Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
6 сентября 2019 г. обновлено: Eli Lilly and Company
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes.
Patients will be treated for 24 months with a 2-month follow-up period.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
415
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Fortaleza, Бразилия, 60120-020
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Porto Alegre, Бразилия, 90035-003
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São Paulo, Бразилия, 04020041
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Budapest, Венгрия, H-1139
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Mako, Венгрия, 6900
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Veszprem, Венгрия, 8200
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Zalaegerszeg, Венгрия, 8900
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Berlin, Германия, 10115
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Dresden, Германия, 01307
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Erlangen, Германия, 91054
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Frankfurt, Германия, 60596
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Leipzig, Германия, D-04103
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Mainz, Германия, D-55116
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Bangalore, Индия, 560010
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Mumbai, Индия, 400 007
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Pune, Индия, 411005
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Catania, Италия, 95100
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Genova, Италия, 16132
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Milano, Италия, 20132
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Pisa, Италия, 56100
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Rome, Италия, 00168
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Mexico City, Мексика, 06700
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Monterrey, Мексика, 64410
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Katowice, Польша, 40-044
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Lublin, Польша, 20-954
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Olesnica, Польша
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Coimbra, Португалия, 3000-076
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Lisbon, Португалия, 1250-203
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Manatí, Пуэрто-Рико, 00674
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San Juan, Пуэрто-Рико, 00907
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Yabucoa, Пуэрто-Рико, 00767
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California
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Sacramento, California, Соединенные Штаты, 95825
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Santa Ana, California, Соединенные Штаты, 92705
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Jacksonville, Florida, Соединенные Штаты, 32204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Miami, Florida, Соединенные Штаты, 33156
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Louisiana
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Baton Rouge, Louisiana, Соединенные Штаты, 70808
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Jersey
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Hamilton, New Jersey, Соединенные Штаты, 08610
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Greenville, South Carolina, Соединенные Штаты, 29605
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Utah
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Ogden, Utah, Соединенные Штаты, 84403
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Virginia
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Charleston, West Virginia, Соединенные Штаты, 25304
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Changhua, Тайвань, 500
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Neihu Taipei, Тайвань, 114
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Yungkang City, Тайвань, 710
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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
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Type 2 diabetes
- Non smoker
- Normal lung function
Exclusion Criteria:
- Pulmonary, hepatic, or renal disease
- Congestive heart failure
- Active malignancy
- Systemic glucocorticoid therapy
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: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 1
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patient specific dose, inhaled, before meals, 24 months
Другие имена:
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Активный компаратор: 2
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patient specific dose, injectable, before meals, 24 months
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
Временное ограничение: 6 months
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6 months
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
Временное ограничение: 24 months
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24 months
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To compare inhaled human insulin to injectable insulin over time with respect to change on body weight
Временное ограничение: baseline and every visit
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baseline and every visit
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To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction
Временное ограничение: baseline, 6 months, 12 months, 18 months, 24 months
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baseline, 6 months, 12 months, 18 months, 24 months
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To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c
Временное ограничение: baseline and every visit
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baseline and every visit
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To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia
Временное ограничение: throughout the study
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throughout the study
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To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements
Временное ограничение: 24 months
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24 months
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To test dose titration methods
Временное ограничение: 6 months
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6 months
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To assess inhaler reliability
Временное ограничение: throughout the study
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throughout the study
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To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients
Временное ограничение: 3 months, 6 months
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3 months, 6 months
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Полезные ссылки
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
1 апреля 2006 г.
Первичное завершение (Действительный)
1 мая 2008 г.
Завершение исследования (Действительный)
1 мая 2008 г.
Даты регистрации исследования
Первый отправленный
10 мая 2006 г.
Впервые представлено, что соответствует критериям контроля качества
10 мая 2006 г.
Первый опубликованный (Оценивать)
12 мая 2006 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
16 сентября 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
6 сентября 2019 г.
Последняя проверка
1 сентября 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 9626
- H7U-MC-IDAU (Другой идентификатор: Eli Lilly and Company)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Сроки обмена IPD
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
Критерии совместного доступа к IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- КСО
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. .