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Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

15. august 2018 opdateret af: Merck Sharp & Dohme LLC

A 12-Week, Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety, Tolerability and Efficacy Of Once Daily PF-04971729 And Sitagliptin On Glycemic Control And Body Weight In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

375

Fase

  • Fase 2

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 70 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 on stable doses of background medicines for management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m^2

Exclusion Criteria:

  • Participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease

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: Placebo
Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
Medicin: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Medicin: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Medicin: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Andre navne:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Eksperimentel: Ertugliflozin 1 mg
Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
Medicin: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Medicin: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Medicin: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Andre navne:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Medicin: Ertugliflozin 1 mg
Tablet, 1 mg, once daily for 84 days
Eksperimentel: Ertugliflozin 5 mg
Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
Medicin: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Medicin: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Medicin: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Andre navne:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Medicin: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Eksperimentel: Ertugliflozin 10 mg
Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
Medicin: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Medicin: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Medicin: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Andre navne:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Medicin: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Eksperimentel: Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
Medicin: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Medicin: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Medicin: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Andre navne:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Medicin: Ertugliflozin 25 mg
Tablet, 25 mg, once daily for 84 days
Aktiv komparator: Sitagliptin 100 mg
Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
Medicin: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Medicin: Metformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Andre navne:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Medicin: Sitagliptin 100 mg
Tablet, 100 mg, once daily for 84 days
Andre navne:
  • Januvia®, Tesavel®, Xelevia®, Ristaben®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Baseline Hemoglobin A1c (HbA1c)
Tidsramme: Baseline
HbA1c is measured as percent.
Baseline
Change From Baseline in HbA1c at Week 12
Tidsramme: Baseline and Week 12
HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]).
Baseline and Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in HbA1C at Week 2
Tidsramme: Baseline and Week 2
HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
Baseline and Week 2
Change From Baseline in HbA1c at Week 4
Tidsramme: Baseline and Week 4
HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
Baseline and Week 4
Change From Baseline in HbA1c at Week 8
Tidsramme: Baseline and Week 8
HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
Baseline and Week 8
Baseline Body Weight
Tidsramme: Baseline
Baseline
Percent Change From Baseline in Body Weight at Week 12
Tidsramme: Baseline and Week 12
The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
Baseline and Week 12
Percent Change From Baseline in Body Weight at Week 2
Tidsramme: Baseline and Week 2
The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
Baseline and Week 2
Percent Change From Baseline in Body Weight at Week 4
Tidsramme: Baseline and Week 4
The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
Baseline and Week 4
Percent Change From Baseline in Body Weight at Week 8
Tidsramme: Baseline and Week 8
The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
Baseline and Week 8
Baseline Systolic Blood Pressure
Tidsramme: Baseline
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
Baseline
Change From Baseline in Systolic Blood Pressure at Week 12
Tidsramme: Baseline and Week 12
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
Baseline and Week 12
Change From Baseline in Systolic Blood Pressure at Week 2
Tidsramme: Baseline and Week 2
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
Baseline and Week 2
Change From Baseline in Systolic Blood Pressure at Week 4
Tidsramme: Baseline and Week 4
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
Baseline and Week 4
Change From Baseline in Systolic Blood Pressure at Week 8
Tidsramme: Baseline and Week 8
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
Baseline and Week 8
Baseline Diastolic Blood Pressure
Tidsramme: Baseline
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
Baseline
Change From Baseline in Diastolic Blood Pressure at Week 12
Tidsramme: Baseline and Week 12
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure at Week 2
Tidsramme: Baseline and Week 2
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
Baseline and Week 2
Change From Baseline in Diastolic Blood Pressure at Week 4
Tidsramme: Baseline and Week 4
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
Baseline and Week 4
Change From Baseline in Diastolic Blood Pressure at Week 8
Tidsramme: Baseline and Week 8
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
Baseline and Week 8
Baseline Fasting Plasma Glucose
Tidsramme: Baseline
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Baseline
Change From Baseline in Fasting Plasma Glucose at Week 12
Tidsramme: Baseline and Week 12
The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Baseline and Week 12
Change From Baseline in Fasting Plasma Glucose at Week 2
Tidsramme: Baseline and Week 2
The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Baseline and Week 2
Change From Baseline in Fasting Plasma Glucose at Week 4
Tidsramme: Baseline and Week 4
The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Baseline and Week 4
Change From Baseline in Fasting Plasma Glucose at Week 8
Tidsramme: Baseline and Week 8
The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Baseline and Week 8
Percentage of Participants Achieving HbA1c <7% at Week 12
Tidsramme: Week 12
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Week 12
Percentage of Participants Achieving HbA1C <6.5% at Week 12
Tidsramme: Week 12
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Week 12
Number of Participants Who Experienced an Advere Event (AE)
Tidsramme: Up to 98 days
An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin.
Up to 98 days
Number of Participants Who Discontinued Study Medication Due to an AE
Tidsramme: Up to 84 days
An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication.
Up to 84 days

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)

24. februar 2010

Primær færdiggørelse (Faktiske)

20. januar 2011

Studieafslutning (Faktiske)

20. januar 2011

Datoer for studieregistrering

Først indsendt

29. januar 2010

Først indsendt, der opfyldte QC-kriterier

29. januar 2010

Først opslået (Skøn)

1. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 8835-016
  • B1521006 (Anden identifikator: Pfizer protocol number)
  • 2009-017131-18 (EudraCT nummer)

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 Placebo to Ertugliflozin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Spain

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner