- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00355849
Evaluer effektiviteten og sikkerheten til insulin hos pasienter med type 2-diabetes
6. september 2019 oppdatert av: Eli Lilly and Company
En fase 3, åpen, tre-gruppe parallel studie for å evaluere effektiviteten og sikkerheten til humant insulin inhalasjonspulver (HIIP) hos pasienter med type 2 diabetes behandlet med insulin Glargine én gang daglig.
En studie for å evaluere effektiviteten og sikkerheten til humant insulin inhalasjonspulver [også kjent som AIR® inhalert insulin][AIR® er et registrert varemerke for Alkermes, Inc.] hos pasienter med type 2 diabetes som for tiden behandles med insulin én gang daglig glargininjeksjoner.
Den nåværende studien er ment å avgjøre om AIR® insulin ved måltid kan være bedre enn injeksjoner av insulin glargin én gang daglig.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
555
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Curitiba, Brasil, 80060-900
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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São Paulo, Brasil, 04020041
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Alberta
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Red Deer, Alberta, Canada, T4N 6V7
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
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Ontario
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Cambridge, Ontario, Canada, N2R 7L6
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Thornhill, Ontario, Canada, L4J 8L7
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Quebec
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Sainte-Foy, Quebec, Canada, G1V 4G2
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Moscow, Den russiske føderasjonen, 125315
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Saint Petersburg, Den russiske føderasjonen, 195176
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California
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Fresno, California, Forente stater, 93720
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Pomona, California, Forente stater, 91767
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Florida
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West Palm Beach, Florida, Forente stater, 33401
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Georgia
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Atlanta, Georgia, Forente stater, 30309
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Illinois
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Peoria, Illinois, Forente stater, 61615
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Indiana
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New Albany, Indiana, Forente stater, 47150
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Kansas
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Topeka, Kansas, Forente stater, 66606
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Louisiana
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Metairie, Louisiana, Forente stater, 70006
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Michigan
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Ann Arbor, Michigan, Forente stater, 48108
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Grand Rapids, Michigan, Forente stater, 49503
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Nebraska
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Omaha, Nebraska, Forente stater, 68131
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New Hampshire
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Nashua, New Hampshire, Forente stater, 03063
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New Jersey
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Cherry Hill, New Jersey, Forente stater, 08002
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Flemington, New Jersey, Forente stater, 08822
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
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Texas
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Austin, Texas, Forente stater, 78731
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Dallas, Texas, Forente stater, 75230
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Georgetown, Texas, Forente stater, 78626
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New Braunfels, Texas, Forente stater, 78130
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Antonio, Texas, Forente stater, 78229
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Utah
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Midvale, Utah, Forente stater, 84047
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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.
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Salt Lake City, Utah, Forente stater, 84107
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Olympia, Washington, Forente stater, 98506
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bangalore, India, 560038
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Chennai, India, 600 010
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Indore, India, 452 003
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Ludhiana, India, 141001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Holon, Israel, 22100
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Nahariya, Israel, 22100
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Tel-Hashomer, Israel, 52621
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Seoul, Korea, Republikken, 137-701
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Suwon-City, Korea, Republikken, 442-721
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Carolina, Puerto Rico, 00983
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Manatí, Puerto Rico, 00674
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San Juan, Puerto Rico, 00907
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Toa Baja, Puerto Rico, 00950
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Alicante, Spania, 03114
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Alzira, Spania, 46220
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Barcelona, Spania, 08017
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Dos Hermanas, Spania, 41014
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La Coruña, Spania, 15006
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Madrid, Spania, 28006
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Palma De Mallorca, Spania, 07198
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Manchester, Storbritannia, M41 5SL
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Cleveland
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Middlesbrough, Cleveland, Storbritannia, TS4 3BW
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East Lancashire
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Blackburn, East Lancashire, Storbritannia, BB2 3HH
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Glamorgan
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Penarth, South Glamorgan, Storbritannia, CF64 2XX
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wales
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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.
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West Lothian
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Livingston, West Lothian, Storbritannia, EH54 6PP
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West Midlands
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Birmingham, West Midlands, Storbritannia, B9 5SS
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Pretoria, Sør-Afrika, 0083
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Aschaffenburg, Tyskland, 63739
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Berlin, Tyskland, 10115
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Dresden, Tyskland, 01307
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Hamburg, Tyskland, 22607
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Mainz, Tyskland, D-55116
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Münster, Tyskland, 48145
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Rodgau, Tyskland, D-63110
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Witten, Tyskland, 58455
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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:
- type 2 diabetes mellitus
- ett eller flere orale antihyperglykemiske medisiner
- insulin glargin én gang daglig
- HbA1c større enn eller lik 7,5 og mindre enn eller lik 10,5 %
- Ikke-røyker
Ekskluderingskriterier:
- tar en TZD-dose større enn det som er indikert
- mer enn to episoder med alvorlig hypoglykemi i løpet av 6 måneder før
- Har hatt en nedre luftveisinfeksjon de 3 månedene før
- systemisk glukokortikoidbehandling
- kliniske tegn eller symptomer på leversykdom, akutt eller kronisk hepatitt
- historie med nyretransplantasjon
- Har en aktiv eller ubehandlet malignitet
- Krever mer enn 150 U/dag insulin glargin
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
Intensifisert Glargine
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pasientspesifikk dose, injiserbar, før måltider, 52 uker
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Eksperimentell: 2
HIIP
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pasientspesifikk dose, inhalert, før måltider, 52 uker
Andre navn:
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Eksperimentell: 3
Intensified Glargine pluss HIIP
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pasientspesifikk dose, injiserbar, før måltider, 52 uker
pasientspesifikk dose, inhalert, før måltider, 52 uker
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
For å sammenligne hos pasienter som ved studiestart har type 2-diabetes som ikke er optimalt kontrollert av en eller flere orale antihyperglykemiske medisiner pluss insulin glargin én gang daglig, et regime som kan inkludere måltider med AIR Insulin.
Tidsramme: 24 uker
|
24 uker
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
For å måle endringer i HbA1c over tid
Tidsramme: 24 uker
|
24 uker
|
For å vurdere insulindosebehov
Tidsramme: 24 og 52 uker
|
24 og 52 uker
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For å vurdere rate og forekomst av hypoglykemi
Tidsramme: 24 og 52 uker
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24 og 52 uker
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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.
Hjelpsomme linker
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. august 2006
Primær fullføring (Faktiske)
1. juni 2008
Studiet fullført (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først innsendt
21. juli 2006
Først innsendt som oppfylte QC-kriteriene
21. juli 2006
Først lagt ut (Anslag)
25. juli 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 9632
- H7U-MC-IDBA (Annen identifikator: Eli Lilly and Company)
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
- Studieprotokoll
- Statistisk analyseplan (SAP)
- Klinisk studierapport (CSR)
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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