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Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone

9. september 2011 opdateret af: Forest Laboratories

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Pioglitazone

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

252

Fase

  • Fase 3

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, 35205
        • Forest Investigative Site 064
      • Birmingham, Alabama, Forenede Stater, 35235
        • Forest Investigative Site 020
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85225
        • Forest Investigative Site 059
      • Litchfield, Arizona, Forenede Stater, 85340
        • Forest Investigative Site 096
      • Phoenix, Arizona, Forenede Stater, 85020
        • Forest Investigative Site 098
      • Scottsdale, Arizona, Forenede Stater, 85254
        • Forest Investigative Site 044
      • Tucson, Arizona, Forenede Stater, 85741
        • Forest Investigative Site 087
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Forest Investigative Site 061
      • Chula Vista, California, Forenede Stater, 91911
        • Forest Investigative Site 041
      • Encinitas, California, Forenede Stater, 92024
        • Forest Investigative Site 049
      • Greenbrae, California, Forenede Stater, 94904
        • Forest Investigative Site 022
      • Harbor City, California, Forenede Stater, 90710
        • Forest Investigative Site 047
      • Huntington Park, California, Forenede Stater, 90255
        • Forest Investigative Site 010
      • Northridge, California, Forenede Stater, 91325
        • Forest Investigative Site 111
      • Riverside, California, Forenede Stater, 92506
        • Forest Investigative Site 031
      • Roseville, California, Forenede Stater, 95661
        • Forest Investigative Site 091
      • Sacramento, California, Forenede Stater, 95821
        • Forest Investigative Site 067
      • Santa Ana, California, Forenede Stater, 92701
        • Forest Investigative Site 112
      • Walnut Creek, California, Forenede Stater, 94598
        • Forest Investigative Site 011
      • West Hills, California, Forenede Stater, 91307
        • Forest Investigative Site 063
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80910
        • Forest Investigative Site 115
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
        • Forest Investigative Site 073
      • Daytona Beach, Florida, Forenede Stater, 32117
        • Forest Investigative Site 004
      • DeLand, Florida, Forenede Stater, 32720
        • Forest Investigative Site 052
      • Jacksonville, Florida, Forenede Stater, 32205
        • Forest Investigative Site 062
      • Miami, Florida, Forenede Stater, 33169
        • Forest Investigative Site 021
      • Miami, Florida, Forenede Stater, 33186
        • Forest Investigative Site 122
      • Miami, Florida, Forenede Stater, 33183
        • Forest Investigative Site 050
      • Orlando, Florida, Forenede Stater, 32806
        • Forest Investigative Site 015
      • Sarasota, Florida, Forenede Stater, 34239
        • Forest Investigative Site 018
      • St. Petersburg, Florida, Forenede Stater, 33716
        • Forest Investigative Site 075
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Forest Investigative Site 026
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30338
        • Forest Investigative Site 045
      • Augusta, Georgia, Forenede Stater, 30909
        • Forest Investigative Site 079
    • Idaho
      • Meridian, Idaho, Forenede Stater, 83646
        • Forest Investigative Site 009
    • Illinois
      • Melrose Park, Illinois, Forenede Stater, 60160
        • Forest Investigative Site 60
      • Peoria, Illinois, Forenede Stater, 61614
        • Forest Investigative Site 030
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47710
        • Forest Investigative Site 100
      • Evansville, Indiana, Forenede Stater, 47713
        • Forest Investigative Site 097
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Forest Investigative Site 053
      • Wichita, Kansas, Forenede Stater, 67203
        • Forest Investigative Site 008
    • Kentucky
      • Erlanger, Kentucky, Forenede Stater, 41018
        • Forest Investigative Site 078
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Forest Investigative Site 024
    • Louisiana
      • Covington, Louisiana, Forenede Stater, 70433
        • Forest Investigative Site 034
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21204
        • Forest Investigative Site 035
      • Oxon Hill, Maryland, Forenede Stater, 20745
        • Forest Investigative Site 046
    • Massachusetts
      • New Bedford, Massachusetts, Forenede Stater, 02740
        • Forest Investigative Site 118
      • Waltham, Massachusetts, Forenede Stater, 02453
        • Forest Investigative Site 007
    • Michigan
      • Dearborn, Michigan, Forenede Stater, 48126
        • Forest Investigative Site 002
      • St. Clair Shores, Michigan, Forenede Stater, 48081
        • Forest Investigative Site 029
    • Minnesota
      • Edina, Minnesota, Forenede Stater, 55435
        • Forest Investigative Site 054
    • Nebraska
      • Grand Island, Nebraska, Forenede Stater, 68803
        • Forest Investigative Site 013
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89101
        • Forest Investigative Site 072
      • Las Vegas, Nevada, Forenede Stater, 89117
        • Forest Investigative Site 065
    • New York
      • New Hyde Park, New York, Forenede Stater, 11042
        • Forest Investigative Site 081
      • New York, New York, Forenede Stater, 10019
        • Forest Investigative Site 016
