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A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (PRONTO-T2D)

torstai 12. maaliskuuta 2020 päivittänyt: 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).

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

933

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Argentiina
    • Buenos Aires
      • Caba, Buenos Aires, Argentiina, 1425
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      • Caba, Buenos Aires, Argentiina, C1013AAB
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      • Caba, Buenos Aires, Argentiina, C1179AAB
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      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentiina, 1408
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      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentiina, C1056ABJ
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      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentiina, C1204AAD
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      • Mar del Plata, Buenos Aires, Argentiina, B7600FZN
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  • Australia
    • South Australia
      • Keswick, South Australia, Australia, 5035
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      • Oaklands Park, South Australia, Australia, 5046
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    • Victoria
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      • Geelong, Victoria, Australia, 3220
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    • Western Australia
      • Fremantle, Western Australia, Australia, 6959
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  • Espanja
      • Lleida, Espanja, 25198
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      • Málaga, Espanja, 29006
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      • Sevilla, Espanja, 41010
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      • Sevilla, Espanja, 41003
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  • Intia
    • Gujarat
      • Ahmedabad, Gujarat, Intia, 380015
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      • Ahmedabad, Gujarat, Intia, 380015
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      • Ahmedabad, Gujarat, Intia, 380016
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    • Karnataka
      • Bangalore, Karnataka, Intia, 560017
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      • Bangalore, Karnataka, Intia, 560054
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    • Maharashtra
      • Pune, Maharashtra, Intia, 411004
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      • Pune, Maharashtra, Intia, 411011
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    • Maharshtra
      • Mumbai, Maharshtra, Intia, 400012
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    • Rajasthan
      • Jaipur, Rajasthan, Intia, 302017
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    • Tamil Nadu
      • Chennai, Tamil Nadu, Intia, 600086
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    • Telangana
      • Hyderabad, Telangana, Intia, 500012
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      • Hyderabad, Telangana, Intia, 500072
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  • Italia
      • Palmero, Italia, 90127
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      • Sesto San Giovanni, Italia, 20099
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  • Japani
      • Chiba, Japani, 277-0825
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      • Fukuoka, Japani, 815-8555
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      • Fukuoka, Japani, 830-8543
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      • Hyōgo, Japani, 661-0002
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      • Kanagawa, Japani, 247-0056
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      • Kanagawa, Japani, 235-0045
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      • Kumamoto, Japani, 862-0976
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      • Miyazaki, Japani, 880-0034
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      • Naka, Japani, 311-0113
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      • Sapporo, Japani, 060-0001
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      • Sapporo, Japani, 060-0062
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      • Sasebo, Japani, 857-1195
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      • Sendai, Japani, 980-0021
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      • Tama, Japani, 206-0033
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      • Tokyo, Japani, 103-0027
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      • Tokyo, Japani, 1030002
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      • Tokyo, Japani, 160 0022
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      • Tokyo, Japani, 143-0015
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      • Yamato, Japani, 242-0004
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      • Ōita, Japani, 870-0039
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      • Ōsaka, Japani, 530-0001
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      • Ōsaka, Japani, 534-0021
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  • Korean tasavalta
      • Ansan-si, Korean tasavalta, 15355
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      • Daegu, Korean tasavalta, 41931
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      • Daejeon, Korean tasavalta, 35233
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      • Gangwon-do, Korean tasavalta, 24289
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      • Gangwon-do, Korean tasavalta, 26426
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      • Seoul, Korean tasavalta, 06351
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      • Seoul, Korean tasavalta, 03181
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      • Seoul, Korean tasavalta, 02841
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      • Seoul, Korean tasavalta, 05278
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      • Seoul, Korean tasavalta, 06591
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      • Seoul, Korean tasavalta, 07061
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      • Seoul, Korean tasavalta, 01830
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      • Seoul, Korean tasavalta, 08308
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    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korean tasavalta, 14647
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  • Meksiko
      • Jalisco, Meksiko, 44650
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      • Monterrey, Meksiko, 64460
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      • Zapopan, Meksiko, 45116
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      • Zapopan, Meksiko, 45030
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  • Puerto Rico
      • Caguas, Puerto Rico, 00726
        • Centro de Endocrinologia y Nutricion del Turabo
      • Manati, Puerto Rico, 00674
        • Manati Center for Clinical Research Inc
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine CAIMED Center
      • Ponce, Puerto Rico, 00717-1332
        • Research and Cardiovascular Corp.
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group PSC
  • Saksa
      • Hamburg, Saksa, 22607
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    • Baden-Württemberg
      • Bad Mergentheim, Baden-Württemberg, Saksa, 97980
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    • Brandenburg
      • Falkensee, Brandenburg, Saksa, 14612
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    • Hessen
      • Pohlheim, Hessen, Saksa, 35415
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    • Nordrhein-Westfalen
      • Münster, Nordrhein-Westfalen, Saksa, 48145
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    • Rheinland-Pfalz
      • Mayen, Rheinland-Pfalz, Saksa, 56727
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    • Saarland
      • Saint Ingbert-Oberwürzbach, Saarland, Saksa, 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.
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Saksa, 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.
    • Schleswig-Holstein
      • Oldenburg, Schleswig-Holstein, Saksa, 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.
  • Slovakia
      • Malacky, Slovakia, 90101
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      • Nove Mesto nad Vahom, Slovakia, 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.
      • Púchov, Slovakia, 02001
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      • Rožňava, Slovakia, 048 01
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    • Slovak Republic
      • Košice, Slovak Republic, Slovakia, 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.
  • Taiwan
      • Taichung, Taiwan, 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.
      • Taipei, Taiwan, 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, Taiwan, 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, Taiwan, 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, Taiwan, 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.
  • Tšekki
      • Krnov, Tšekki, 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, Tšekki, 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, Tšekki, 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, Tšekki, 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, Tšekki, 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.
  • Unkari
      • Budapest, Unkari, 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.
      • Budapest, Unkari, 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.
      • Budapest, Unkari, 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
      • Nagykanizsa, Unkari, 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.
  • Venäjän federaatio
      • Arkhangel'sk, Venäjän federaatio, 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.
      • Kursk, Venäjän federaatio, 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.
      • Moscow, Venäjän federaatio, 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.
      • Moscow, Venäjän federaatio, 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.
      • Saint Petersburg, Venäjän federaatio, 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.
      • Saratov, Venäjän federaatio, 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.
  • Yhdysvallat
    • California
      • Fresno, California, Yhdysvallat, 93720
        • Valley Research
      • La Mesa, California, Yhdysvallat, 91942
        • Diabetes and Endocrine Associates
      • Lancaster, California, Yhdysvallat, 93534
        • First Valley Medical Group
      • Los Angeles, California, Yhdysvallat, 90057
        • National Research Institute
      • Santa Clarita, California, Yhdysvallat, 91321
        • Care Access Research
      • Spring Valley, California, Yhdysvallat, 91978
        • Encompass Clinical Research
      • Tustin, California, Yhdysvallat, 92780
        • University Clinical Investigators, Inc.
    • Florida
      • Cooper City, Florida, Yhdysvallat, 33024
        • ALL Medical Research, LLC
      • Fort Lauderdale, Florida, Yhdysvallat, 33312
        • The Center For Diabetes & Endocrine Care
      • Jacksonville, Florida, Yhdysvallat, 32216
        • East Coast Institute for Research
      • New Port Richey, Florida, Yhdysvallat, 34652
        • Sun Coast Clinical Research, Inc
    • Hawaii
      • Honolulu, Hawaii, Yhdysvallat, 96814
        • East West Medical Institute
    • Idaho
      • Blackfoot, Idaho, Yhdysvallat, 83221
        • Elite Clinical Trials LLLP
      • Boise, Idaho, Yhdysvallat, 83704
        • Northwest Clinical Trials
      • Idaho Falls, Idaho, Yhdysvallat, 83404
        • Rocky Mountain Diabetes and Osteoporosis Center
    • Illinois
      • Springfield, Illinois, Yhdysvallat, 62711
        • Prairie Education And Research Cooperative
    • Iowa
      • West Des Moines, Iowa, Yhdysvallat, 50265
        • Iderc, P.L.C.
    • Kansas
      • Kansas City, Kansas, Yhdysvallat, 66160
        • University Of Kansas Medical Center
      • Kansas City, Kansas, Yhdysvallat, 66606
        • Cotton O'Neil Diabetes and Endocrinology Center
    • Nevada
      • Las Vegas, Nevada, Yhdysvallat, 89148
        • Palm Research Center
      • Las Vegas, Nevada, Yhdysvallat, 89128
        • Palm Research Center
    • New York
      • New York, New York, Yhdysvallat, 10016
        • Manhattan Medical Research
    • Ohio
      • Columbus, Ohio, Yhdysvallat, 43213
        • Aventiv Research
    • Pennsylvania
      • Beaver, Pennsylvania, Yhdysvallat, 15009
        • Heritage Valley Medical Group, Inc.
      • Pittsburgh, Pennsylvania, Yhdysvallat, 15224
        • Partners in Nephrology & Endocrinology
    • Texas
      • Austin, Texas, Yhdysvallat, 78731-4309
        • Texas Diabetes and Endocrinology
      • Austin, Texas, Yhdysvallat, 78749
        • Texas Diabetes and Endocrinology-Austin South
      • Dallas, Texas, Yhdysvallat, 75230
        • Dallas Diabetes Endocrine Center
      • Shavano Park, Texas, Yhdysvallat, 78231
        • Consano Clinical Research
    • Utah
      • Bountiful, Utah, Yhdysvallat, 84010
        • Progressive Clinical Research
    • Washington
      • Federal Way, Washington, Yhdysvallat, 98003
        • Private: Dr. Larry Stonesifer
      • Renton, Washington, Yhdysvallat, 98057
        • Rainier Clinical Research Center

