Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

15 augustus 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

375

Fase

  • Fase 2

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
Geneesmiddel: 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
Geneesmiddel: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Geneesmiddel: 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).
Andere namen:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Experimenteel: 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
Geneesmiddel: 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
Geneesmiddel: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Geneesmiddel: 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).
Andere namen:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Geneesmiddel: Ertugliflozin 1 mg
Tablet, 1 mg, once daily for 84 days
Experimenteel: 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
Geneesmiddel: 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
Geneesmiddel: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Geneesmiddel: 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).
Andere namen:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Geneesmiddel: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Experimenteel: Ertugliflozin 10 mg
Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
Geneesmiddel: 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
Geneesmiddel: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Geneesmiddel: 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).
Andere namen:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Geneesmiddel: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Experimenteel: Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
Geneesmiddel: 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
Geneesmiddel: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Geneesmiddel: 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).
Andere namen:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Geneesmiddel: Ertugliflozin 25 mg
Tablet, 25 mg, once daily for 84 days
Actieve vergelijker: Sitagliptin 100 mg
Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
Geneesmiddel: 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
Geneesmiddel: 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).
Andere namen:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Geneesmiddel: Sitagliptin 100 mg
Tablet, 100 mg, once daily for 84 days
Andere namen:
  • Januvia®, Tesavel®, Xelevia®, Ristaben®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Baseline Hemoglobin A1c (HbA1c)
Tijdsspanne: Baseline
HbA1c is measured as percent.
Baseline
Change From Baseline in HbA1c at Week 12
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in HbA1C at Week 2
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
Baseline
Percent Change From Baseline in Body Weight at Week 12
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Baseline
Change From Baseline in Fasting Plasma Glucose at Week 12
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Medewerkers

Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 februari 2010

Primaire voltooiing (Werkelijk)

20 januari 2011

Studie voltooiing (Werkelijk)

20 januari 2011

Studieregistratiedata

Eerst ingediend

29 januari 2010

Eerst ingediend dat voldeed aan de QC-criteria

29 januari 2010

Eerst geplaatst (Schatting)

1 februari 2010

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 september 2018

Laatste update ingediend die voldeed aan QC-criteria

15 augustus 2018

Laatst geverifieerd

1 augustus 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Diabetes mellitus, type 2

Klinische onderzoeken op Placebo to Ertugliflozin

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Cambodia

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren