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Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.

9. februar 2007 opdateret af: Pfizer

Efficacy And Safety Of Exubera (Inhaled Insulin) Therapy In Subjects With Type 2 Diabetes Mellitus Not Well Controlled With Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial.

To assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

345

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 0M3
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T6G 2C8
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T6G 2S2
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T5H 3V9
        • Pfizer Investigational Site
      • Red Deer, Alberta, Canada, T4N 6V7
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Pfizer Investigational Site
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Pfizer Investigational Site
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Pfizer Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5G 1X5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5B 1WB
        • Pfizer Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Pfizer Investigational Site
  • Forenede Stater
    • California
      • Irvine, California, Forenede Stater, 92618
        • Pfizer Investigational Site
      • Long Beach, California, Forenede Stater, 90806
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90073
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90059
        • Pfizer Investigational Site
      • Newport Beach, California, Forenede Stater, 92663
        • Pfizer Investigational Site
      • San Diego, California, Forenede Stater, 92108
        • Pfizer Investigational Site
      • Tustin, California, Forenede Stater, 92780
        • Pfizer Investigational Site
    • Connecticut
      • New Britain, Connecticut, Forenede Stater, 06050
        • Pfizer Investigational Site
      • New Haven, Connecticut, Forenede Stater, 06519
        • Pfizer Investigational Site
      • New Haven, Connecticut, Forenede Stater, 06510
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, Forenede Stater, 33761
        • Pfizer Investigational Site
      • Hollywood, Florida, Forenede Stater, 33021
        • Pfizer Investigational Site
      • Miami, Florida, Forenede Stater, 33136
        • Pfizer Investigational Site
      • Tampa, Florida, Forenede Stater, 33607
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55416
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65212
        • Pfizer Investigational Site
      • St. Louis, Missouri, Forenede Stater, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68131
        • Pfizer Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10025
        • Pfizer Investigational Site
      • New York, New York, Forenede Stater, 10016
        • Pfizer Investigational Site
      • Rochester, New York, Forenede Stater, 14642
        • Pfizer Investigational Site
    • North Carolina
      • Greenville, North Carolina, Forenede Stater, 27858
        • Pfizer Investigational Site
      • Winston-salem, North Carolina, Forenede Stater, 27157
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97201-3098
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater, 78758
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75246
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75235-8858
        • Pfizer Investigational Site
      • Irving, Texas, Forenede Stater, 75061
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, Forenede Stater, 98055
        • 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

35 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 Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier.
  • Patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin).

Exclusion Criteria:

  • Asthma, COPD
  • Smoking during the previous 6 months

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
The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.
HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values.

Sekundære resultatmål

Resultatmål
Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies)
Meal glucose response measured at Week -1 and at Week 12;
These results for efficacy are measured in the lab using plasma samples collected during clinic visits,
not the subject's home glucose monitoring results.
Comparison of 24-hour home glucose profiles.
Proportion of subjects with acceptable or good glycemic control (e.g., HbA1c < 8.0% or <7.0%) at the end of treatment, incidence and severity of hypoglycemic episodes, discontinuation rate, change in fasting lipid profile, and change in body weight.
A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

Samarbejdspartnere

Sanofi
Nektar Therapeutics

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. juni 1999

Studieafslutning

1. september 2000

Datoer for studieregistrering

Først indsendt

29. august 2006

Først indsendt, der opfyldte QC-kriterier

29. august 2006

Først opslået (Skøn)

31. august 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. februar 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. februar 2007

Sidst verificeret

1. februar 2007

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 217-109

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, type 2

Kliniske forsøg med Inhaleret human insulin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Armenia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner