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Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus

19. februar 2015 opdateret af: AstraZeneca

A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus

This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

156

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35209
        • Innovative Clinical Trials
      • Birmingham, Alabama, Forenede Stater, 35243
        • Healthsouth Clinical Research
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Endocrinology Clinic of O.C.
      • Bellflower, California, Forenede Stater, 90706
        • Pioneer Medical Group
      • Chula Vista, California, Forenede Stater, 91910
        • International Clinical Research Network
      • Fresno, California, Forenede Stater, 93721
        • Bautista Research and Medical Clinic
      • La Jolla, California, Forenede Stater, 92037
        • Whittier Institute for Diabetes
      • Los Gatos, California, Forenede Stater, 95032
        • Richard Cherlin, M.D.
      • Moreno Valley, California, Forenede Stater, 92553
        • Dr. Martinez Medical Clinic
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80010
        • Anshutz Outpatient Pavilion
    • Florida
      • Clearwater, Florida, Forenede Stater, 33760
        • Diagnostic Clinic
      • Gainsville, Florida, Forenede Stater, 32605
        • Radiant Research-Gainsville
      • Jacksonville, Florida, Forenede Stater, 32216
        • Jacksonville Center for Clinical Research
      • Pinellas Park, Florida, Forenede Stater, 33781
        • Radiant Research-Pinellas Park
    • Georgia
      • Blairsville, Georgia, Forenede Stater, 30512
        • Clinical Research Group of North Georgia
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • East-West Medical Research Institute
      • Honolulu, Hawaii, Forenede Stater, 96814
        • Radiant Research-Honolulu
    • Idaho
      • Boise, Idaho, Forenede Stater, 83704
        • Radiant Research-Boise
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60607
        • Cedar-Crosse Research Center
    • Louisiana
      • Covington, Louisiana, Forenede Stater, 70433
        • Northshore Medical Research, LLC
      • Slidell, Louisiana, Forenede Stater, 70458
        • Medical Research Institute
    • Massachusetts
      • Concord, Massachusetts, Forenede Stater, 01742
        • Melvin Kramer, MD
    • Minnesota
      • Edina, Minnesota, Forenede Stater, 55435
        • Radiant Research-Edina
    • Mississippi
      • Gulfport, Mississippi, Forenede Stater, 39501
        • Mississippi Medical Research, LLC
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64114
        • The Center for Pharmaceutical Research
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Innovative Health Research
    • North Carolina
      • Cary, North Carolina, Forenede Stater, 27511
        • Carolina Advanced Research
    • Ohio
      • Maumee, Ohio, Forenede Stater, 43537
        • Fallen Timbers Internal Medicine, LLC
    • Texas
      • Benbrook, Texas, Forenede Stater, 76126
        • Millenium Research
      • Desoto, Texas, Forenede Stater, 75115
        • Healthsouth Clinical Research
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine/Clinical Studies Unit
      • Midland, Texas, Forenede Stater, 79705
        • Diabetes Center of the Southwest
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84108
        • Utah Diabetes Center at the University of Utah

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects with type 2 diabetes
  • Treated with diet and exercise alone or with metformin for at least 3 months prior to screening
  • BMI 27-45 kg/m^2
  • HbA1c between 7.0 % and 8.0 %

Exclusion Criteria:

  • Treated with other oral anti-diabetic agents other than metformin within 3 months of screening
  • Patients previously treated with AC2993
  • Patients presently treated with insulin

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo 0.01 mL
2 week placebo lead-in followed by Placebo 0.01 mL
Medicin: Placebo 0.01 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
Placebo komparator: Placebo 0.02 mL
2 week placebo lead-in followed by Placebo 0.02 mL
Medicin: Placebo 0.02 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
Placebo komparator: Placebo 0.03 mL
2 week placebo lead-in followed by Placebo 0.03 mL
Medicin: Placebo 0.03 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
Placebo komparator: Placebo 0.04 mL
2 week placebo lead-in followed by Placebo 0.04 mL
Medicin: Placebo 0.04 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
Eksperimentel: AC2993 2.5 mcg
2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL
Medicin: AC2993 2.5 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily
Andre navne:
  • syntetisk exendin-4
Eksperimentel: AC2993 5.0 mcg
2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL
Medicin: AC2993 5.0 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily
Andre navne:
  • syntetisk exendin-4
Eksperimentel: AC2993 7.5 mcg
2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL
Medicin: AC2993 7.5 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily
Andre navne:
  • syntetisk exendin-4
Eksperimentel: AC2993 10.0 mcg
2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL
Medicin: AC2993 10.0 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily
Andre navne:
  • syntetisk exendin-4

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
Tidsramme: Baseline (Day 1) to Day 28
Change in HbA1c from Baseline (Day 1) to study termination (Day 28)
Baseline (Day 1) to Day 28

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in HbA1c from Baseline to Day 14
Tidsramme: Baseline, Day 14
Change in HbA1c from Baseline (Day 1) to Day 14
Baseline, Day 14
Change in fasting plasma glucose from Baseline to Day 14 and to Day 28
Tidsramme: Baseline, Day 14, Day28
Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28)
Baseline, Day 14, Day28
Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28
Tidsramme: Baseline, Day 14, Day 28
Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Baseline, Day 14, Day 28

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

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.

Generelle publikationer

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. august 2002

Primær færdiggørelse (Faktiske)

1. maj 2003

Studieafslutning (Faktiske)

1. maj 2003

Datoer for studieregistrering

Først indsendt

3. september 2002

Først indsendt, der opfyldte QC-kriterier

4. september 2002

Først opslået (Skøn)

5. september 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. februar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2015

Sidst verificeret

1. januar 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2993-116

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, ikke-insulinafhængig

Kliniske forsøg med Placebo 0.01 mL

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Betingelser

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