A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
5. oktober 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
48
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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California
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Chula Vista, California, Forente stater, 91911
- Pfizer Investigational Site
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Florida
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DeLand, Florida, Forente stater, 32720
- Pfizer Investigational Site
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Miami Gardens, Florida, Forente stater, 33169
- Pfizer Investigational Site
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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 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: placebo
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Matching placebo giving for 4 weeks
|
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Eksperimentell: PF-04620110
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5 mg of PF-04620110 given once daily
2.5 mg of PF-04620110 given twice daily
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
|
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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
|
|
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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
|
|
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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
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Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
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Baseline (Day -1); 6 to 10 hours post-dose on Day 28
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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.
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Baseline (Day -1); 12 to 16 hours post-dose on Day 28
|
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Maximum Observed Plasma Concentration (Cmax) of PF-04620110
Tidsramme: 24 hours post-morning dose on Day 28
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24 hours post-morning dose on Day 28
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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
|
|
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Time to Cmax (Tmax) of PF-04620110
Tidsramme: 24 hours post-morning dose on Day 28
|
24 hours post-morning dose on Day 28
|
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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
|
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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. februar 2011
Primær fullføring (Faktiske)
1. mai 2011
Studiet fullført (Faktiske)
1. mai 2011
Datoer for studieregistrering
Først innsendt
28. januar 2011
Først innsendt som oppfylte QC-kriteriene
16. februar 2011
Først lagt ut (Anslag)
17. februar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. november 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. oktober 2012
Sist bekreftet
1. oktober 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B0961007
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