- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00065312
An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
18. juli 2006 oppdatert av: Eli Lilly and Company
The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Fase
- Fase 2
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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Alabama
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Birmingham, Alabama, Forente stater
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Huntsville, Alabama, Forente stater
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Arizona
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Peoria, Arizona, Forente stater
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Tucson, Arizona, Forente stater
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Arkansas
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Little Rock, Arkansas, Forente stater
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California
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Bakersfield, California, Forente stater
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Pico Rivera, California, Forente stater
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San Diego, California, Forente stater
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Santa Ana, California, Forente stater
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Colorado
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Denver, Colorado, Forente stater
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Connecticut
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Waterbury, Connecticut, Forente stater
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West Hartford, Connecticut, Forente stater
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Florida
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Clearwater, Florida, Forente stater
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Kissimmee, Florida, Forente stater
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Ocala, Florida, Forente stater
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St Petersburg, Florida, Forente stater
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Georgia
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Decatur, Georgia, Forente stater
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Hawaii
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Honolulu, Hawaii, Forente stater
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Illinois
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Orland Park, Illinois, Forente stater
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Peoria, Illinois, Forente stater
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Indiana
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Evansville, Indiana, Forente stater
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Kansas
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Wichita, Kansas, Forente stater
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Kentucky
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Louisville, Kentucky, Forente stater
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Maryland
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Baltimore, Maryland, Forente stater
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Minnesota
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Edina, Minnesota, Forente stater
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Minneapolis, Minnesota, Forente stater
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New York
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Endwell, New York, Forente stater
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Great Neck, New York, Forente stater
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North Carolina
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Charlotte, North Carolina, Forente stater
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Fayetteville, North Carolina, Forente stater
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater
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Oregon
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Eugene, Oregon, Forente stater
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Pennsylvania
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Allentown, Pennsylvania, Forente stater
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Fleetwood, Pennsylvania, Forente stater
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Lansdale, Pennsylvania, Forente stater
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Philadelphia, Pennsylvania, Forente stater
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South Carolina
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MT Pleasant, South Carolina, Forente stater
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Texas
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San Antonio, Texas, Forente stater
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Utah
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Salt Lake City, Utah, Forente stater
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Virginia
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Lebanon, Virginia, Forente stater
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Washington
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Renton, Washington, Forente stater
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Spokane, Washington, Forente stater
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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 til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosis of Type 2 Diabetes for at least 3 months.
- Diabetes managed with diet and exercise alone or with either metformin or sulfonylurea alone as an adjunct to diet and exercise.
- Diabetes therapy must be unchanged for at least 3 months prior to screening.
- Females must be of non-childbearing potential (surgically sterilized or at least 1 year post-menopausal, as defined by cessation of menses). Female patients who are not surgically sterilized and who are less than or equal to 45 years should have their post-menopausal status confirmed by FSH greater that 30ng/mL at screening.
Exclusion Criteria:
- Current use of insulin or any antidiabetic agent other than a sulfonylurea agent or metformin.
- Current use of metformin or a sulfonylurea agent in combination.
- History of liver disease.
- History of unstable angina (as defined by the Braunwald system), myocardial infarction, or a coronary revascularization procedure within the past 6 months.
- Currently suspected carcinoma or history of carcinoma in the last 5 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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.
Datoer for studieregistrering
Først innsendt
21. juli 2003
Først innsendt som oppfylte QC-kriteriene
21. juli 2003
Først lagt ut (Anslag)
22. juli 2003
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. juli 2006
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juli 2006
Sist bekreftet
1. juli 2006
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5837
- H7R-MC-GCBD
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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