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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 августа 2018 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

375

Фаза

  • Фаза 2

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 70 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: Placebo
Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
Лекарство: 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
Лекарство: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Лекарство: 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).
Другие имена:
  • Фортамет®, Глюкофаж®, Глюкофаж® XR, Глюметза®, Риомет®, Метглюко®, Гликоран®
Экспериментальный: 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
Лекарство: 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
Лекарство: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Лекарство: 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).
Другие имена:
  • Фортамет®, Глюкофаж®, Глюкофаж® XR, Глюметза®, Риомет®, Метглюко®, Гликоран®
Лекарство: Ertugliflozin 1 mg
Tablet, 1 mg, once daily for 84 days
Экспериментальный: 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
Лекарство: 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
Лекарство: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Лекарство: 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).
Другие имена:
  • Фортамет®, Глюкофаж®, Глюкофаж® XR, Глюметза®, Риомет®, Метглюко®, Гликоран®
Лекарство: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Экспериментальный: Ertugliflozin 10 mg
Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
Лекарство: 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
Лекарство: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Лекарство: 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).
Другие имена:
  • Фортамет®, Глюкофаж®, Глюкофаж® XR, Глюметза®, Риомет®, Метглюко®, Гликоран®
Лекарство: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Экспериментальный: Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
Лекарство: 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
Лекарство: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Лекарство: 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).
Другие имена:
  • Фортамет®, Глюкофаж®, Глюкофаж® XR, Глюметза®, Риомет®, Метглюко®, Гликоран®
Лекарство: Ertugliflozin 25 mg
Tablet, 25 mg, once daily for 84 days
Активный компаратор: Sitagliptin 100 mg
Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
Лекарство: 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
Лекарство: 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).
Другие имена:
  • Фортамет®, Глюкофаж®, Глюкофаж® XR, Глюметза®, Риомет®, Метглюко®, Гликоран®
Лекарство: Sitagliptin 100 mg
Tablet, 100 mg, once daily for 84 days
Другие имена:
  • Янувия®, Тесавел®, Кселевия®, Ристабен®

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Baseline Hemoglobin A1c (HbA1c)
Временное ограничение: Baseline
HbA1c is measured as percent.
Baseline
Change From Baseline in HbA1c at Week 12
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline in HbA1C at Week 2
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline
Baseline
Percent Change From Baseline in Body Weight at Week 12
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Baseline
Change From Baseline in Fasting Plasma Glucose at Week 12
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Merck Sharp & Dohme LLC

Соавторы

Pfizer

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

24 февраля 2010 г.

Первичное завершение (Действительный)

20 января 2011 г.

Завершение исследования (Действительный)

20 января 2011 г.

Даты регистрации исследования

Первый отправленный

29 января 2010 г.

Впервые представлено, что соответствует критериям контроля качества

29 января 2010 г.

Первый опубликованный (Оценивать)

1 февраля 2010 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

13 сентября 2018 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

15 августа 2018 г.

Последняя проверка

1 августа 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 8835-016
  • B1521006 (Другой идентификатор: Pfizer protocol number)
  • 2009-017131-18 (Номер EudraCT)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Placebo to Ertugliflozin

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