Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

8 novembre 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

52

Phase

  • La phase 1

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Ertugliflozin 2 mg single dose
Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
Médicament: Ertugliflozin 2 mg split into twice daily
Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
Médicament: Placebo
Placebo to ertugliflozin administered as a single dose
Expérimental: 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.
Médicament: Ertugliflozin 2 mg single dose
Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
Médicament: Ertugliflozin 2 mg split into twice daily
Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
Médicament: Placebo
Placebo to ertugliflozin administered as a single dose
Expérimental: 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.
Médicament: Placebo
Placebo to ertugliflozin administered as a single dose
Médicament: Ertugliflozin 4 mg single dose
Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
Médicament: Ertugliflozin 4 mg split into twice daily
Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
Expérimental: 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.
Médicament: Placebo
Placebo to ertugliflozin administered as a single dose
Médicament: Ertugliflozin 4 mg single dose
Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
Médicament: Ertugliflozin 4 mg split into twice daily
Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Cumulative Urinary Glucose Excretion Over 0 to 24 Hours
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Merck Sharp & Dohme LLC

Collaborateurs

Pfizer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

17 février 2010

Achèvement primaire (Réel)

7 avril 2010

Achèvement de l'étude (Réel)

7 avril 2010

Dates d'inscription aux études

Première soumission

20 janvier 2010

Première soumission répondant aux critères de contrôle qualité

20 janvier 2010

Première publication (Estimation)

22 janvier 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 novembre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 novembre 2019

Dernière vérification

1 novembre 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 8835-040
  • B1521007 (Autre identifiant: Pfizer Protocol Number)
  • MK-8835-040 (Autre identifiant: Merck Protocol Number)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Diabète sucré, Type 2

Essais cliniques sur Ertugliflozin 2 mg single dose

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Taiwan

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
S'abonner