Államok, 33024
- ALL Medical Research, LLC
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Fort Lauderdale, Florida, Egyesült Államok, 33312
- The Center For Diabetes & Endocrine Care
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Jacksonville, Florida, Egyesült Államok, 32216
- East Coast Institute for Research
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New Port Richey, Florida, Egyesült Államok, 34652
- Sun Coast Clinical Research, Inc
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Hawaii
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Honolulu, Hawaii, Egyesült Államok, 96814
- East West Medical Institute
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Idaho
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Blackfoot, Idaho, Egyesült Államok, 83221
- Elite Clinical Trials LLLP
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Boise, Idaho, Egyesült Államok, 83704
- Northwest Clinical Trials
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Idaho Falls, Idaho, Egyesült Államok, 83404
- Rocky Mountain Diabetes and Osteoporosis Center
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Illinois
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Springfield, Illinois, Egyesült Államok, 62711
- Prairie Education And Research Cooperative
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Iowa
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West Des Moines, Iowa, Egyesült Államok, 50265
- Iderc, P.L.C.
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Kansas
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Kansas City, Kansas, Egyesült Államok, 66160
- University of Kansas Medical Center
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Kansas City, Kansas, Egyesült Államok, 66606
- Cotton O'Neil Diabetes and Endocrinology Center
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Nevada
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Las Vegas, Nevada, Egyesült Államok, 89148
- Palm Research Center
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Las Vegas, Nevada, Egyesült Államok, 89128
- Palm Research Center
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New York
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New York, New York, Egyesült Államok, 10016
- Manhattan Medical Research
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Ohio
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Columbus, Ohio, Egyesült Államok, 43213
- Aventiv Research
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Pennsylvania
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Beaver, Pennsylvania, Egyesült Államok, 15009
- Heritage Valley Medical Group, Inc.
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Pittsburgh, Pennsylvania, Egyesült Államok, 15224
- Partners in Nephrology & Endocrinology
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Texas
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Austin, Texas, Egyesült Államok, 78731-4309
- Texas Diabetes and Endocrinology
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Austin, Texas, Egyesült Államok, 78749
- Texas Diabetes and Endocrinology-Austin South
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Dallas, Texas, Egyesült Államok, 75230
- Dallas Diabetes Endocrine Center
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Shavano Park, Texas, Egyesült Államok, 78231
- Consano Clinical Research
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Utah
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Bountiful, Utah, Egyesült Államok, 84010
- Progressive Clinical Research
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Washington
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Federal Way, Washington, Egyesült Államok, 98003
- Private: Dr. Larry Stonesifer
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Renton, Washington, Egyesült Államok, 98057
- Rainier Clinical Research Center
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Gujarat
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Ahmedabad, Gujarat, India, 380015
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Ahmedabad, Gujarat, India, 380015
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Ahmedabad, Gujarat, India, 380016
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Karnataka
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Bangalore, Karnataka, India, 560017
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Bangalore, Karnataka, India, 560054
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Maharashtra
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Pune, Maharashtra, India, 411004
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Pune, Maharashtra, India, 411011
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Maharshtra
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Mumbai, Maharshtra, India, 400012
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Rajasthan
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Jaipur, Rajasthan, India, 302017
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600086
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Telangana
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Hyderabad, Telangana, India, 500012
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Hyderabad, Telangana, India, 500072
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Chiba, Japán, 277-0825
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Fukuoka, Japán, 815-8555
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Fukuoka, Japán, 830-8543
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Hyōgo, Japán, 661-0002
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Kanagawa, Japán, 247-0056
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Kanagawa, Japán, 235-0045
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Kumamoto, Japán, 862-0976
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Miyazaki, Japán, 880-0034
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Naka, Japán, 311-0113
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Sapporo, Japán, 060-0001
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Sapporo, Japán, 060-0062
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Sasebo, Japán, 857-1195
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Sendai, Japán, 980-0021
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Tama, Japán, 206-0033
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Tokyo, Japán, 103-0027
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Tokyo, Japán, 1030002
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Tokyo, Japán, 160 0022
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Tokyo, Japán, 143-0015
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Yamato, Japán, 242-0004
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Ōita, Japán, 870-0039
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Ōsaka, Japán, 530-0001
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Ōsaka, Japán, 534-0021
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Ansan-si, Koreai Köztársaság, 15355
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Daegu, Koreai Köztársaság, 41931
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Daejeon, Koreai Köztársaság, 35233
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Gangwon-do, Koreai Köztársaság, 24289
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Gangwon-do, Koreai Köztársaság, 26426
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Seoul, Koreai Köztársaság, 06351
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Seoul, Koreai Köztársaság, 03181
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Seoul, Koreai Köztársaság, 02841
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Seoul, Koreai Köztársaság, 05278
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Seoul, Koreai Köztársaság, 06591
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Seoul, Koreai Köztársaság, 07061
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Seoul, Koreai Köztársaság, 01830
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Seoul, Koreai Köztársaság, 08308
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Gyeonggi-do
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Bucheon, Gyeonggi-do, Koreai Köztársaság, 14647
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Budapest, Magyarország, 1089
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Budapest, Magyarország, 1139
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Budapest, Magyarország, 1213
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Nagykanizsa, Magyarország, 8800
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Jalisco, Mexikó, 44650
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Monterrey, Mexikó, 64460
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Zapopan, Mexikó, 45116
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Zapopan, Mexikó, 45030
- 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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Hamburg, Németország, 22607
- 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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Baden-Württemberg
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Bad Mergentheim, Baden-Württemberg, Németország, 97980
- 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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Brandenburg
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Falkensee, Brandenburg, Németország, 14612
- 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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Hessen
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Pohlheim, Hessen, Németország, 35415
- 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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Nordrhein-Westfalen
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Münster, Nordrhein-Westfalen, Németország, 48145
- 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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Rheinland-Pfalz
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Mayen, Rheinland-Pfalz, Németország, 56727
- 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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Saarland
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Saint Ingbert-Oberwürzbach, Saarland, Németország, 66386
- 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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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Németország, 39120
- 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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Schleswig-Holstein
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Oldenburg, Schleswig-Holstein, Németország, 23758
- 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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Palmero, Olaszország, 90127
- 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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Sesto San Giovanni, Olaszország, 20099
- 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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Arkhangel'sk, Orosz Föderáció, 163045
- 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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Kursk, Orosz Föderáció, 305014
- 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, Orosz Föderáció, 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, Orosz Föderáció, 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, Orosz Föderáció, 195257
- 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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Saratov, Orosz Föderáció, 410053
- 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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Caguas, Puerto Rico, 00726
- Centro de Endocrinologia y Nutricion del Turabo
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Manati, Puerto Rico, 00674
- Manati Center for Clinical Research Inc
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Ponce, Puerto Rico, 00716
- Ponce School of Medicine CAIMED Center
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Ponce, Puerto Rico, 00717-1332
- Research and Cardiovascular Corp.
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San Juan, Puerto Rico, 00917
- GCM Medical Group PSC
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Lleida, Spanyolország, 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, Spanyolország, 29006
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sevilla, Spanyolország, 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.
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Sevilla, Spanyolország, 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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Malacky, Szlovákia, 90101
- 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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Nove Mesto nad Vahom, Szlovákia, 91501
- 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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Púchov, Szlovákia, 02001
- 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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Rožňava, Szlovákia, 048 01
- 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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Slovak Republic
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Košice, Slovak Republic, Szlovákia, 04012
- 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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Taichung, Tajvan, 40201
- 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, Tajvan, 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, Tajvan, 10507
- 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, Tajvan, 23148
- 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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Yongkang, Tajvan, 71004
- 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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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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.
|
SC beadva
Más nevek:
SC beadva
SC beadva
Orálisan beadva.
Administered orally.
|
|
Aktív összehasonlító: 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.
|
SC beadva
SC beadva
Orálisan beadva.
SC beadva
Más nevek:
Administered orally.
|
|
Kísérleti: 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.
|
SC beadva
Más nevek:
SC beadva
SC beadva
Orálisan beadva.
Administered orally.
|
|
Aktív összehasonlító: 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.
|
SC beadva
SC beadva
Orálisan beadva.
SC beadva
Más nevek:
Administered orally.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
Időkeret: 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
Időkeret: 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
Időkeret: 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
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Rate of Documented Symptomatic Hypoglycemia
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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%
Időkeret: Week 26
|
Number of participants with HbA1c <7% at Week 26.
|
Week 26
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2017. július 14.
Elsődleges befejezés (Tényleges)
2018. augusztus 14.
A tanulmány befejezése (Tényleges)
2019. március 13.
Tanulmányi regisztráció dátumai
Először benyújtva
2017. július 10.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2017. július 10.
Első közzététel (Tényleges)
2017. július 11.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2020. március 27.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2020. március 12.
Utolsó ellenőrzés
2019. augusztus 15.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Glükóz anyagcserezavarok
- Anyagcsere-betegségek
- Endokrin rendszer betegségei
- Diabetes mellitus
- Cukorbetegség, 2-es típusú
- Hipoglikémiás szerek
- A gyógyszerek élettani hatásai
- A farmakológiai hatás molekuláris mechanizmusai
- Inzulin
- Inzulin, Globin Cink
- Metformin
- Glargine inzulin
- Lispro inzulin
- Nátrium-glükóz transzporter 2 inhibitorok
Egyéb vizsgálati azonosító számok
- 16314
- I8B-MC-ITRN (Egyéb azonosító: Eli Lilly and Company)
- 2015-005357-12 (EudraCT szám)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
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 megosztási időkeret
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-megosztási hozzáférési feltételek
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- CSR
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Igen
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
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