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

keskiviikko 15. elokuuta 2018 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

375

Vaihe

  • Vaihe 2

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 70 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Placebo Comparator: Placebo
Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
Lääke: 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
Lääke: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Lääke: 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).
Muut nimet:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Kokeellinen: 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
Lääke: 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
Lääke: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Lääke: 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).
Muut nimet:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Lääke: Ertugliflozin 1 mg
Tablet, 1 mg, once daily for 84 days
Kokeellinen: 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
Lääke: 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
Lääke: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Lääke: 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).
Muut nimet:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Lääke: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Kokeellinen: Ertugliflozin 10 mg
Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
Lääke: 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
Lääke: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Lääke: 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).
Muut nimet:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Lääke: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Kokeellinen: Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
Lääke: 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
Lääke: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Lääke: 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).
Muut nimet:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Lääke: Ertugliflozin 25 mg
Tablet, 25 mg, once daily for 84 days
Active Comparator: Sitagliptin 100 mg
Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
Lääke: 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
Lääke: 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).
Muut nimet:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Lääke: Sitagliptin 100 mg
Tablet, 100 mg, once daily for 84 days
Muut nimet:
  • Januvia®, Tesavel®, Xelevia®, Ristaben®

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Baseline Hemoglobin A1c (HbA1c)
Aikaikkuna: Baseline
HbA1c is measured as percent.
Baseline
Change From Baseline in HbA1c at Week 12
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline in HbA1C at Week 2
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline
Baseline
Percent Change From Baseline in Body Weight at Week 12
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Baseline
Change From Baseline in Fasting Plasma Glucose at Week 12
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Merck Sharp & Dohme LLC

Yhteistyökumppanit

Pfizer

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Keskiviikko 24. helmikuuta 2010

Ensisijainen valmistuminen (Todellinen)

Torstai 20. tammikuuta 2011

Opintojen valmistuminen (Todellinen)

Torstai 20. tammikuuta 2011

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 29. tammikuuta 2010

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 29. tammikuuta 2010

Ensimmäinen Lähetetty (Arvio)

Maanantai 1. helmikuuta 2010

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 13. syyskuuta 2018

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 15. elokuuta 2018

Viimeksi vahvistettu

Keskiviikko 1. elokuuta 2018

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 8835-016
  • B1521006 (Muu tunniste: Pfizer protocol number)
  • 2009-017131-18 (EudraCT-numero)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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Kliiniset tutkimukset Diabetes mellitus, tyyppi 2

Kliiniset tutkimukset Placebo to Ertugliflozin

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Malawi

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

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