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G-PLUS (GALLANT, GALLEX and ARMOR - Post Treatment Follow-up Study)

14. mars 2008 oppdatert av: AstraZeneca

A Long-Term, Post-Treatment, Safety Follow-Up, Multi-Center Study in Patients With Type 2 Diabetes Mellitus From the GALLANT, GALLEX or ARMOR Studies.

This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24 months, in patients with type 2 diabetes after participation in the phaseII/III studies GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined laboratory or clinical findings, will have a 12-week post-treatment follow-up visit, including laboratory evaluation and adverse event recording.

Studieoversikt

Status

Avsluttet

Forhold

Studietype

Observasjonsmessig

Registrering

4500

Kontakter og plasseringer

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

Studiesteder

      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Córdoba, Argentina
        • Research Site
      • Rosario, Argentina
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      • Salta, Argentina
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    • Buenos Aires
      • Moron, Buenos Aires, Argentina
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      • Quilmes, Buenos Aires, Argentina
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      • Adelaide, Australia
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      • Geelong, Australia
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      • Tasmania, Australia
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      • Antwerpen, Belgia
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      • Hasselt, Belgia
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      • Liege, Belgia
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      • Merksem, Belgia
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      • Sint-Gillis-Waas, Belgia
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      • Steenokkerzeel, Belgia
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      • Curitiba, Brasil
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      • Fortaleza, Brasil
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      • Goiânia, Brasil
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      • Porto Alegre, Brasil
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      • Ribeirão Preto, Brasil
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      • São Paulo, Brasil
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    • Alberta
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    • Quebec
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      • Kauniainen, Finland
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      • Honolulu, Hawaii, Forente stater
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    • Indiana
      • Evansville, Indiana, Forente stater
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      • Indianapolis, Indiana, Forente stater
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    • Iowa
      • Waterloo, Iowa, Forente stater
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    • Kansas
      • Topeka, Kansas, Forente stater
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      • Wichita, Kansas, Forente stater
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    • Kentucky
      • Lexington, Kentucky, Forente stater
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    • Louisiana
      • Bossier City, Louisiana, Forente stater
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    • Maryland
      • Baltimore, Maryland, Forente stater
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    • Massachusetts
      • Haverhill, Massachusetts, Forente stater
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    • Michigan
      • Cadillac, Michigan, Forente stater
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      • Kalamazoo, Michigan, Forente stater
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    • Missouri
      • Excelsior Springs, Missouri, Forente stater
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      • Richmond Heights, Missouri, Forente stater
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      • Rolla, Missouri, Forente stater
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      • St Louis, Missouri, Forente stater
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    • Nebraska
      • Omaha, Nebraska, Forente stater
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    • Nevada
      • Las Vegas, Nevada, Forente stater
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      • North Las Vegas, Nevada, Forente stater
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      • Pahrump, Nevada, Forente stater
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      • Reno, Nevada, Forente stater
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    • New Hampshire
      • Dover, New Hampshire, Forente stater
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    • New Jersey
      • Hamilton, New Jersey, Forente stater
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      • Pleasantville, New Jersey, Forente stater
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    • New Mexico
      • Albuquerque, New Mexico, Forente stater
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    • New York
      • Bronx, New York, Forente stater
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      • Brooklyn, New York, Forente stater
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      • Flushing, New York, Forente stater
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      • New York, New York, Forente stater
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      • Olean, New York, Forente stater
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      • Rochester, New York, Forente stater
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      • Staten Island, New York, Forente stater
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      • White Plains, New York, Forente stater
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    • North Carolina
      • Asheville, North Carolina, Forente stater
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      • Charlotte, North Carolina, Forente stater
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      • Winston-Salem, North Carolina, Forente stater
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    • Ohio
      • Cincinnati, Ohio, Forente stater
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      • Cleveland, Ohio, Forente stater
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      • Dayton, Ohio, Forente stater
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      • Kettering, Ohio, Forente stater
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    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater
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    • Oregon
      • Medford, Oregon, Forente stater
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    • Pennsylvania
      • Altoona, Pennsylvania, Forente stater
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    • Utah
      • Salt Lake City, Utah, Forente stater
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    • Virginia
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    • Washington
      • Bellevue, Washington, Forente stater
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        • Research Site
      • Povazska Bystrica, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
      • Sahy, Slovakia
        • Research Site
      • Trencin, Slovakia
        • Research Site
      • Trnava, Slovakia
        • Research Site
      • Velky Meder, Slovakia
        • Research Site
      • Zilina, Slovakia
        • Research Site
      • Barcelona, Spania
        • Research Site
      • Begonte (Lugo), Spania
        • Research Site
      • Guissona (Lleida), Spania
        • Research Site
      • Madrid, Spania
        • Research Site
      • San Sebastian de los Reyes, Spania
        • Research Site
      • San Vicente de Raspeig (Alicante), Spania
        • Research Site
      • Sevilla, Spania
        • Research Site
      • Valencia, Spania
        • Research Site
      • Villar del Arzobispo (Valencia), Spania
        • Research Site
      • Aberdeen, Storbritannia
        • Research Site
      • Atherstone, Storbritannia
        • Research Site
      • Ayr, Storbritannia
        • Research Site
      • Bath, Storbritannia
        • Research Site
      • Belfast, Storbritannia
        • Research Site
      • Berks, Storbritannia
        • Research Site
      • Birmingham, Storbritannia
        • Research Site
      • Bolton, Storbritannia
        • Research Site
      • Bucks, Storbritannia
        • Research Site
      • Cardiff, Storbritannia
        • Research Site
      • Co Antrim N Ireland, Storbritannia
        • Research Site
      • Co. Wexford, Ireland, Storbritannia
        • Research Site
      • Coventry, Storbritannia
        • Research Site
      • Dublin, Storbritannia
        • Research Site
      • Dundee, Storbritannia
        • Research Site
      • Edinburgh, Storbritannia
        • Research Site
      • Glasgow, Storbritannia
        • Research Site
      • Kent, Storbritannia
        • Research Site
      • Leeds, Storbritannia
        • Research Site
      • Liverpool, Storbritannia
        • Research Site
      • Manchester, Storbritannia
        • Research Site
      • Northampton, Storbritannia
        • Research Site
      • Pembrokeshire, Storbritannia
        • Research Site
      • Plymouth, Storbritannia
        • Research Site
      • Radstock, Storbritannia
        • Research Site
      • Reading, Storbritannia
        • Research Site
      • Shrewsbury, Storbritannia
        • Research Site
      • Surrey, Storbritannia
        • Research Site
      • West Midlands, Storbritannia
        • Research Site
      • Wiltshire, Storbritannia
        • Research Site
      • Wrexham, Storbritannia
        • Research Site
      • Bern, Sveits
        • Research Site
      • Ilanz, Sveits
        • Research Site
      • Lausanne, Sveits
        • Research Site
      • Monthey, Sveits
        • Research Site
      • Zürich, Sveits
        • Research Site
      • Borås, Sverige
        • Research Site
      • Dalby, Sverige
        • Research Site
      • Göteborg, Sverige
        • Research Site
      • Höganäs, Sverige
        • Research Site
      • Malmö, Sverige
        • Research Site
      • Mölndal, Sverige
        • Research Site
      • Partille, Sverige
        • Research Site
      • Skene, Sverige
        • Research Site
      • Skrivarp, Sverige
        • Research Site
      • Stenungsund, Sverige
        • Research Site
      • Uddevalla, Sverige
        • Research Site
      • Uppsala, Sverige
        • Research Site
      • Vänersborg, Sverige
        • Research Site
      • Åmål, Sverige
        • Research Site
      • Cape Town, Sør-Afrika
        • Research Site
      • Chatsworth, Sør-Afrika
        • Research Site
      • Durban, Sør-Afrika
        • Research Site
      • Gauteng, Sør-Afrika
        • Research Site
      • Houghton Gauteng, Sør-Afrika
        • Research Site
      • Johannesburg, Sør-Afrika
        • Research Site
      • Pretoria, Sør-Afrika
        • Research Site
      • Changhua, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Bangkok, Thailand
        • Research Site
      • Belgrade, Tidligere Serbia og Montenegro
        • Research Site
      • Brno, Tsjekkisk Republikk
        • Research Site
      • Hodonin, Tsjekkisk Republikk
        • Research Site
      • Hradec Kralove, Tsjekkisk Republikk
        • Research Site
      • Plzen, Tsjekkisk Republikk
        • Research Site
      • Praha, Tsjekkisk Republikk
        • Research Site
      • Pribram, Tsjekkisk Republikk
        • Research Site
      • Semily, Tsjekkisk Republikk
        • Research Site
      • Tabor, Tsjekkisk Republikk
        • Research Site
      • Usti nad Labem, Tsjekkisk Republikk
        • Research Site
      • Aschaffenburg, Tyskland
        • Research Site
      • Beckum, Tyskland
        • Research Site
      • Berlin, Tyskland
        • Research Site
      • Dresden, Tyskland
        • Research Site
      • Duesseldorf, Tyskland
        • Research Site
      • Ehrenberg, Tyskland
        • Research Site
      • Essen, Tyskland
        • Research Site
      • Gelnhausen, Tyskland
        • Research Site
      • Hamburg, Tyskland
        • Research Site
      • Hannover, Tyskland
        • Research Site
      • Heidelberg, Tyskland
        • Research Site
      • Heilbronn, Tyskland
        • Research Site
      • Hermaringen, Tyskland
        • Research Site
      • Künzing, Tyskland
        • Research Site
      • Langen, Tyskland
        • Research Site
      • Mannheim, Tyskland
        • Research Site
      • Marl, Tyskland
        • Research Site
      • Nürberg, Tyskland
        • Research Site
      • Pirna, Tyskland
        • Research Site
      • Rotenburg/Fulda, Tyskland
        • Research Site
      • Balatonfüred, Ungarn
        • Research Site
      • Budapest, Ungarn
        • Research Site
      • Gy?r, Ungarn
        • Research Site
      • Kaposvár, Ungarn
        • Research Site
      • Kecskemét, Ungarn
        • Research Site
      • Miskolc, Ungarn
        • Research Site
      • Siófok, Ungarn
        • Research Site
      • Székesfehérvár, Ungarn
        • Research Site
      • Hanoi, Vietnam
        • Research Site
      • Ho Chi Minh, Vietnam
        • Research Site

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

Inclusion Criteria:

  • Provision of a written informed consent
  • Men or women who either completed at least 6 months in a previous treatment study GALLANT, GALLEX or ARMOR or met a pre-defined laboratory or clinical finding during participation in any of the said studies.

Exclusion Criteria:

  • Received open-label treatment with tesaglitazar (since this is a post-treatment study)

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Samarbeidspartnere og etterforskere

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

Sponsor

Etterforskere

  • Studieleder: AstrasZeneca Galida Medical Science Director, MD, AstraZeneca

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. september 2005

Studiet fullført (Faktiske)

1. desember 2006

Datoer for studieregistrering

Først innsendt

18. november 2005

Først innsendt som oppfylte QC-kriteriene

18. november 2005

Først lagt ut (Anslag)

21. november 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. mars 2008

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mars 2008

Sist bekreftet

1. mars 2008

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • D6160C00056
  • EudraCT No 2005-001373-97

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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