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Forest Investigative Site 094
      • Charlotte, North Carolina, Forenede Stater, 28209
        • Forest Investigative Site 051
      • Charlotte, North Carolina, Forenede Stater, 28277
        • Forest Investigative Site 117
      • Lenoir, North Carolina, Forenede Stater, 28645
        • Forest Investigative Site 058
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Forest Investigative Site 038
      • Salisbury, North Carolina, Forenede Stater, 28144
        • Forest Investigative Site 040
    • Ohio
      • Akron, Ohio, Forenede Stater, 44311
        • Forest Investigative Site 039
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Forest Investigative Site 023
      • Columbus, Ohio, Forenede Stater, 43201
        • Forest Investigative Site 043
      • Dayton, Ohio, Forenede Stater, 45406
        • Forest Investigative Site 057
      • Kettering, Ohio, Forenede Stater, 45429
        • Forest Investigative Site 032
    • Oklahoma
      • Norman, Oklahoma, Forenede Stater, 73069
        • Forest Investigative Site 149
    • Oregon
      • Ashland, Oregon, Forenede Stater, 97520
        • Forest Investigative Site 102
      • Eugene, Oregon, Forenede Stater, 97404
        • Forest Investigative Site 005
    • Pennsylvania
      • Harleysville, Pennsylvania, Forenede Stater, 19438
        • Forest Investigative Site 037
      • Philadelphia, Pennsylvania, Forenede Stater, 19152
        • Forest Investigative Site 066
      • Tipton, Pennsylvania, Forenede Stater, 16684
        • Forest Investigative Site 036
    • South Carolina
      • Greer, South Carolina, Forenede Stater, 29651
        • Forest Investigative Site 103
      • Manning, South Carolina, Forenede Stater, 29102
        • Forest Investigative Site 090
      • Pelzer, South Carolina, Forenede Stater, 29669
        • Forest Investigative Site 033
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Forest Investigative Site 114
      • Chattanooga, Tennessee, Forenede Stater, 37421
        • Forest Investigative Site 104
    • Texas
      • Arlington, Texas, Forenede Stater, 76014
        • Forest Investigative Site 099
      • Corpus Christi, Texas, Forenede Stater, 78404
        • Forest Investigative Site 056
      • Dallas, Texas, Forenede Stater, 75235
        • Forest Investigative Site 017
      • Dallas, Texas, Forenede Stater, 75251
        • Forest Investigative Site 124
      • Houston, Texas, Forenede Stater, 77079
        • Forest Investigative Site 106
      • Irving, Texas, Forenede Stater, 75039
        • Forest Investigative Site 014
      • San Antonio, Texas, Forenede Stater, 78229
        • Forest Investigative Site 109
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84107
        • Forest Investigative Site 076
    • Virginia
      • Virginia Beach, Virginia, Forenede Stater, 23454
        • Forest Investigative Site 028
    • Washington
      • Spokane, Washington, Forenede Stater, 99207
        • Forest Investigative Site 092
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Forest Investigative Site 027
  • Hviderusland
      • Mogilev, Hviderusland, 212030
        • Forest Investigative Site 209
  • Indien
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, Indien, 520002
        • Forest Investigative Site 614
    • Gujarat
      • Ahmedabad, Gujarat, Indien, 380015
        • Forest Investigative Site 618
    • Karnal
      • Haryana, Karnal, Indien, 132001
        • Forest Investigative Site 620
    • Karnataka
      • Bangalore, Karnataka, Indien, 560003
        • Forest Investigative Site 607
      • Bangalore, Karnataka, Indien, 560010
        • Forest Investigative Site 606
      • Bangalore, Karnataka, Indien, 560043
        • Forest Investigative Site 602
      • Bangalore, Karnataka, Indien, 560092
        • Forest Investigative Site 604
      • Mangalore, Karnataka, Indien, 575003
        • Forest Investigative Site 601
    • Maharashtra
      • Nagpur, Maharashtra, Indien, 440012
        • Forest Investigative Site 616
      • Nasik, Maharashtra, Indien, 380015
        • Forest Investigative Site 617
      • Pune, Maharashtra, Indien, 411037
        • Forest Investigative Site 612
    • Tamil Nadu
      • Channi, Tamil Nadu, Indien, 600020
        • Forest Investigative Site 603
      • Chennai, Tamil Nadu, Indien, 600013
        • Forest Investigative Site 613
      • Vellore, Tamil Nadu, Indien, 632009
        • Forest Investigative Site 615
  • Litauen
    • Lithunia
      • Kaunas, Lithunia, Litauen, 48259
        • Forest Investigative Site 702
      • Kaunas, Lithunia, Litauen, 49456
        • Forest Investigative Site 703
      • Klaipeda, Lithunia, Litauen, 92288
        • Forest Investigative Site 704
      • Vilnius, Lithunia, Litauen, 09112
        • Forest Investigative Site 705
  • Rumænien
      • Bacau, Rumænien, 600164
        • Forest Investigative Site 909
      • Bucuresti, Rumænien, 010584
        • Forest Investigative Site 906
      • Bucuresti, Rumænien, 020725
        • Forest Investigative Site 908
      • Satu Mare, Rumænien, 440055
        • Forest Investigative Site 903
      • Sibiu, Rumænien, 550245
        • Forest Investigative Site 901
      • Tg Mures, Rumænien, 540142
        • Forest Investigative Site 905 Romania
      • Timisoara, Rumænien, 300736
        • Forest Investigative Site 902
  • Tyskland
      • Dresden, Tyskland, 01099
        • Forest Investigative Site 401
      • Dresden, Tyskland, 01307
        • Forest Investigative Site 402
      • Mainz, Tyskland, 55116
        • Forest Investigative Site 403

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 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
  • BMI 20 to 48 kg/m2, inclusive
  • HbA1c 7.0% - 10.0%, inclusive
  • Age 18 to 85 years, inclusive

Exclusion Criteria:

  • Currently taking more than one oral hypoglycemic agent
  • Type 1 diabetes mellitus

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: 1
placebo, oral tablet administered once daily on background of pioglitazone
Medicin: Placebo
placebo, oral tablet administered once daily on background of pioglitazone
Eksperimentel: 2
dutogliptin, oral tablet administered once daily on background of pioglitazone
Medicin: Dutogliptin
dutogliptin, oral tablet administered once daily on background of pioglitazone

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Hemoglobin A1c Level (HbA1c)
Tidsramme: HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26)
HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26)

Sekundære resultatmål

Resultatmål
Tidsramme
Fasting Plasma Glucose Level (FPG)
Tidsramme: FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26).
FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26).

Samarbejdspartnere og efterforskere

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

Sponsor

Forest Laboratories

Samarbejdspartnere

Phenomix

Efterforskere

  • Studieleder: Kaity Posada, PharmD, Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

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 2009

Primær færdiggørelse (Faktiske)

1. august 2010

Datoer for studieregistrering

Først indsendt

1. september 2009

Først indsendt, der opfyldte QC-kriterier

1. september 2009

Først opslået (Skøn)

2. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. september 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2011

Sidst verificeret

1. september 2011

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DUT-MD-304

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 II

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Switzerland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner