- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03214380
A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (PRONTO-T2D)
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes PRONTO-T2D
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Hamburg, Allemagne, 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, Allemagne, 97980
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Brandenburg
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Falkensee, Brandenburg, Allemagne, 14612
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Hessen
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Pohlheim, Hessen, Allemagne, 35415
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Nordrhein-Westfalen
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Münster, Nordrhein-Westfalen, Allemagne, 48145
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Rheinland-Pfalz
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Mayen, Rheinland-Pfalz, Allemagne, 56727
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Saarland
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Saint Ingbert-Oberwürzbach, Saarland, Allemagne, 66386
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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Allemagne, 39120
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Schleswig-Holstein
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Oldenburg, Schleswig-Holstein, Allemagne, 23758
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Buenos Aires
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Caba, Buenos Aires, Argentine, 1425
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Caba, Buenos Aires, Argentine, C1013AAB
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Caba, Buenos Aires, Argentine, C1179AAB
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentine, 1408
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentine, C1056ABJ
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentine, C1204AAD
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Mar del Plata, Buenos Aires, Argentine, B7600FZN
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South Australia
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Keswick, South Australia, Australie, 5035
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Oaklands Park, South Australia, Australie, 5046
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Victoria
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Box Hill, Victoria, Australie, 3128
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Geelong, Victoria, Australie, 3220
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Western Australia
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Fremantle, Western Australia, Australie, 6959
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Ansan-si, Corée, République de, 15355
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Daegu, Corée, République de, 41931
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Daejeon, Corée, République de, 35233
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Gangwon-do, Corée, République de, 24289
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Gangwon-do, Corée, République de, 26426
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Seoul, Corée, République de, 06351
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Seoul, Corée, République de, 03181
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Seoul, Corée, République de, 02841
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Seoul, Corée, République de, 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.
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Seoul, Corée, République de, 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.
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Seoul, Corée, République de, 07061
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Seoul, Corée, République de, 01830
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Seoul, Corée, République de, 08308
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Gyeonggi-do
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Bucheon, Gyeonggi-do, Corée, République de, 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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Lleida, Espagne, 25198
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Málaga, Espagne, 29006
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Sevilla, Espagne, 41010
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Sevilla, Espagne, 41003
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Arkhangel'sk, Fédération Russe, 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, Fédération Russe, 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, Fédération Russe, 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, Fédération Russe, 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, Fédération Russe, 195257
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Saratov, Fédération Russe, 410053
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Budapest, Hongrie, 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, Hongrie, 1139
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Budapest, Hongrie, 1213
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Nagykanizsa, Hongrie, 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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Gujarat
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Ahmedabad, Gujarat, Inde, 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, Inde, 380015
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Ahmedabad, Gujarat, Inde, 380016
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Karnataka
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Bangalore, Karnataka, Inde, 560017
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Bangalore, Karnataka, Inde, 560054
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Maharashtra
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Pune, Maharashtra, Inde, 411004
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Pune, Maharashtra, Inde, 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, Inde, 400012
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Rajasthan
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Jaipur, Rajasthan, Inde, 302017
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Tamil Nadu
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Chennai, Tamil Nadu, Inde, 600086
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Telangana
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Hyderabad, Telangana, Inde, 500012
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Hyderabad, Telangana, Inde, 500072
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Palmero, Italie, 90127
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Sesto San Giovanni, Italie, 20099
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Chiba, Japon, 277-0825
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Fukuoka, Japon, 815-8555
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Fukuoka, Japon, 830-8543
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Hyōgo, Japon, 661-0002
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Kanagawa, Japon, 247-0056
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Kanagawa, Japon, 235-0045
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Kumamoto, Japon, 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, Japon, 880-0034
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Naka, Japon, 311-0113
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Sapporo, Japon, 060-0001
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Sapporo, Japon, 060-0062
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Sasebo, Japon, 857-1195
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Sendai, Japon, 980-0021
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Tama, Japon, 206-0033
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Tokyo, Japon, 103-0027
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Tokyo, Japon, 1030002
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Tokyo, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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, Japon, 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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Jalisco, Mexique, 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, Mexique, 64460
- 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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Zapopan, Mexique, 45116
- 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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Zapopan, Mexique, 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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Caguas, Porto Rico, 00726
- Centro de Endocrinologia y Nutricion del Turabo
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Manati, Porto Rico, 00674
- Manati Center for Clinical Research Inc
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Ponce, Porto Rico, 00716
- Ponce School of Medicine CAIMED Center
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Ponce, Porto Rico, 00717-1332
- Research and Cardiovascular Corp.
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San Juan, Porto Rico, 00917
- GCM Medical Group PSC
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Malacky, Slovaquie, 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, Slovaquie, 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, Slovaquie, 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, Slovaquie, 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, Slovaquie, 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, Taïwan, 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, Taïwan, 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.
-
Taipei, Taïwan, 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.
-
Taipei, Taïwan, 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.
-
Yongkang, Taïwan, 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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Krnov, Tchéquie, 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.
-
Pardubice, Tchéquie, 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.
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Praha, Tchéquie, 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, Tchéquie, 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, Tchéquie, 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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California
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Fresno, California, États-Unis, 93720
- Valley Research
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La Mesa, California, États-Unis, 91942
- Diabetes and Endocrine Associates
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Lancaster, California, États-Unis, 93534
- First Valley Medical Group
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Los Angeles, California, États-Unis, 90057
- National Research Institute
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Santa Clarita, California, États-Unis, 91321
- Care Access Research
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Spring Valley, California, États-Unis, 91978
- Encompass Clinical Research
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Tustin, California, États-Unis, 92780
- University Clinical Investigators, Inc.
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Florida
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Cooper City, Florida, États-Unis, 33024
- ALL Medical Research, LLC
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Fort Lauderdale, Florida, États-Unis, 33312
- The Center For Diabetes & Endocrine Care
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Jacksonville, Florida, États-Unis, 32216
- East Coast Institute for Research
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New Port Richey, Florida, États-Unis, 34652
- Sun Coast Clinical Research, Inc
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Hawaii
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Honolulu, Hawaii, États-Unis, 96814
- East West Medical Institute
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Idaho
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Blackfoot, Idaho, États-Unis, 83221
- Elite Clinical Trials LLLP
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Boise, Idaho, États-Unis, 83704
- Northwest Clinical Trials
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Idaho Falls, Idaho, États-Unis, 83404
- Rocky Mountain Diabetes and Osteoporosis Center
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Illinois
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Springfield, Illinois, États-Unis, 62711
- Prairie Education And Research Cooperative
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Iowa
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West Des Moines, Iowa, États-Unis, 50265
- Iderc, P.L.C.
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- University of Kansas Medical Center
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Kansas City, Kansas, États-Unis, 66606
- Cotton O'Neil Diabetes and Endocrinology Center
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Nevada
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Las Vegas, Nevada, États-Unis, 89148
- Palm Research Center
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Las Vegas, Nevada, États-Unis, 89128
- Palm Research Center
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New York
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New York, New York, États-Unis, 10016
- Manhattan Medical Research
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Ohio
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Columbus, Ohio, États-Unis, 43213
- Aventiv Research
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Pennsylvania
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Beaver, Pennsylvania, États-Unis, 15009
- Heritage Valley Medical Group, Inc.
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Pittsburgh, Pennsylvania, États-Unis, 15224
- Partners in Nephrology & Endocrinology
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Texas
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Austin, Texas, États-Unis, 78731-4309
- Texas Diabetes and Endocrinology
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Austin, Texas, États-Unis, 78749
- Texas Diabetes and Endocrinology-Austin South
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Dallas, Texas, États-Unis, 75230
- Dallas Diabetes Endocrine Center
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Shavano Park, Texas, États-Unis, 78231
- Consano Clinical Research
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Utah
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Bountiful, Utah, États-Unis, 84010
- Progressive Clinical Research
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Washington
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Federal Way, Washington, États-Unis, 98003
- Private: Dr. Larry Stonesifer
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Renton, Washington, États-Unis, 98057
- Rainier Clinical Research Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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 administré
Autres noms:
SC administré
SC administré
Administré par voie orale.
Administered orally.
|
Comparateur actif: 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 administré
SC administré
Administré par voie orale.
SC administré
Autres noms:
Administered orally.
|
Expérimental: 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 administré
Autres noms:
SC administré
SC administré
Administré par voie orale.
Administered orally.
|
Comparateur actif: 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 administré
SC administré
Administré par voie orale.
SC administré
Autres noms:
Administered orally.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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%
Délai: Week 26
|
Number of participants with HbA1c <7% at Week 26.
|
Week 26
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies du système endocrinien
- Diabète sucré
- Diabète sucré, Type 2
- Agents hypoglycémiants
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Insuline
- Insuline, Globine Zinc
- Metformine
- Insuline Glargine
- Insuline Lispro
- Inhibiteurs du transporteur sodium-glucose 2
Autres numéros d'identification d'étude
- 16314
- I8B-MC-ITRN (Autre identifiant: Eli Lilly and Company)
- 2015-005357-12 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Diabète sucré de type 2
-
Bnai Zion Medical CenterInconnue
-
Jiangsu HengRui Medicine Co., Ltd.Complété
-
Asahi Kasei Pharma CorporationRecrutement
-
University of MinnesotaActif, ne recrute pasHypoglycémie | Diabète sucré de type 2États-Unis
-
University of Campania "Luigi Vanvitelli"ComplétéDiabète sucré de type 2Italie
-
University of LiverpoolAstraZeneca; Clinical Practice Research DatalinkActif, ne recrute pas
-
Regor Pharmaceuticals Inc.RésiliéDiabète sucré de type 2États-Unis
-
Charles Drew University of Medicine and ScienceNational Center for Research Resources (NCRR)Résilié
-
Population Health Research InstituteNovo Nordisk A/SComplétéDiabète sucré de type 2Canada
-
Northwell HealthPatient-Centered Outcomes Research InstituteComplétéDiabète sucré de type 2 | Diabète de type 2États-Unis
Essais cliniques sur LY900014
-
Eli Lilly and CompanyComplétéEn bonne santéSingapour
-
Eli Lilly and CompanyComplétéDiabète sucré, Type 2Singapour
-
Eli Lilly and CompanyComplété
-
Eli Lilly and CompanyComplété
-
Eli Lilly and CompanyComplété
-
Eli Lilly and CompanyComplétéDiabète sucré de type 1Canada, Allemagne
-
Eli Lilly and CompanyComplétéDiabète de type 1États-Unis
-
Eli Lilly and CompanyComplétéDiabète sucré, type 1Allemagne
-
Eli Lilly and CompanyComplété
-
Eli Lilly and CompanyComplété