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Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

8. april 2015 opdateret af: AstraZeneca

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

365

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Den Russiske Føderation
      • Moscov, Den Russiske Føderation, 118089
        • Local Institution
      • Moscow, Den Russiske Føderation, 115487
        • Local Institution
      • Nizhniy Novgorod, Den Russiske Føderation, 603126
        • Local Institution
      • Saint Petersburg, Den Russiske Føderation, 198013
        • Local Institution
      • Saratov, Den Russiske Føderation, 410018
        • Local Institution
      • Saratov, Den Russiske Føderation, 410054
        • Local Institution
      • Smolensk, Den Russiske Føderation, 214018
        • Local Institution
      • St.Petersburg, Den Russiske Føderation, 194156
        • Local Institution
      • Volgograd, Den Russiske Føderation, 400138
        • Local Institution
  • Forenede Stater
    • Alabama
      • Columbiana, Alabama, Forenede Stater, 35051
        • Tomac, Inc.
      • Haleyville, Alabama, Forenede Stater, 35565
        • Winston Technology, Inc.
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85213
        • Clinical Reseacrh Advantage/ Brown Family Medicine
    • California
      • Bakersfield, California, Forenede Stater, 93311
        • Strategos Medical Group
      • Burbank, California, Forenede Stater, 91505
        • Providence Clinical Research
      • Cudahy, California, Forenede Stater, 90201
        • Rx for Life, Inc
      • Encino, California, Forenede Stater, 91436
        • Medical Group of Encino
      • Fountain Valley, California, Forenede Stater, 92708
        • Southland Clinical Research Center, Inc.
      • Fresno, California, Forenede Stater, 93720
        • Valley Research
      • Northridge, California, Forenede Stater, 91325
        • Diabetes Medical Center Of California
      • Pico Rivera, California, Forenede Stater, 90660
        • In Private Prictice Clinic
      • San Jose, California, Forenede Stater, 95128
        • San Jose Clinical Research, Inc.
    • Florida
      • Altamonte Springs, Florida, Forenede Stater, 32714
        • Central Florida Clinical Trials, Inc.
      • Melbourne, Florida, Forenede Stater, 32935
        • Accelovance
      • Sarasota, Florida, Forenede Stater, 34243
        • University Family Healthcare, Pa
      • St. Petersburg, Florida, Forenede Stater, 33707
        • Premier Healthcare
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66215
        • Pinnacle Medical Research
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64106
        • Kansas City University Of Medicine And Biosciences
      • Wentzville, Missouri, Forenede Stater, 63385
        • Primary Care Physicians, Pc
    • New Jersey
      • Toms River, New Jersey, Forenede Stater, 08755
        • Physicians Research Center
    • New York
      • Kingston, New York, Forenede Stater, 12401
        • Hudson Valley Clinical Research Center
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28262
        • Neem Research Group of Charlotte
      • Greenville, North Carolina, Forenede Stater, 27834
        • Diabetes Center- East Carolina University
      • Salisbury, North Carolina, Forenede Stater, 28144
        • Crescent Medical Research
    • Ohio
      • Barberton, Ohio, Forenede Stater, 44203
        • Community Health Care, Inc.
      • Canton, Ohio, Forenede Stater, 44718
        • Clinical Research Limited
      • Kettering, Ohio, Forenede Stater, 45429
        • Wells Institute for Health Awareness
      • Perrysburg, Ohio, Forenede Stater, 43551
        • Clinical Research Source, Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Accelovance
      • Oklahoma City, Oklahoma, Forenede Stater, 73170
        • Integris Family Care South
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97404
        • The Office Of Patricia Buchanan
    • Pennsylvania
      • Carlisle, Pennsylvania, Forenede Stater, 17015
        • Cumberland Valley Endocrinology Center, Llc
      • Fleetwood, Pennsylvania, Forenede Stater, 19522
        • Fleetwood Clinical Research
      • Pittsburgh, Pennsylvania, Forenede Stater, 15216
        • Banksville Medical, Pc
      • Shippensburg, Pennsylvania, Forenede Stater, 17257
        • Biomedical Research Associates, Llc
    • South Carolina
      • Duncan, South Carolina, Forenede Stater, 29334
        • Middle Tyger Family Medicine
      • Taylors, South Carolina, Forenede Stater, 29687
        • Southeastern Research Assoc
    • Tennessee
      • Bartlett, Tennessee, Forenede Stater, 38134
        • Versoza & Ungab Internal Medicine Associates
      • Collierville, Tennessee, Forenede Stater, 38017
        • Collierville Medical Specialist
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Holston Medical Group
      • Memphis, Tennessee, Forenede Stater, 38116
        • Med-South Research
      • Memphis, Tennessee, Forenede Stater, 38125
        • Southwind Medical Specialist
    • Texas
      • Carrollton, Texas, Forenede Stater, 75010
        • Precision Family Medicine
      • Corpus Christi, Texas, Forenede Stater, 78411
        • Alpha Therapy Research Center
      • Houston, Texas, Forenede Stater, 77081
        • Texas Center For Drug Development, P.A.
      • Houston, Texas, Forenede Stater, 77024
        • Village Family Practice
      • San Antonio, Texas, Forenede Stater, 78224
        • Abbott Clinical Research Group, Inc
    • Utah
      • Bountiful, Utah, Forenede Stater, 84010
        • Taylor/Wade Medical
      • Salt Lake City, Utah, Forenede Stater, 84102
        • Optimum Clinical Research
    • Virginia
      • Virginia Beach, Virginia, Forenede Stater, 23451
        • Tidewater Integrated Medical Research
    • Washington
      • Spokane, Washington, Forenede Stater, 99216
        • Spokane Internal Medicine
  • Indien
      • Bangalore, Indien, 560034
        • Local Institution
      • Mumbai, Indien, 400007
        • Local Institution
      • Mumbai, Indien, 400021
        • Local Institution
      • Nagpur, Indien, 440012
        • Local Institution
    • Karnataka
      • Manipal, Karnataka, Indien, 576104
        • Local Institution
    • Kerala
      • Kochi, Kerala, Indien, 682026
        • Local Institution
    • Mangalore
      • Attavar, Mangalore, Indien, 575001
        • Local Institution
    • New Delhi
      • Sarita Vihar, New Delhi, Indien, 110076
        • Local Institution
  • Taiwan
      • Changhua, Taiwan, 500
        • Local Institution
      • Kaohsiung County, Taiwan, 833
        • Local Institution
      • Taichung, Taiwan, 402
        • Local Institution
      • Taichung City, Taiwan, 407
        • Local Institution
      • Taipei City, Taiwan, 114
        • Local Institution
      • Tao-Yuan County, Taiwan, 333
        • Local Institution

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 77 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Type 2 diabetes
  • Inadequate blood sugar control

Exclusion Criteria:

  • Previous treatment for diabetes
  • Current treatment with other medications to lower blood sugar
  • Major heart, liver or kidney problems
  • Women who are pregnant or breastfeeding

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
Eksperimentel: Saxagliptin 2.5 mg QAM (A)
PLUS open-label metformin (as needed as rescue medication)
Medicin: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Eksperimentel: Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
PLUS open-label metformin (as needed as rescue medication)
Medicin: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Eksperimentel: Saxagliptin 5 mg QAM (C)
PLUS open-label metformin (as needed as rescue medication)
Medicin: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Eksperimentel: Saxagliptin 5 mg QPM (D)
PLUS open-label metformin (as needed as rescue medication)
Medicin: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Andre navne:
  • BMS-477118
Medicin: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Placebo komparator: Placebo (E)
PLUS open-label metformin (as needed as rescue medication)
Medicin: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Medicin: Placebo
Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Tidsramme: Baseline, Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Baseline, Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Tidsramme: Baseline, Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Baseline, Week 24
Ændring fra baseline i fastende plasmaglukose (FPG) i uge 24
Tidsramme: Baseline, uge ​​24
Gennemsnitlig ændring fra baseline i FPG i uge 24, justeret for basislinjeværdi.
Baseline, uge ​​24
Percentage of Participants Achieving A1C < 7% at Week 24
Tidsramme: Week 24
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.
Week 24
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Tidsramme: Baseline, Week 24
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Baseline, Week 24

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. juni 2006

Primær færdiggørelse (Faktiske)

1. november 2007

Studieafslutning (Faktiske)

1. november 2008

Datoer for studieregistrering

Først indsendt

18. april 2006

Først indsendt, der opfyldte QC-kriterier

19. april 2006

Først opslået (Skøn)

20. april 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. april 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CV181-038

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 Saxagliptin

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Italy

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner