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En studie av LY900014 hos deltakere med type 1-diabetes (PRONTO-T1D)

17. april 2020 oppdatert av: Eli Lilly and Company

En prospektiv, randomisert, dobbeltblind sammenligning av LY900014 med Insulin Lispro med en åpen postprandial LY900014-behandlingsgruppe, i kombinasjon med Insulin Glargine eller Insulin Degludec, hos voksne med type 1-diabetes PRONTO-T1D

Hovedformålet med denne studien er å evaluere effekten av studiemedisinen LY900014 sammenlignet med insulin lispro, både i kombinasjon med insulin glargin eller insulin degludec, hos voksne med type 1 diabetes (T1D).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1392

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1013AAB
        • 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.
      • Buenos Aires, Argentina, C1056ABJ
        • 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.
      • Caba, Argentina, C1179AAB
        • 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.
      • Caba, Argentina, C1180AAX
        • 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.
      • Ciudad Autonoma de Buenos Aire, Argentina, 1408
        • 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.
      • Ciudad Autonoma de Buenos Aire, Argentina, C1128AAF
        • 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.
      • Córdoba, Argentina, 5006
        • 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.
      • Córdoba, Argentina, 5000
        • 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
      • Mar del Plata, Argentina, B7600FZN
        • 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.
  • Australia
      • Box Hill, Australia, 3128
        • 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.
      • Geelong, Australia, 3220
        • 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.
      • Merewether, Australia, 2291
        • 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.
      • Oaklands Park, Australia, 5046
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
  • Brasil
      • São Paulo, Brasil, 01244-030
        • 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.
  • Den russiske føderasjonen
      • Arkhangel'sk, Den russiske føderasjonen, 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, Den russiske føderasjonen, 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, Den russiske føderasjonen, 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, Den russiske føderasjonen, 117036
        • 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, Den russiske føderasjonen, 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, Den russiske føderasjonen, 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, Den russiske føderasjonen, 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.
  • Forente stater
    • Alabama
      • Mobile, Alabama, Forente stater, 36608
        • Internal Medicine Center LLC
    • California
      • Concord, California, Forente stater, 94520
        • John Muir Physician Network Clinical Research Center
      • Escondido, California, Forente stater, 92025
        • AMCR Institute Inc
      • Fresno, California, Forente stater, 93720
        • Valley Endocrine, Fresno
      • Greenbrae, California, Forente stater, 94904
        • Marin Endocrine Associates
      • La Mesa, California, Forente stater, 91942
        • Diabetes and Endocrine Associates
      • Tustin, California, Forente stater, 92780
        • University Clinical Investigators, Inc.
      • Ventura, California, Forente stater, 93003
        • Coastal Metabolic Research Centre
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Barbara Davis Center for Childhood Diabetes
    • Florida
      • Fort Lauderdale, Florida, Forente stater, 33312
        • The Center For Diabetes & Endocrine Care
      • Jacksonville, Florida, Forente stater, 32204
        • East Coast Institute for Research
      • New Port Richey, Florida, Forente stater, 34652
        • Sun Coast Clinical Research, Inc
      • West Palm Beach, Florida, Forente stater, 33401
        • Metabolic Research Institute Inc.
    • Georgia
      • Atlanta, Georgia, Forente stater, 30318
        • Atlanta Diabetes Associates
      • Macon, Georgia, Forente stater, 31210
        • East Coast Institute for Research
      • Roswell, Georgia, Forente stater, 30076
        • Endocrine Research Solutions, Inc.
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96814
        • East West Medical Institute
    • Idaho
      • Boise, Idaho, Forente stater, 83704
        • Northwest Clinical Trials
      • Idaho Falls, Idaho, Forente stater, 83404
        • Rocky Mountain Diabetes and Osteoporosis Center
    • Illinois
      • Springfield, Illinois, Forente stater, 62711
        • Prairie Education and Research Cooperative
    • Iowa
      • West Des Moines, Iowa, Forente stater, 50265
        • Iderc, P.L.C.
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • University of Kansas Medical Center
      • Topeka, Kansas, Forente stater, 66606
        • Cotton O'Neil Diabetes and Endocrinology Center
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40503
        • Kentucky Diabetes Endocrinology Center
    • Massachusetts
      • Waltham, Massachusetts, Forente stater, 02453
        • MassResearch
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89148
        • Palm Research Center
      • Las Vegas, Nevada, Forente stater, 89128
        • Palm Research Center
    • New Hampshire
      • Nashua, New Hampshire, Forente stater, 03063
        • Southern New Hampshire Diabetes and Endocrinology
    • New York
      • New York, New York, Forente stater, 10016
        • Manhattan Medical Research
    • North Carolina
      • Greenville, North Carolina, Forente stater, 27843
        • Physicians East
      • Morehead City, North Carolina, Forente stater, 28557
        • Diabetes & Endocrinology Consultants PC
      • Wilmington, North Carolina, Forente stater, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Mentor, Ohio, Forente stater, 44060
        • Your Diabetes Endocrine Nutrition Group PC
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18103
        • Lehigh Valley Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15224
        • Partners in Nephrology & Endocrinology
    • Rhode Island
      • Warwick, Rhode Island, Forente stater, 02886
        • Sudir Bansal M.D. Inc.
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37411
        • University Diabetes and Endocrine Consultants
    • Texas
      • Austin, Texas, Forente stater, 78731-4309
        • Texas Diabetes and Endocrinology
      • Dallas, Texas, Forente stater, 75230
        • Dallas Diabetes Endocrine Center
      • Round Rock, Texas, Forente stater, 78681
        • Texas Diabetes and Endocrinology, P.A.
      • Shavano Park, Texas, Forente stater, 78231
        • Consano Clinical Research
    • Utah
      • Bountiful, Utah, Forente stater, 84010
        • Progressive Clinical Research
    • Washington
      • Federal Way, Washington, Forente stater, 98003
        • Private: Dr. Larry Stonesifer
      • Renton, Washington, Forente stater, 98057
        • Rainier Clinical Research Center
  • Hellas
      • Ampelókipoi, Hellas, 11527
        • 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.
      • Athens, Hellas, 11527
        • 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.
      • Athens, Hellas, 17562
        • 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.
      • Lárisa, Hellas, 41110
        • 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.
      • Thessaloníki, Hellas, 54642
        • 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.
      • Thessaloníki, Hellas, 54645
        • 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.
      • Thessaloníki, Hellas, 57010
        • 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.
      • Thérmi, Hellas, 57001
        • "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."
  • India
      • Ahmedabad, India, 380015
        • 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.
      • Hyderabad, India, 500001
        • 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.
      • Hyderabad, India, 500035
        • 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.
      • Hyderabad, India, 500072
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Indore, India, 452002
        • 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.
      • Pune, India, 411001
        • 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.
      • Secunderabad, India, 500033
        • 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.
      • Visakhapatnam, India, 530002
        • 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.
  • Italia
      • Milano, Italia, 20132
        • 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.
      • Ravenna, Italia, 48121
        • 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.
      • Roma, Italia, 00161
        • 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.
      • Siena, Italia, 53100
        • 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.
  • Japan
      • Amagasaki, Japan, 661
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Fukuoka, Japan, 815-0071
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Fukuoka, Japan, 815-8555
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Kamakura, Japan, 247-0056
        • 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.
      • Kanagawa, Japan, 235-0045
        • "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."
      • Kumamoto, Japan, 862-0976
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Miyazaki, Japan, 880-0034
        • 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.
      • Naka, Japan, 311-0113
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Sapporo, Japan, 060-0001
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sapporo, Japan, 060-0062
        • 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.
      • Sasebo, Japan, 857-1195
        • 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.
      • Shinjuku, Japan, 162-8666
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Tokyo, Japan, 1030002
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Tokyo, Japan, 143-0015
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Tokyo, Japan, 160 0022
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tokyo, Japan, 206-0033
        • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
      • Ōita, Japan, 870-0039
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ōsaka, Japan, 545-8586
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ōsaka, Japan, 569-1096
        • 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.
  • Mexico
      • Guadalajara, Mexico, 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."
      • Monterrey, Mexico, 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.
      • Monterrey, Mexico, 64710
        • "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."
      • Zapopan, Mexico, 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.
  • New Zealand
      • Auckland, New Zealand, 2025
        • "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."
      • Christchurch, New Zealand, 8011
        • 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.
      • Wellington, New Zealand, 6021
        • 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.
    • Auckland
      • Takapuna, Auckland, New Zealand, 0620
        • 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.
  • Polen
      • Gdańsk, Polen, 80-546
        • 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.
      • Kraków, Polen, 31-500
        • 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.
      • Lublin, Polen, 20-333
        • 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.
      • Lublin, Polen, 20-538
        • "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."
      • Ruda Śląska, Polen, 41-709
        • 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.
      • Szczecin, Polen, 70-376
        • 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.
      • Szczecin, Polen, 70-506
        • 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.
      • Warsaw, Polen, 01-518
        • 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.
      • Warszawa, Polen, 02-507
        • 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.
      • Wrocław, Polen, 50-403
        • 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.
      • Łódź, Polen, 90-132
        • 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.
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Advanced Clinical Research, LLC
      • Bayamon, Puerto Rico, 00956
        • Dr Altagracia Aurora Alcantara Gonzalez
      • Manati, Puerto Rico, 00674
        • Manati Center for Clinical Research Inc
      • San Juan, Puerto Rico, 00921
        • Martha Gomez Cuellar M.D.
      • Yabucoa, Puerto Rico, 00767
        • Centro de Endocrinologia del Este
  • Romania
      • Bacău, Romania, 600164
        • 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.
      • Braşov, Romania, 500283
        • 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.
      • Bucuresti, Romania, 013682
        • 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.
      • Lasi, Romania, 700547
        • 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.
      • Oradea, Romania, 410025
        • 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.
      • Ploieşti, Romania, 100163
        • 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.
      • Ploieşti, Romania, 100342
        • 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.
      • Satu Mare, Romania, 440055
        • 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.
      • Timişoara, Romania, 300456
        • 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.
      • Târgu-Mureş, Romania, 540098
        • 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
      • Košice, 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.
      • Malacky, Slovakia, 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.
      • Nové Mesto nad Váhom, 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.
      • Rožňava, Slovakia, 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.
  • Spania
      • Málaga, Spania, 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.
      • Sevilla, Spania, 41071
        • 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.
      • Sevilla, Spania, 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.
      • Sevilla, Spania, 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."
      • Teruel, Spania, 44002
        • 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.
    • Barcelona
      • Sabadell, Barcelona, Spania, 08208
        • 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.
    • Valencia
      • Alcira, Valencia, Spania, 46600
        • 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.
  • Sverige
      • Göteborg, Sverige, 41345
        • 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.
      • Linköping, Sverige, 581 85
        • 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.
      • Lund, Sverige, 22185
        • 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.
      • Stockholm, Sverige, 14186
        • 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
      • Chang-hua, Taiwan, 500
        • 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.
      • Taichung, Taiwan, 40447
        • 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.
      • 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.
      • Tainan, Taiwan, 704
        • 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.
      • 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.
  • Tyskland
      • Bad Mergentheim, Tyskland, 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.
      • Falkensee, Tyskland, 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.
      • Hamburg, Tyskland, 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.
      • Hessen, Tyskland, 35415
        • 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.
      • Magdeburg, Tyskland, 39112
        • 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.
      • Mayen, Tyskland, 56727
        • 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.
      • Münster, Tyskland, 48145
        • 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.
      • Oldenburg, Tyskland, 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.
      • Rheine, Tyskland, 67059
        • 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.
      • Saterland, Tyskland, 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.
  • Østerrike
      • Graz, Østerrike, 8036
        • 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.
      • Graz, Østerrike, 1060
        • 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.
      • Wien, Østerrike, 1030
        • 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.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (VOKSEN, OLDER_ADULT)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inklusjonskriterier:

  • Ha T1D i minst 1 år før screening og kontinuerlig bruk av insulin i minst 1 år.
  • HbA1c på ≥7,0 og ≤9,5 %.
  • Bruk insulin lispro, insulin aspart eller insulin glulisin som prandial insulin.
  • Bruk insulin glargin, insulin detemir, insulin degludec eller nøytral protamin Hagedorn (NPH) insulin som basal insulin.

Ekskluderingskriterier:

  • Har brukt andre antihyperglykemiske medisiner eller terapier (inhalert, oralt eller injiserbart) innen 90 dager etter screening.
  • Har hatt mer enn 1 alvorlig hypoglykemisk episode innen 6 måneder etter screening.
  • Har hatt mer enn 1 sykehusinnleggelse relatert til hyperglykemi eller diabetisk ketoacidose innen 6 måneder etter screening.
  • Har klinisk signifikant gastrointestinal sykdom.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: BEHANDLING
  • Tildeling: TILFELDIG
  • Intervensjonsmodell: PARALLELL
  • Masking: DOBBELT

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
EKSPERIMENTELL: LY900014
LY900014 gitt subkutant (SC) 0-2 minutter før hvert måltid med enten basal insulin glargin gitt SC én eller to ganger daglig eller insulin degludec gitt SC én gang daglig. Preprandiale insulindoser ble individualisert og titrert i henhold til protokolldefinerte mål.
Legemiddel: LY900014
Administrert SC
Andre navn:
  • Ultra-Rapid Lispro
Legemiddel: Insulin Glargine
Administrert SC
Legemiddel: Insulin Degludec
Administrert SC
ACTIVE_COMPARATOR: Insulin Lispro (Humalog)
Insulin lispro gitt SC 0-2 minutter før hvert måltid med enten basal insulin glargin gitt SC en eller to ganger daglig eller insulin degludec gitt SC en gang daglig. Preprandiale insulindoser ble individualisert og titrert i henhold til protokolldefinerte mål.
Legemiddel: Insulin Glargine
Administrert SC
Legemiddel: Insulin Degludec
Administrert SC
Legemiddel: Insulin Lispro
Administrert SC
Andre navn:
  • Humalog
EKSPERIMENTELL: LY900014 Postmeal (Åpen etikett)
LY900014 gitt SC 20 minutter etter starten av hvert måltid med enten basal insulin glargin gitt SC en eller to ganger daglig eller insulin degludec gitt SC en gang daglig. Prandiale insulindoser ble individualisert og titrert i henhold til protokolldefinerte mål.
Legemiddel: LY900014
Administrert SC
Andre navn:
  • Ultra-Rapid Lispro
Legemiddel: Insulin Glargine
Administrert SC
Legemiddel: Insulin Degludec
Administrert SC
EKSPERIMENTELL: LY900014 – Maksimal utvidet påmelding (MEE)
LY900014 gitt subkutant (SC) 0-2 minutter før hvert måltid med enten basal insulin glargin gitt SC én eller to ganger daglig eller insulin degludec gitt SC én gang daglig. Preprandiale insulindoser ble individualisert og titrert i henhold til protokolldefinerte mål.
Legemiddel: LY900014
Administrert SC
Andre navn:
  • Ultra-Rapid Lispro
Legemiddel: Insulin Glargine
Administrert SC
Legemiddel: Insulin Degludec
Administrert SC
ACTIVE_COMPARATOR: Insulin Lispro (Humalog)-MEE
Insulin lispro gitt SC 0-2 minutter før hvert måltid med enten basal insulin glargin gitt SC en eller to ganger daglig eller insulin degludec gitt SC en gang daglig. Preprandiale insulindoser ble individualisert og titrert i henhold til protokolldefinerte mål.
Legemiddel: Insulin Glargine
Administrert SC
Legemiddel: Insulin Degludec
Administrert SC
Legemiddel: Insulin Lispro
Administrert SC
Andre navn:
  • Humalog
EKSPERIMENTELL: LY900014 Postmeal (Open Label)-MEE
LY900014 gitt SC 20 minutter etter starten av hvert måltid med enten basal insulin glargin gitt SC en eller to ganger daglig eller insulin degludec gitt SC en gang daglig. Prandiale insulindoser ble individualisert og titrert i henhold til protokolldefinerte mål.
Legemiddel: LY900014
Administrert SC
Andre navn:
  • Ultra-Rapid Lispro
Legemiddel: Insulin Glargine
Administrert SC
Legemiddel: Insulin Degludec
Administrert SC

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endring fra baseline i hemoglobin A1c (HbA1c) effektivitetsestimat ved uke 26
Tidsramme: Baseline, uke 26

HbA1c er den glykosylerte fraksjonen av hemoglobin A. HbA1c måles for å identifisere gjennomsnittlig plasmaglukosekonsentrasjon over lengre tidsperioder.

Minste kvadraters (LS)-gjennomsnitt ble bestemt ved en modell med gjentatte målinger (MMRM) med strata (samlet land, type basalinsulin, prandial insulindoseringsplan og HbA1c-stratum) og behandling som faste effekter og baseline som en kovariat. Effektestimatet inkluderte deltakerdata når baseline og minst én post-baseline-måling var tilgjengelig før permanent seponering av studiemedikamentet.
Baseline, uke 26

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endring fra baseline i 1-times postprandial glukose (PPG) ekskursjon under toleransetest for blandet måltid (MMTT) Effektestimat ved uke 26
Tidsramme: Baseline, uke 26
En standardisert MMTT ble brukt for å karakterisere postprandial glukosekontroll etter administrering av studieinsulin. Serumglukose målt 1 time etter måltidets start minus fastende serumglukose. 1-times PPG-ekskursjon under MMTT bruker ANCOVA-modellen med strata (samlet land, type basalinsulin, prandial insulindoseringsplan og HbA1c-stratum) og behandling som faste effekter og baseline som en kovariat. Effektestimatet inkluderte deltakerdata når baseline og minst én post-baseline-måling var tilgjengelig før permanent seponering av studiemedikamentet.
Baseline, uke 26
Endring fra baseline i 2-timers PPG-ekskursjon under MMTT-effektivitetsvurdering ved uke 26
Tidsramme: Baseline, uke 26
En standardisert MMTT ble brukt for å karakterisere postprandial glukosekontroll etter administrering av studieinsulin. Serumglukose målt 2 timer etter måltidets start minus fastende serumglukose. 2-timers PPG-ekskursjon under MMTT bruker ANCOVA-modellen med strata (samlet land, type basalinsulin, prandial insulindoseringsplan og HbA1c-stratum) og behandling som faste effekter og baseline som en kovariat. Effektestimatet inkluderte deltakerdata når baseline og minst én post-baseline-måling var tilgjengelig før permanent seponering av studiemedikamentet.
Baseline, uke 26
Hyppighet av alvorlig hypoglykemi ved uke 26
Tidsramme: Baseline til og med uke 26
Alvorlig hypoglykemi er definert som en hendelse som krever assistanse fra en annen person for å administrere karbohydrater, glukagon eller andre gjenopplivningshandlinger. I løpet av disse episodene har deltakeren en endret mental status og kan ikke hjelpe til i sin egen omsorg, eller kan være halvbevisst eller bevisstløs, eller oppleve koma med eller uten anfall, og kan kreve parenteral terapi. Frekvensen av alvorlige hypoglykemihendelser per 100 år i løpet av en definert periode ble beregnet ved totalt antall alvorlige hypoglykemiepisoder i perioden delt på de kumulative dagene på behandling fra alle deltakerne i en behandlingsgruppe *36525.
Baseline til og med uke 26
Hyppighet av dokumentert symptomatisk hypoglykemi ved uke 26
Tidsramme: Baseline til og med uke 26
Dokumentert symptomatisk hypoglykemi er en hendelse der typiske symptomer på hypoglykemi er ledsaget av blodsukker (BG) på <54 mg/dL [3,0 millimol per liter (mmol/L)]. Hyppigheten av dokumentert symptomatisk hypoglykemi ble estimert ved negativ binomial modell: antall episoder = behandling med log (behandlingseksponering i dager/365,25) som en offsetvariabel.
Baseline til og med uke 26
Endring fra baseline i 1,5-anhydroglucitol (1,5-AG) ved uke 26
Tidsramme: Baseline, uke 26
1,5-anhydroglucitol (1,5-AG) er en markør for kortsiktig glykemisk kontroll, spesielt postprandial hyperglykemi. 1,5-AG forutsier nøyaktig raske endringer i glykemi og er tett assosiert med glukosesvingninger og postprandial glukose. LS-gjennomsnitt ble beregnet ved bruk av gjentatte målinger av blandet modell (MMRM) inkludert faste klasseeffekter av behandling, strata (sammenslått land, type basalinsulin, HbA1c-stratum og antall prandiale doser ved studiestart), besøk og interaksjon mellom behandling og besøk. , så vel som de kontinuerlige, faste kovariatene til grunnlinjeverdien. Analysen inkluderte data samlet inn før permanent seponering av studiemedikamentet.
Baseline, uke 26
Endring fra baseline i 10-punkts selvovervåkende blodsukkerverdier (SMBG) ved uke 26
Tidsramme: Baseline, uke 26
SMBG 10-punkts profiler ble målt ved faste, 1 time etter morgenmåltid, 2 timer etter morgenmåltid, før middagsmåltid, 1 time etter middagsmåltid, 2 timer etter middagsmåltid, før kveldsmåltid, 1 time etter middag. kveldsmåltid, 2 timer etter kveldsmåltid og leggetid. LS-gjennomsnitt ble analysert ved bruk av gjentatte målinger med blandede modeller (MMRM) inkludert faste klasseeffekter av behandling, strata (sammenslått land, type basalinsulin, HbA1c-stratum og antall prandiale doser ved studiestart), besøk og interaksjon mellom behandling og besøk. , så vel som de kontinuerlige, faste kovariatene til grunnlinjeverdien. Effektestimatet inkluderte deltakerdata ved baseline og minst én post-baseline-måling før permanent seponering av studiemedikamentet.
Baseline, uke 26
Endring fra baseline i insulindose ved uke 26
Tidsramme: Baseline, uke 26
LS-gjennomsnitt ble analysert ved bruk av gjentatte målinger med blandede modeller (MMRM) inkludert faste klasseeffekter av behandling, strata (sammenslått land, type basalinsulin, HbA1c-stratum og antall prandiale doser ved studiestart), besøk og interaksjon mellom behandling og besøk. , så vel som de kontinuerlige, faste kovariatene til grunnlinjeverdien. Analysen inkluderte data før permanent seponering av studiemedikamentet.
Baseline, uke 26
Endring fra baseline i Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score ved uke 26
Tidsramme: Baseline, uke 26
ITSQ er et validert instrument som inneholder 22 elementer som vurderer behandlingstilfredshet for deltakere med diabetes og insulin. Spørreskjemaet måler tilfredshet fra følgende 5 domener: Besvær med regimet, livsstilsfleksibilitet, glykemisk kontroll, hypoglykemisk kontroll og insulintilførselsenhet. Data presentert er den transformerte totalskåren på en skala fra 0-100, hvor høyere skår indikerer bedre behandlingstilfredshet. LS Mean ble beregnet ved bruk av ANCOVA-modellen med strata (samlet land, type basalinsulin, antall prandiale doser ved studiestart og HbA1c-stratum), og behandling som faste effekter og baseline som kovariat. Analysen inkluderte data før permanent seponering av studiemedikamentet. Analysen inkluderte data før permanent seponering av studiemedikamentet.
Baseline, uke 26
Endring fra baseline i ITSQ Lifestyle Flexibility Domain-poengsum ved uke 26
Tidsramme: Baseline, uke 26
ITSQ er et validert instrument som inneholder 22 elementer som vurderer behandlingstilfredshet for deltakere med diabetes og insulin. Spørreskjemaet måler tilfredshet fra følgende 5 domener: Besvær med regimet, livsstilsfleksibilitet, glykemisk kontroll, hypoglykemisk kontroll og insulintilførselsenhet. Data presentert er den transformerte totalskåren på en skala fra 0-100, hvor høyere skår indikerer bedre behandlingstilfredshet. LS Mean ble beregnet ved å bruke analysen av kovarians (ANCOVA) med strata (samlet land, type basalinsulin, antall prandiale doser ved studiestart og HbA1c-stratum), og behandling som faste effekter og baseline som kovariant. Analysen inkluderte data før permanent seponering av studiemedikamentet. Analysen inkluderte data før permanent seponering av studiemedikamentet.
Baseline, uke 26
Prosentandel av deltakere med HbA1c <7 %
Tidsramme: Uke 26
Hemoglobin A1c (HbA1c) er den glykosylerte fraksjonen av hemoglobin A. HbA1c måles for å identifisere gjennomsnittlig plasmaglukosekonsentrasjon over lengre tidsperioder.
Uke 26
Endring fra baseline i HbA1c ved uke 52
Tidsramme: Grunnlinje, uke 52

HbA1c er den glykosylerte fraksjonen av hemoglobin A. HbA1c måles for å identifisere gjennomsnittlig plasmaglukosekonsentrasjon over lengre tidsperioder.

Gjennomsnitt av minste kvadrater (LS) ble bestemt av MMRM-modellen med variabler for baseline, sammenslått land, type basalinsulin under innføring, prandial insulindoseringsplan, behandling (type III sum av kvadrater) som faste faktorer. Analysen inkluderte data før permanent seponering av studiemedikamentet.
Grunnlinje, uke 52

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eli Lilly and Company

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (FAKTISKE)

17. juli 2017

Primær fullføring (FAKTISKE)

6. september 2018

Studiet fullført (FAKTISKE)

22. august 2019

Datoer for studieregistrering

Først innsendt

10. juli 2017

Først innsendt som oppfylte QC-kriteriene

10. juli 2017

Først lagt ut (FAKTISKE)

11. juli 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (FAKTISKE)

1. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. april 2020

Sist bekreftet

1. september 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 16313
  • I8B-MC-ITRM (ANNEN: Eli Lilly and Company)
  • 2015-005356-99 (EUDRACT_NUMBER)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserte individuelle pasientnivådata vil bli gitt i et sikkert tilgangsmiljø ved godkjenning av et forskningsforslag og en signert datadelingsavtale.

IPD-delingstidsramme

Data er tilgjengelig 6 måneder etter den primære publisering og godkjenning av indikasjonen studert i USA og EU, avhengig av hva som er senere. Data vil være tilgjengelig på ubestemt tid for forespørsel.

Tilgangskriterier for IPD-deling

Et forskningsforslag må godkjennes av et uavhengig granskningspanel og forskere må signere en datadelingsavtale.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Type 1 diabetes mellitus

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