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Lääke: LY900014
Annettu SC
Muut nimet:
  • Erittäin nopea Lispro
Lääke: Glargine-insuliini
Annettu SC
Lääke: Insuliini Degludec
Annettu SC
Lääke: Metformiini
Annostetaan suun kautta.
Lääke: SGLT2 inhibitor
Administered orally.
Active Comparator: 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.
Lääke: Glargine-insuliini
Annettu SC
Lääke: Insuliini Degludec
Annettu SC
Lääke: Metformiini
Annostetaan suun kautta.
Lääke: Insuliini Lispro
Annettu SC
Muut nimet:
  • Humalog
Lääke: SGLT2 inhibitor
Administered orally.
Kokeellinen: 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.
Lääke: LY900014
Annettu SC
Muut nimet:
  • Erittäin nopea Lispro
Lääke: Glargine-insuliini
Annettu SC
Lääke: Insuliini Degludec
Annettu SC
Lääke: Metformiini
Annostetaan suun kautta.
Lääke: SGLT2 inhibitor
Administered orally.
Active Comparator: 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.
Lääke: Glargine-insuliini
Annettu SC
Lääke: Insuliini Degludec
Annettu SC
Lääke: Metformiini
Annostetaan suun kautta.
Lääke: Insuliini Lispro
Annettu SC
Muut nimet:
  • Humalog
Lääke: SGLT2 inhibitor
Administered orally.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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%
Aikaikkuna: Week 26
Number of participants with HbA1c <7% at Week 26.
Week 26

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Eli Lilly and Company

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 14. heinäkuuta 2017

Ensisijainen valmistuminen (Todellinen)

Tiistai 14. elokuuta 2018

Opintojen valmistuminen (Todellinen)

Keskiviikko 13. maaliskuuta 2019

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 10. heinäkuuta 2017

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 10. heinäkuuta 2017

Ensimmäinen Lähetetty (Todellinen)

Tiistai 11. heinäkuuta 2017

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 27. maaliskuuta 2020

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 12. maaliskuuta 2020

Viimeksi vahvistettu

Torstai 15. elokuuta 2019

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 16314
  • I8B-MC-ITRN (Muu tunniste: Eli Lilly and Company)
  • 2015-005357-12 (EudraCT-numero)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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-jaon aikakehys

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-jaon käyttöoikeuskriteerit

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • CSR

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Tyypin 2 diabetes mellitus

Kliiniset tutkimukset LY900014

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Lithuania

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

Tilaa