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A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

5. oktober 2012 opdateret af: Pfizer

A Phase 1B, Randomized, Double-Blind, Placebo-Controlled Trial To Assess The Efficacy And Safety Of 4-Week Administration Of Multiple Oral Doses Of PF-04620110 In Type 2 Diabetes Mellitus Subjects With Insufficient Glycemic Control On Metformin

PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Chula Vista, California, Forenede Stater, 91911
        • Pfizer Investigational Site
    • Florida
      • DeLand, Florida, Forenede Stater, 32720
        • Pfizer Investigational Site
      • Miami Gardens, Florida, Forenede Stater, 33169
        • 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

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male and/or female subjects between the ages of 18 and 60 years;
  • Body Mass Index (BMI) of >25.0 kg/m2 and <40 kg/m2;
  • Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;
  • Subjects who have been on well-tolerated and stable doses of metformin

Exclusion Criteria:

  • Recent evidence (6 months prior to screening) or history of unstable major organ disease;
  • Diagnosis of Type 1 diabetes mellitus;
  • Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;
  • Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: placebo
Medicin: Placebo
Matching placebo giving for 4 weeks
Eksperimentel: PF-04620110
Medicin: PF-04620110
5 mg of PF-04620110 given once daily
Medicin: PF-04620110
2.5 mg of PF-04620110 given twice daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Tidsramme: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28
Tidsramme: Baseline (Day -1); 24 hours post-dose on Day 28
APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.
Baseline (Day -1); 24 hours post-dose on Day 28
Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Tidsramme: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Tidsramme: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28
Tidsramme: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
Tidsramme: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
Tidsramme: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28
Tidsramme: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Fasting Glucose at Day 28
Tidsramme: 0 hour (pre-dose) on Day -1, Day 28
0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Fasting Insulin at Day 28
Tidsramme: 0 hour (pre-dose) on Day -1, Day 28
0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Fasting Net Triglycerides at Day 28
Tidsramme: 0 hour (pre-dose) on Day -1, Day 28
0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28
Tidsramme: Baseline (Day -1); 6 to 10 hours post-dose on Day 28
Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
Baseline (Day -1); 6 to 10 hours post-dose on Day 28
Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28
Tidsramme: Baseline (Day -1); 12 to 16 hours post-dose on Day 28
Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
Baseline (Day -1); 12 to 16 hours post-dose on Day 28
Maximum Observed Plasma Concentration (Cmax) of PF-04620110
Tidsramme: 24 hours post-morning dose on Day 28
24 hours post-morning dose on Day 28
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110
Tidsramme: 24 hours post-morning dose on Day 28
24 hours post-morning dose on Day 28
Time to Cmax (Tmax) of PF-04620110
Tidsramme: 24 hours post-morning dose on Day 28
24 hours post-morning dose on Day 28
Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110
Tidsramme: 24 hours post-morning dose on Day 28

Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours.

AUC (0-24) was computed using the linear trapezoidal method.
24 hours post-morning dose on Day 28

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

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. februar 2011

Primær færdiggørelse (Faktiske)

1. maj 2011

Studieafslutning (Faktiske)

1. maj 2011

Datoer for studieregistrering

Først indsendt

28. januar 2011

Først indsendt, der opfyldte QC-kriterier

16. februar 2011

Først opslået (Skøn)

17. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B0961007

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 Type 2-diabetespatienter

Kliniske forsøg med PF-04620110

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Peru

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner