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Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose

28. oktober 2008 opdateret af: Pfizer

A One-Year, Open, Randomized, Parallel, Three-Arm Study Comparing Exubera® (Insulin Dry Powder Pulmonary Inhaler) vs. Avandia® (Rosiglitazone Maleate) as Add-On Therapy vs. Exubera® Substitution of Sulfonylurea in Patients With Type 2 Diabetes, Poorly Controlled on Combination Sulfonylurea and Metformin Treatment

  • Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug.
  • Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

626

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Pfizer Investigational Site
      • Wollongong, New South Wales, Australien, 2500
        • Pfizer Investigational Site
    • Queensland
      • Herston, Queensland, Australien, 4029
        • Pfizer Investigational Site
      • Woolloongabba, Queensland, Australien, 4102
        • Pfizer Investigational Site
    • South Australia
      • Keswick, South Australia, Australien, 5035
        • Pfizer Investigational Site
    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • Pfizer Investigational Site
      • Caulfield, Victoria, Australien, 3162
        • Pfizer Investigational Site
  • Brasilien
    • RS
      • Porto Alegre, RS, Brasilien, 90035-170
        • Pfizer Investigational Site
    • SP
      • Sao Paulo, SP, Brasilien, 01244-030
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brasilien, 04231-030
        • Pfizer Investigational Site
  • Canada
      • St. John's, Canada, A1E 2E2
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Pfizer Investigational Site
      • Mississauga, Ontario, Canada, L5M2V8
        • Pfizer Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Pfizer Investigational Site
      • Thornhill, Ontario, Canada, L4J 1V8
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4N-3M5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4R 2G4
        • Pfizer Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Pfizer Investigational Site
      • St Jerome, Quebec, Canada, J7Z 5T3
        • Pfizer Investigational Site
      • Vaudreuil, Quebec, Canada, J7V 8P9
        • Pfizer Investigational Site
  • Forenede Stater
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85205
        • Pfizer Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85012
        • Pfizer Investigational Site
      • Tucson, Arizona, Forenede Stater, 85715
        • Pfizer Investigational Site
    • Arkansas
      • Searcy, Arkansas, Forenede Stater, 72143
        • Pfizer Investigational Site
    • California
      • Alhambra, California, Forenede Stater, 91801
        • Pfizer Investigational Site
      • Concord, California, Forenede Stater, 94520
        • Pfizer Investigational Site
      • Huntington Beach, California, Forenede Stater, 92648
        • Pfizer Investigational Site
      • Huntington Beach, California, Forenede Stater, 92647
        • Pfizer Investigational Site
      • La Jolla, California, Forenede Stater, 92037
        • Pfizer Investigational Site
      • Long Beach, California, Forenede Stater, 90806
        • Pfizer Investigational Site
      • Long Beach, California, Forenede Stater, 90805
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90048
        • Pfizer Investigational Site
      • Riverside, California, Forenede Stater, 92506
        • Pfizer Investigational Site
      • Santa Barbara, California, Forenede Stater, 93105
        • Pfizer Investigational Site
      • Tustin, California, Forenede Stater, 92780
        • Pfizer Investigational Site
      • Westminster, California, Forenede Stater, 92683
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, Forenede Stater, 80209
        • Pfizer Investigational Site
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, Forenede Stater, 06708
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Pfizer Investigational Site
      • Washington, District of Columbia, Forenede Stater, 20307
        • Pfizer Investigational Site
    • Florida
      • Hollywood, Florida, Forenede Stater, 33021
        • Pfizer Investigational Site
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Pfizer Investigational Site
      • Winter Park, Florida, Forenede Stater, 32789
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Pfizer Investigational Site
      • Augusta, Georgia, Forenede Stater, 30909
        • Pfizer Investigational Site
      • Savannah, Georgia, Forenede Stater, 31405
        • Pfizer Investigational Site
      • Savannah, Georgia, Forenede Stater, 31419
        • Pfizer Investigational Site
    • Hawaii
      • Ewa Beach, Hawaii, Forenede Stater, 96706
        • Pfizer Investigational Site
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Pfizer Investigational Site
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404-6370
        • Pfizer Investigational Site
      • Idaho Falls, Idaho, Forenede Stater, 83404-7542
        • Pfizer Investigational Site
      • Idaho Falls,, Idaho, Forenede Stater, 83404-7542
        • Pfizer Investigational Site
    • Illinois
      • Chicago Heights, Illinois, Forenede Stater, 60411
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Pfizer Investigational Site
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50314
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67203
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503
        • Pfizer Investigational Site
      • Louisville, Kentucky, Forenede Stater, 40213
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Pfizer Investigational Site
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21204
        • Pfizer Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01103
        • Pfizer Investigational Site
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Pfizer Investigational Site
      • Waltham, Massachusetts, Forenede Stater, 02453
        • Pfizer Investigational Site
    • Minnesota
      • West St. Paul, Minnesota, Forenede Stater, 55118
        • Pfizer Investigational Site
    • Missouri
      • North Kansas City, Missouri, Forenede Stater, 64116
        • Pfizer Investigational Site
      • St. Louis, Missouri, Forenede Stater, 63141
        • Pfizer Investigational Site
    • Montana
      • Butte, Montana, Forenede Stater, 59701
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68521
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Pfizer Investigational Site
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • Pfizer Investigational Site
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Pfizer Investigational Site
      • Flushing, New York, Forenede Stater, 11365
        • Pfizer Investigational Site
      • Mineola, New York, Forenede Stater, 11501
        • Pfizer Investigational Site
      • New Hyde Park, New York, Forenede Stater, 11042
        • Pfizer Investigational Site
      • Rochester, New York, Forenede Stater, 14642
        • Pfizer Investigational Site
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Pfizer Investigational Site
      • Cleveland, Ohio, Forenede Stater, 44195
        • Pfizer Investigational Site
      • Lakewood, Ohio, Forenede Stater, 44107
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Pfizer Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15235
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Pfizer Investigational Site
      • Charleston, South Carolina, Forenede Stater, 29401-5799
        • Pfizer Investigational Site
      • Duncan, South Carolina, Forenede Stater, 29334
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, Forenede Stater, 29307
        • Pfizer Investigational Site
      • Sumter, South Carolina, Forenede Stater, 29150
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Pfizer Investigational Site
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Pfizer Investigational Site
      • Memphis, Tennessee, Forenede Stater, 38119
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37232
        • Pfizer Investigational Site
    • Texas
      • Corpus Christi, Texas, Forenede Stater, 78411
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75246
        • Pfizer Investigational Site
      • El Paso, Texas, Forenede Stater, 79935
        • Pfizer Investigational Site
      • El Paso, Texas, Forenede Stater, 79925
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78237
        • Pfizer Investigational Site
    • Utah
      • Ogden, Utah, Forenede Stater, 84403
        • Pfizer Investigational Site
    • Virginia
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Pfizer Investigational Site
      • Richmond, Virginia, Forenede Stater, 23294
        • Pfizer Investigational Site
      • Richmond, Virginia, Forenede Stater, 23221
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, Forenede Stater, 98055
        • Pfizer Investigational Site
      • Tukwila, Washington, Forenede Stater, 98188
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Pfizer Investigational Site
  • Mexico
      • Mexico Df, Mexico, CP 14000
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 02990
        • Pfizer Investigational Site
      • Mexico, DF, Mexico, 03100
        • Pfizer Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Pfizer Investigational Site
      • Guadalajara, Jalisco, Mexico, 44349
        • Pfizer Investigational Site
      • Guadalajara, Jalisco, Mexico, 44660
        • Pfizer Investigational Site
    • Jalisco/Mexico
      • Guadalajara, Jalisco/Mexico, Mexico, 44347
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64060
        • Pfizer Investigational Site
    • Veracruz
      • Jalapa, Veracruz, Mexico, 91020
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Type 2 diabetes
  • Currently treated and on a stable doses of drugs for the preceding two (2) months

Exclusion Criteria:

  • Type 1 Diabetes
  • Smoking

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Glycosylated hemoglobin

Sekundære resultatmål

Resultatmål
Change from baseline in fasting plasma glucose. Other secondary efficacy
endpoints include, body weight, patient reported outcomes, incidence and severity
of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to
insufficient clinical response.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Samarbejdspartnere

Sanofi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2003

Studieafslutning (Faktiske)

1. juni 2007

Datoer for studieregistrering

Først indsendt

6. september 2005

Først indsendt, der opfyldte QC-kriterier

6. september 2005

Først opslået (Skøn)

8. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. oktober 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. oktober 2008

Sidst verificeret

1. oktober 2008

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A2171017

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus

Kliniske forsøg med Inhaled insulin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Germany

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner