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Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)

8. november 2019 opdateret af: Merck Sharp & Dohme LLC

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Single Day Evaluation Of The Pharmacokinetic-Pharmacodynamic Effect Of Once And Twice Daily Oral Administration Of PF-04971729 In Patients With Type 2 Diabetes Mellitus

This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered once vs twice daily (morning [AM] and evening [PM]) in adults with type 2 diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

52

Fase

  • Fase 1

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.

Exclusion Criteria:

  • Participants with type 1 diabetes mellitus, participants with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1: Ertu 2 mg/Placebo (Pbo)→Ertu 1 mg/Ertu 1 mg
Period 1: Ertu 2 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
Medicin: Ertugliflozin 2 mg single dose
Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
Medicin: Ertugliflozin 2 mg split into twice daily
Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
Medicin: Placebo
Placebo to ertugliflozin administered as a single dose
Eksperimentel: Cohort 1: Ertu 1 mg/Ertu 1 mg→Ertu 2 mg/Pbo
Period 1: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Pbo in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
Medicin: Ertugliflozin 2 mg single dose
Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
Medicin: Ertugliflozin 2 mg split into twice daily
Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
Medicin: Placebo
Placebo to ertugliflozin administered as a single dose
Eksperimentel: Cohort 2: Ertu 4 mg/Pbo→Ertu 2 mg/Ertu 2 mg
Period 1: Ertu 4 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
Medicin: Placebo
Placebo to ertugliflozin administered as a single dose
Medicin: Ertugliflozin 4 mg single dose
Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
Medicin: Ertugliflozin 4 mg split into twice daily
Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
Eksperimentel: Cohort 2: Ertu 2 mg/Ertu 2 mg→Ertu 4 mg/Pbo
Period 1: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. Period 2: Ertu 4 mg in the AM and Pbo in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
Medicin: Placebo
Placebo to ertugliflozin administered as a single dose
Medicin: Ertugliflozin 4 mg single dose
Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
Medicin: Ertugliflozin 4 mg split into twice daily
Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cumulative Urinary Glucose Excretion Over 0 to 24 Hours
Tidsramme: 0 to 24 hours after the morning dose
Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted from 0 to 24 hours after the morning dose is presented in the table below.
0 to 24 hours after the morning dose
Urinary Glucose Excretion by Time Period
Tidsramme: At 0-4 hrs, 4-8 hrs, 8-12 hrs, and 12-24 hrs after the AM dose (up to 24 hours)
Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted during the pre-specified time frame is presented in the table below.
At 0-4 hrs, 4-8 hrs, 8-12 hrs, and 12-24 hrs after the AM dose (up to 24 hours)
24-hour Weighted Mean Plasma Glucose
Tidsramme: Up to 24 hours
Blood was collected during each treatment period at pre-dose (fasted) on Day 1 (Hour 0) and post-dose (fed) on Day 1 at 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 12.5, 13, 14, 15, 16, 18, and 24 hours.
Up to 24 hours
Weighted Mean Postprandial Plasma Glucose
Tidsramme: At 0-5 hours, 5-12 hrs, and 12-18 hrs after the morning dose (up to 18 hours)
The weighted mean postprandial glucose over the specified intervals were analyzed by cohort.
At 0-5 hours, 5-12 hrs, and 12-18 hrs after the morning dose (up to 18 hours)
Fasting Plasma Glucose
Tidsramme: Up to 24 hours
Blood samples were to be collected following a fast from all food and drink (except water) for at least 8 hours. Fasting Plasma Glucose was collected as part of the assessment of weighted mean 24-hour plasma glucose. As such, it was not specified as an endpoint in the Statistical Analysis Plan and was not analyzed or summarized separately.
Up to 24 hours
Fasting C-peptide
Tidsramme: Up to 24 hours (0 and 24 hours)
The fasting c-peptide was analyzed by cohort using a mixed-effects model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.
Up to 24 hours (0 and 24 hours)
Number of Participants Experiencing an Adverse Event
Tidsramme: Up to 16 days
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug.
Up to 16 days
Number of Participants Discontinuing Study Drug Due to an Adverse Event
Tidsramme: Up to 8 days (Day 1 in each dosing period)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug. Data include participants discontinued due to adverse events, participants with dose reduced or temporary discontinuation due to adverse events.
Up to 8 days (Day 1 in each dosing period)
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin
Tidsramme: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
Pharmacokinetic (PK) parameter of AUClast for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
Maximum Plasma Concentration (Cmax) of Ertugliflozin
Tidsramme: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
PK parameter of Cmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin
Tidsramme: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
PK parameter of Tmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose

Samarbejdspartnere og efterforskere

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

Sponsor

Merck Sharp & Dohme LLC

Samarbejdspartnere

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.

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 (Faktiske)

17. februar 2010

Primær færdiggørelse (Faktiske)

7. april 2010

Studieafslutning (Faktiske)

7. april 2010

Datoer for studieregistrering

Først indsendt

20. januar 2010

Først indsendt, der opfyldte QC-kriterier

20. januar 2010

Først opslået (Skøn)

22. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 8835-040
  • B1521007 (Anden identifikator: Pfizer Protocol Number)
  • MK-8835-040 (Anden identifikator: Merck Protocol Number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 2

Kliniske forsøg med Ertugliflozin 2 mg single dose

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