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En studie hos pasienter med type 2 diabetes mellitus (IMAGINE 2)

16. mars 2018 oppdatert av: Eli Lilly and Company

En sammenligning av LY2605541 versus insulin Glargine som basal insulinbehandling i kombinasjon med orale antihyperglykemimedisiner hos insulinnaive pasienter med type 2 diabetes mellitus: en dobbeltblind, randomisert studie

Hensikten med denne studien er:

  • For å sammenligne blodsukkerkontroll på LY2605541 med insulin glargin etter 52 ukers behandling.
  • For å sammenligne frekvensen av episoder med lavt blodsukker om natten på LY2605541 med insulin glargin i løpet av 52 ukers behandling.
  • For å sammenligne antall deltakere på LY2605541 som når blodsukkermål uten episoder med lavt blodsukker om natten med de som tar insulin glargin etter 52 ukers behandling.
  • For å sammenligne frekvensen av episoder med lavt blodsukker på LY2605541 med insulin glargin etter 52 ukers behandling

Studieoversikt

Status

Fullført

Studietype

Intervensjonell

Registrering (Faktiske)

1538

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

      • Buenos Aires, Argentina, C1188AAF
        • 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.
      • Caba, Argentina, 2000
        • 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, X5000BNB
        • 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, B7600GNY
        • 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 South Wales
      • Merewether, New South Wales, Australia, 2291
        • 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.
    • South Australia
      • Keswick, South Australia, Australia, 5035
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • 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.
      • Marilia, Brasil, 17519-000
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      • Rio De Janeiro, Brasil, 22271-100
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      • Setor Oeste/Goiania, Brasil, 74100-120
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      • São Paulo, Brasil, 04266-010
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    • Alberta
      • Edmonton, Alberta, Canada, T5J 3N4
        • 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.
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • 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.
      • Victoria, British Columbia, Canada, V8V 3N7
        • 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.
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3P 3P4
        • 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.
    • Ontario
      • Etobicoke, Ontario, Canada, M9R 4E1
        • 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.
      • Markham, Ontario, Canada, L6B 0P9
        • 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.
      • Toronto, Ontario, Canada, M9W 4L6
        • 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.
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • 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.
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • 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.
      • Sherbrooke, Quebec, Canada, J1G 5K2
        • 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.
      • Cheboksary, Den russiske føderasjonen, 428000
        • 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.
      • Kazan, Den russiske føderasjonen, 420012
        • 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, 303035
        • 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.
      • Novosibirsk, Den russiske føderasjonen, 630091
        • 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, 193257
        • 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.
      • Oulu, Finland, 90100
        • 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.
      • Seinajoki, Finland, 60220
        • 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.
    • Alabama
      • Anniston, Alabama, Forente stater, 36207
        • 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.
      • Mobile, Alabama, Forente stater, 36608
        • 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.
    • Arizona
      • Chandler, Arizona, Forente stater, 85224
        • 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.
      • Mesa, Arizona, Forente stater, 85206
        • 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.
      • Tempe, Arizona, Forente stater, 85283
        • 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.
      • Tucson, Arizona, Forente stater, 85704
        • 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.
    • California
      • Concord, California, Forente stater, 94520
        • 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.
      • Escondido, California, Forente stater, 92026
        • 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.
      • Fresno, California, Forente stater, 93720
        • 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.
      • Greenbrae, California, Forente stater, 94904
        • 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.
      • Huntington Beach, California, Forente stater, 92648
        • 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.
      • Lancaster, California, Forente stater, 93534
        • 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.
      • Los Angeles, California, Forente stater, 90057
        • 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.
      • Mission Viejo, California, Forente stater, 92691
        • 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.
      • Northridge, California, Forente stater, 91324
        • 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.
      • Palm Springs, California, Forente stater, 92262
        • 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.
      • San Mateo, California, Forente stater, 94401
        • 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.
      • Tustin, California, Forente stater, 92780
        • 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.
    • Colorado
      • Denver, Colorado, Forente stater, 80246
        • 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.
    • Florida
      • Daytona Beach, Florida, Forente stater, 32117
        • 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.
      • Jacksonville, Florida, Forente stater, 32258
        • 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.
      • Tampa, Florida, Forente stater, 33619
        • 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.
      • Winter Haven, Florida, Forente stater, 33880
        • 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.
    • Georgia
      • Athens, Georgia, Forente stater, 30606
        • 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.
      • Atlanta, Georgia, Forente stater, 30338
        • 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.
      • Decatur, Georgia, Forente stater, 30033
        • 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.
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96814
        • 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.
    • Idaho
      • Idaho Falls, Idaho, Forente stater, 83404
        • 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.
      • Meridian, Idaho, Forente stater, 83646
        • 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.
    • Illinois
      • Chicago, Illinois, Forente stater, 60607
        • 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.
      • Springfield, Illinois, Forente stater, 62704
        • 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.
    • Iowa
      • West Des Moines, Iowa, Forente stater, 50266
        • 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.
    • Kansas
      • Topeka, Kansas, Forente stater, 66606
        • 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.
    • Louisiana
      • Shreveport, Louisiana, Forente stater, 71103
        • 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.
    • Maine
      • Bangor, Maine, Forente stater, 04401
        • 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.
    • Massachusetts
      • Haverhill, Massachusetts, Forente stater, 01830
        • 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.
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63141
        • 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.
    • Montana
      • Billings, Montana, Forente stater, 59102
        • 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 Hampshire
      • Nashua, New Hampshire, Forente stater, 03063
        • 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 Jersey
      • Toms River, New Jersey, Forente stater, 08753
        • 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.
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45236
        • 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.
      • Gallipolis, Ohio, Forente stater, 45631
        • 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.
      • Perrysburg, Ohio, Forente stater, 43551
        • 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.
    • Oregon
      • Corvallis, Oregon, Forente stater, 97330
        • 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.
      • Springfield, Oregon, Forente stater, 97477
        • 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.
    • Pennsylvania
      • Beaver, Pennsylvania, Forente stater, 15009
        • 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.
      • Downingtown, Pennsylvania, Forente stater, 19335
        • 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.
      • Lansdale, Pennsylvania, Forente stater, 19446
        • 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.
      • Levittown, Pennsylvania, Forente stater, 19056
        • 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.
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • 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.
      • Pottstown, Pennsylvania, Forente stater, 19464
        • 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.
    • South Carolina
      • Greer, South Carolina, Forente stater, 29651
        • 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.
      • Myrtle Beach, South Carolina, Forente stater, 29572
        • 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.
    • Tennessee
      • Bristol, Tennessee, Forente stater, 37620
        • 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.
      • Knoxville, Tennessee, Forente stater, 37912
        • 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.
      • Memphis, Tennessee, Forente stater, 38119
        • 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.
      • Spring Hill, Tennessee, Forente stater, 37174
        • 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.
    • Texas
      • Austin, Texas, Forente stater, 78758
        • 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.
      • Marshall, Texas, Forente stater, 75670
        • 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.
      • Sugar Land, Texas, Forente stater, 77478
        • 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.
    • Utah
      • Bountiful, Utah, Forente stater, 84010
        • 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.
      • Clinton, Utah, Forente stater, 84015
        • 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.
      • Ogden, Utah, Forente stater, 84403
        • 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.
    • Washington
      • Olympia, Washington, Forente stater, 98502
        • 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.
      • Port Orchard, Washington, Forente stater, 98366
        • 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.
      • Spokane, Washington, Forente stater, 99220
        • 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.
      • Ampelokipoi, 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 1-877-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.
      • Thessaloniki, Hellas, 56429
        • 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.
      • Beer Sheva, Israel, 84350
        • 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.
      • Haifa, Israel, 35251
        • 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.
      • Raanana, Israel, 43452
        • 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.
      • Carpi, Italia, 41012
        • 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.
      • Castellanza, Italia, 21053
        • 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.
      • Foggia, Italia, 71100
        • 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.
      • Forli, Italia, 47100
        • 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.
      • Rome, Italia, 00133
        • 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.
      • Sesto San Giovanni, Italia, 20099
        • 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.
      • Utena, Litauen, 28151
        • 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.
      • Vilnius, Litauen, LT-08661
        • 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.
      • Coatzacoalcos, Mexico, 96400
        • 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.
      • Mexico City, Mexico, 11550
        • 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, 64620
        • 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, New Zealand, 1640
        • 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.
      • Kamieniec Zabkowicki, Polen, 57-230
        • 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.
      • Katowice, Polen, 40-772
        • 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.
      • Krakow, Polen, 31-455
        • 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.
      • Lodz, Polen, 93-338
        • 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 Slaska, 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, 70-506
        • 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.
      • Tychy, Polen, 43-100
        • 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, 01-192
        • 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.
      • Hato Rey, Puerto Rico, 00917
        • 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.
      • Manati, Puerto Rico, 00674
        • 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.
      • San Juan, Puerto Rico, 00917-3104
        • 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.
      • Bucharest, Romania, 011234
        • 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.
      • Cluj-Napoca, Romania, 400006
        • 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.
      • Iasi, 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, 410169
        • 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.
      • Ploiesti, 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.
      • Resita, Romania, 320076
        • 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.
      • Targu-Mures, 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.
      • Bratislava, Slovakia, 82102
        • 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.
      • Sala, Slovakia, 92701
        • 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.
      • Vranov Nad Toplou, Slovakia, 09301
        • 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.
      • Alicante, Spania, 03114
        • 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.
      • Cordoba, Spania, 14004
        • 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.
      • Pozuelo De Alarcon, Spania, 28223
        • 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.
      • Requena, Spania, 46340
        • 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.
      • Seville, 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.
      • Toledo, Spania, 45004
        • 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.
    • Berks
      • Mortimer, Berks, Storbritannia, RG7 3SQ
        • 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.
    • Leicestershire
      • Leicester, Leicestershire, Storbritannia, LE5 4PW
        • 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.
    • Surrey
      • Guildford, Surrey, Storbritannia, GU2 7XX
        • 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.
    • Wales
      • Swansea, Wales, Storbritannia, SA6 6NL
        • 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.
      • Paarl, Sør-Afrika, 7646
        • 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.
      • Parow, Sør-Afrika, 7505
        • 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.
      • Somerset West, Sør-Afrika, 7130
        • 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.
      • Gaziantep, Tyrkia, 27070
        • 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.
      • Hatay, Tyrkia, 31040
        • 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.
      • Izmir, Tyrkia, 35340
        • 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.
      • Kayseri, Tyrkia, 38039
        • 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.
      • Dippoldiswalde, Tyskland, 01744
        • 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.
      • Dresden, Tyskland, 01307
        • 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.
      • Friedrichsthal, Tyskland, 66299
        • 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.
      • Furth Im Wald, Tyskland, 93437
        • 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.
      • Goch, Tyskland, 47574
        • 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.
      • Hamburg, Tyskland, D-22587
        • 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.
      • Ludwigshafen, 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.
      • Münster, Tyskland, 48143
        • 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.
      • Saarbrücken, Tyskland, 66121
        • 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.
      • Schweinfurt, Tyskland, 97421
        • 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.
      • Sulzbach, Tyskland, 92237
        • 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.
      • Budapest, Ungarn, H-1139
        • 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.
      • Debrecen, Ungarn, 4032
        • 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.
      • Mako, Ungarn, 6900
        • 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.
      • Salgotarjan, Ungarn, 3100
        • 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.
      • Sopron, Ungarn, 9400
        • 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.

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, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inklusjonskriterier:

  • Har type 2 diabetes mellitus, ikke behandlet med insulin, i minst 1 år før studien
  • Har mottatt minst 2 OAMs i minst 3 måneder før du gikk inn i studien
  • Ha en hemoglobin A1c (HbA1c) verdi mellom 7,0 % og 11,0 %, inklusive, ved screening
  • Er i stand til og villige til å injisere insulin med hetteglass og sprøyte og utføre selvkontroll av blodsukker
  • Kun kvinner i fertil alder: ammer ikke, har en negativ graviditetstest på tidspunktet for screening og randomisering, har til hensikt å ikke bli gravid under forsøket, har praktisert en pålitelig prevensjonsmetode i minst 6 uker før screening, og godta å bruke en pålitelig prevensjonsmetode under studien og inntil 2 uker etter siste dose av studiemedikamentet

Ekskluderingskriterier:

  • Har brukt insulinbehandling (utenom svangerskapet) når som helst de siste 2 årene, bortsett fra korttidsbehandling av akutte tilstander, og opptil maksimalt 4 sammenhengende uker
  • Bruk av rosiglitazon, pramlintide eller glukagon-lignende peptid 1 (GLP-1) reseptoragonist (for eksempel exenatid, exenatid en gang i uken eller liraglutid) samtidig eller innen 3 måneder før screening
  • Tar for tiden, eller har tatt i løpet av de 3 månedene før screening, medisiner for å fremme vekttap
  • Har hatt noen episoder med alvorlig hypoglykemi innen 6 måneder før screening
  • Har hatt 1 eller flere episoder med ketoacidose eller hyperosmolar tilstand/koma i løpet av de 6 månedene før studien
  • Har hjertesykdom med funksjonsstatus som er New York Heart Association klasse III eller IV (i henhold til New York Heart Association [NYHA] Cardiac Disease Classification)
  • Har en historie med nyretransplantasjon, eller får for tiden nyredialyse eller har serumkreatinin større eller lik 2 milligram per desiliter (mg/dL)
  • Har åpenbare kliniske tegn eller symptomer på leversykdom (unntatt ikke-alkoholisk fettleversykdom [NAFLD]), akutt eller kronisk hepatitt, ikke-alkoholisk steatohepatitt (NASH) eller forhøyede leverenzymmålinger ved screening
  • Har hatt blodoverføring eller alvorlig blodtap innen 3 måneder før screening eller har kjent hemoglobinopati, hemolytisk anemi eller sigdcelleanemi, eller andre trekk ved hemoglobinavvik som er kjent for å forstyrre målingen av HbA1c
  • Har aktiv eller ubehandlet malignitet eller har vært i remisjon fra klinisk signifikant malignitet i mindre enn 5 år
  • Ha fastende eller ikke-fastende triglyserider større enn 400 mg/dL (større enn 4,5 millimol per liter [mmol/L]) ved screening
  • Bruker lipidsenkende medisiner i en dose som ikke har vært stabil i 90 dager før screening
  • Bruker niacinpreparater som et lipidsenkende medikament og gallesyrebindere innen 90 dager før screening

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: LY2605541
LY2605541 titrert basert på blodsukkermålinger, administrert subkutant (SC), en gang daglig i kombinasjon med minst 2 pre-studie orale antihyperglykemiske medisiner (OAMs) foreskrevet av den personlige legen, i 52 eller 78 uker
Aktiv komparator: Glargine
Glargin titrert basert på blodsukkeravlesninger, administrert SC, en gang daglig i kombinasjon med minst 2 pre-studie OAMs foreskrevet av den personlige legen, i 52 eller 78 uker

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endring fra baseline til 52 ukers endepunkt i hemoglobin A1c (HbA1c)
Tidsramme: Utgangspunkt, 52 uker
HbA1C er en test som måler en persons gjennomsnittlige blodsukkernivå de siste 2 til 3 månedene. Minste kvadraters (LS) gjennomsnitt ble beregnet ved bruk av en blandet modell gjentatte mål (MMRM) med baseline HbA1c-måling, stratifiseringsfaktorer (land, lavdensitet lipoprotein-kolesterol [LDL-C, < 100 milligram per desiliter {mg/dL} og ≥ 100 mg/dL] og sulfonylurea [SU]/meglitinid bruk), besøk, behandling og besøk-for-behandling interaksjon som faste effekter.
Utgangspunkt, 52 uker

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hyppighet av totale og nattlige hypoglykemihendelser
Tidsramme: Baseline til 52 uker
Hypoglykemi er en tilstand som oppstår når en persons blodsukkernivå er lavere enn normalområdet (mindre enn eller lik 70 milligram per desiliter [mg/dL] eller mindre enn 3,9 millimol per liter [mmol/L]). Total hypoglykemi refererer til en hendelse som oppfyller kriteriene for dokumentert symptomatisk hypoglykemi, asymptomatisk hypoglykemi, sannsynlig symptomatisk hypoglykemi, uspesifisert hypoglykemi eller alvorlig hypoglykemi. Nattlig hypoglykemi refererer til enhver total hypoglykemisk hendelse som oppstår mellom leggetid og oppvåkning. Gruppegjennomsnitt (oppført som LS-midler nedenfor) forekomster av total og nattlig hypoglykemi ble beregnet ved bruk av en negativ binomial regresjonsmodell (antall episoder = behandling + SU/meglitinidbruk + baseline hypoglykemihendelsesrate, med log [eksponering per 30 dager] som offsetvariabel i modellen).
Baseline til 52 uker
Prosentandel av deltakere med hemoglobin A1c lik eller mindre enn 6,5 % og mindre enn 7,0 %
Tidsramme: 52 uker
Prosentandelen av deltakere ble beregnet ved å dele antall deltakere som nådde målet HbA1c med det totale antallet deltakere som ble analysert, multiplisert med 100.
52 uker
Fastende serumglukose (ved laboratoriemåling)
Tidsramme: 52 uker
LS-middelverdier ble beregnet ved bruk av en MMRM med baseline fastende serumglukosemåling, stratifiseringsfaktorer (land, HbA1c, LDL-C [< 100 mg/dL og ≥ 100 mg/dL], og bruk av SU/meglitinid), behandling, besøk og behandling-for-besøk interaksjon som faste effekter.
52 uker
Fastende blodsukker (av deltakerens egenkontrollerte blodsukkeravlesninger)
Tidsramme: 52 uker
LS-middelverdier ble beregnet ved bruk av en MMRM med fastende blodsukkermåling, stratifiseringsfaktorer (land, HbA1c, LDL-C [< 100 mg/dL og ≥ 100 mg/dL], og bruk av SU/meglitinid), behandling, besøk og behandling-for-besøk interaksjon som faste effekter.
52 uker
6-punkts selvovervåket blodsukker (SMBG)
Tidsramme: 52 uker
Sekspunkts SMBG-profiler ble oppnådd ved før-morgen-måltid (faste), før-middagsmåltid (lunsj), før-kveldsmåltid (middag), leggetid, ca. 0300 timer, og før-morgen-måltid (faste) neste dag. Seks-punkts SMBG-profiler ble oppnådd over 2 ikke-påfølgende dager i løpet av uken før neste kontorbesøk. LS-gjennomsnitt ble beregnet ved hjelp av en MMRM med baseline blodsukkermåling, stratifiseringsfaktorer (land, HbA1c, LDL-C [< 100 mg/dL og ≥ 100 mg/dL], og SU/meglitinid bruk), behandling, besøk og behandling -ved-besøk interaksjon som faste effekter.
52 uker
Endring fra baseline til 52 uker i kroppsvekt
Tidsramme: Utgangspunkt, 52 uker
LS-gjennomsnitt ble beregnet ved hjelp av en MMRM med baseline kroppsvektmåling, stratifiseringsfaktorer (land, HbA1c, LDL-C [< 100 mg/dL og ≥ 100 mg/dL], og SU/meglitinid bruk), behandling, besøk og behandling -ved-besøk interaksjon som faste effekter.
Utgangspunkt, 52 uker
Hemoglobin A1c
Tidsramme: 52 uker
HbA1c er en test som måler en persons gjennomsnittlige blodsukkernivå de siste 2 til 3 månedene. LS-gjennomsnitt ble beregnet ved bruk av en MMRM med baseline HbA1C-måling, stratifiseringsfaktorer (land, HbA1c, LDL-C [< 100 mg/dL og ≥ 100 mg/dL], og SU/meglitinid-bruk), behandling, besøk og behandling- ved-besøk interaksjon som faste effekter.
52 uker
Insulindose per kroppsvekt
Tidsramme: 52 uker
LS-gjennomsnitt ble beregnet ved bruk av en MMRM med baseline insulindosemåling, stratifiseringsfaktorer (land, HbA1c, LDL-C [< 100 mg/dL og ≥ 100 mg/dL], og SU/meglitinid bruk), behandling, besøk og behandling -ved-besøk interaksjon som faste effekter.
52 uker
Antall insulindosejusteringer til steady-state
Tidsramme: Baseline til 52 uker
Insulindoser ble justert i henhold til en algoritme (tilpasset fra Riddle et al. 2003) i løpet av de første 26 ukene av studien og deretter i henhold til etterforskerens vurdering. Steady-state ble definert som den første lokale maksimale dosen (maksimum ved bevegelig 4-ukers intervall) av LY2605541 eller glargin innen vinduet på +/- 2 uker. Antall dosejusteringer til steady-state var det totale antallet doseendringer inntil steady-state ble nådd. LS-gjennomsnitt ble beregnet ved bruk av en MMRM med baseline insulindosemåling, stratifiseringsfaktorer (land, HbA1c, LDL-C [< 100 mg/dL og ≥ 100 mg/dL], og SU/meglitinid bruk), behandling, besøk og behandling -ved-besøk interaksjon som faste effekter.
Baseline til 52 uker
European Quality of Life-5 Dimension (EQ-5D)
Tidsramme: 52 uker
EQ-5D er et generisk, flerdimensjonalt, helserelatert instrument for livskvalitet. Profilen lar deltakerne vurdere sin helsetilstand i 5 helsedomener (mobilitet, egenomsorg, vanlige aktiviteter, smerte/ubehag og angst/depresjon) ved å bruke en 3-nivå skala fra 1 til 3 (ingen problem, noen problemer, og ekstreme problemer). Disse kombinasjonene av attributter konverteres til en vektet helsetilstandsindeksscore i henhold til USAs befolkningsbaserte algoritme. Poeng varierer fra -0,11 til 1,0, hvor en poengsum på 1,0 indikerer perfekt helse. LS-middelverdier ble beregnet ved å bruke en MMRM med baseline-stratifiseringsfaktorer (land, HbA1c og SU/meglitinid-bruk), behandling, besøk og behandling-for-besøk interaksjon som faste effekter.
52 uker
Spørreskjema for tilfredshet med insulinbehandling
Tidsramme: Opptil 52 uker
Insulin Treatment Satisfaction Questionnaire (ITSQ) er et validert instrument som inneholder 22 elementer som vurderer behandlingstilfredshet for deltakere med diabetes som får insulin. Spørreskjemaet måler tilfredshet fra følgende 5 domener: ubeleilig med diett, livsstilsfleksibilitet, glykemisk kontroll, hypoglykemisk kontroll og insulintilførselsenhet. Data presentert er den transformerte totalskåren på en skala fra 0 til 100, der høyere skårer indikerer bedre behandlingstilfredshet. LS-middelverdier ble beregnet ved hjelp av en MMRM med stratifiseringsfaktorer (land, HbA1c og SU/meglitinid-bruk), behandling, besøk og behandling-for-besøk interaksjon som faste effekter.
Opptil 52 uker
Undersøkelse av lavt blodsukker for voksne
Tidsramme: Opptil 52 uker
Low Blood Sugar Survey for voksne (LBSS) er et validert, deltakerrapportert spørreskjema med 33 elementer med elementer vurdert på en 5-punkts Likert-skala, der 0 = aldri og 4 = alltid. LBSS måler atferd for å unngå hypoglykemi og dens negative konsekvenser (15 elementer) og bekymringer for hypoglykemi og dens negative konsekvenser (18 elementer). Total poengsum er summen av alle elementer (intervall fra 0 til 132). Høyere totalskår reflekterer større frykt for hypoglykemi. LS-middelverdier ble beregnet ved å bruke en analyse av kovariansmodell (ANCOVA) med baseline LBSS-score, stratifiseringsfaktorer (land, HbA1c og SU/meglitinid-bruk) og behandling som faste effekter.
Opptil 52 uker
Endring fra baseline til 52 uker i triglyserider, lavdensitetslipoproteinkolesterol (LDL-C) og høydensitetslipoproteinkolesterol (HDL-C)
Tidsramme: Utgangspunkt, 52 uker
LS-gjennomsnitt ble beregnet ved bruk av en MMRM med baseline lipidmåling, stratifiseringsfaktorer (land, HbA1c, LDL-C [< 100 mg/dL og ≥ 100 mg/dL], og SU/meglitinid bruk), behandling, besøk og behandling- interaksjon ved besøk som faste effekter.
Utgangspunkt, 52 uker
Prosentandel av deltakere med lik eller over 2- og 3 ganger øvre normalgrense (ULN) for total bilirubin
Tidsramme: Opptil 52 uker
Opptil 52 uker
Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)
Tidsramme: Baseline til 78 uker
Prosentandelen av deltakere med TEAR er oppsummert. TEAR er definert som en endring i anti-LY2605541-antistoffnivået fra ikke-detekterbart ved baseline til detekterbart ved baseline, eller, for de deltakerne med detekterbare antistoffer ved baseline, endring til en verdi med minst 130 % relativ økning fra baseline. Samlet TEAR er definert som en eller flere TEAR i løpet av den angitte perioden.
Baseline til 78 uker
Intra-deltaker variasjon av fastende blodsukker (FBG)
Tidsramme: 52 uker
Variabilitet mellom deltakere av FBG, som ble målt ved SMBG, ble vurdert ved standardavviket til FBG-målingen ved besøket i uke 52. LS-middelverdier ble beregnet ved bruk av en MMRM med fastende blodsukkermåling, stratifiseringsfaktorer (land, HbA1c, LDL-C [< 100 mg/dL og ≥ 100 mg/dL], og bruk av SU/meglitinid), behandling, besøk og behandling-for-besøk interaksjon som faste effekter.
52 uker
Prosentandel av deltakere med totale og nattlige hypoglykemiske hendelser
Tidsramme: Baseline til 52 uker
En hypoglykemisk hendelse er definert av en blodsukkerverdi ≤70 mg/dL (3,9 mmol/L). Totale hypoglykemiske hendelser inkluderer dokumentert symptomatisk hypoglykemi, asymptomatisk hypoglykemi, sannsynlig symptomatisk hypoglykemi, uspesifisert hypoglykemi eller alvorlig hypoglykemi. Nattlige hypoglykemiske hendelser refererer til enhver total hypoglykemisk hendelse som inntreffer mellom leggetid og oppvåkning. Prosentandelen av deltakere ble beregnet ved å dele antall deltakere med hypoglykemiske eller nattlige hypoglykemiske hendelser med det totale antallet deltakere som ble analysert, multiplisert med 100.
Baseline til 52 uker
Prosentandel av deltakere med HbA1C lik eller mindre enn 6,5 % og mindre enn 7,0 % og uten nattlig hypoglykemi
Tidsramme: Opptil 52 uker
Prosentandelen av deltakere med HbA1C ≤ 6,5 % eller < 7,0 % uten nattlig hypoglykemi er presentert. Prosentandelen ble beregnet ved å dele antall deltakere med de angitte HbA1c-verdiene over det totale antallet deltakere og multiplisere med 100.
Opptil 52 uker
Prosentandel av deltakere med lik eller over 2- og 3 ganger ULN for alanintransaminase/serumglutamisk pyruvic transaminase (ALT/SGPT) og aspartattransaminase/serumglutaminoksaloeddiksyretransaminase (AST/SGOT)
Tidsramme: Opptil 52 uker
Prosentandelen av deltakere ble beregnet ved å dele antall deltakere lik eller over 2- eller 3 ganger ULN for ALT/SGPT eller AST/SGOT med det totale antallet analyserte deltakere, multiplisert med 100.
Opptil 52 uker

Samarbeidspartnere og etterforskere

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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.

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

1. november 2011

Primær fullføring (Faktiske)

1. januar 2014

Studiet fullført (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først innsendt

9. september 2011

Først innsendt som oppfylte QC-kriteriene

15. september 2011

Først lagt ut (Anslag)

16. september 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mars 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

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. .

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