Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

9. september 2011 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

252

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: 1
placebo, oral tablet administered once daily on background of pioglitazone
Legemiddel: Placebo
placebo, oral tablet administered once daily on background of pioglitazone
Eksperimentell: 2
dutogliptin, oral tablet administered once daily on background of pioglitazone
Legemiddel: Dutogliptin
dutogliptin, oral tablet administered once daily on background of pioglitazone

Hva måler studien?

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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Forest Laboratories

Samarbeidspartnere

Phenomix

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2009

Primær fullføring (Faktiske)

1. august 2010

Datoer for studieregistrering

Først innsendt

1. september 2009

Først innsendt som oppfylte QC-kriteriene

1. september 2009

Først lagt ut (Anslag)

2. september 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

21. september 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2011

Sist bekreftet

1. september 2011

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DUT-MD-304

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere