A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus (CLASSIC)
6 марта 2020 г. обновлено: Eli Lilly and Company
Comparison Between Basal Insulin Analog and Insulin Analog Mid Mixture AS Starter Insulin for Chinese Patients With Type 2 Diabetes Mellitus (CLASSIC Study)
The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
814
Фаза
- Фаза 4
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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Beijing, Китай, 102206
- Peking University International Hospital
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Beijing, Китай
- Beijing Hai Dian Hospital
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Shanghai, Китай, 200090
- Shanghai Yangpu District Central Hospital
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Beijing
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Beijing, Beijing, Китай, 100044
- Peking University Peoples Hospital
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Beijing, Beijing, Китай, 100016
- Beijing Huaxin Hospital
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Chaoyang, Beijing, Китай, 100028
- China Meitan General Hospital
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Fangshan, Beijing, Китай, 102500
- Beijing Yanhua Hospital
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Gansu
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Lanzhou, Gansu, Китай, 730030
- The 2nd Hospital of Lanzhou University
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Guangdong
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Shenzhen, Guangdong, Китай, 518020
- Shenzhen City People Hospital
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Yuexiu, Guangdong, Китай, 510080
- The 1st Hospital with Guangdong Pharmaceutical University
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Henan
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Luoyang, Henan, Китай, 471003
- The 1st Affiliated Hospital of Henan Science and technology
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Zhengzhou, Henan, Китай, 450003
- People's Hospital of Henan Province
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Hubei
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Wuhan, Hubei, Китай, 430022
- Wuhan Union (Xiehe) Hospital
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Jiangsu
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Changzhou, Jiangsu, Китай, 213003
- Changzhou No.2 People's Hospital
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Nanjing, Jiangsu, Китай, 210001
- Nanjing TCM hospital
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Nanjing, Jiangsu, Китай, 210024
- Jiang Su Province Official Hospital
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Nanjing, Jiangsu, Китай, 210048
- Nanjing Jiangbei Hospital
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Nanjing, Jiangsu, Китай, 211100
- Nanjing Jiangning Hospital
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Taizhou, Jiangsu, Китай, 225300
- Taizhou City People Hospital
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Wuxi, Jiangsu, Китай, 214000
- The Second People's Hospital of Wuxi
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Xuzhou, Jiangsu, Китай, 221009
- Xuzhou Central Hospital
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Shandong
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Qingdao, Shandong, Китай, 266071
- Qingdao Municipal Hospital
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Taian, Shandong, Китай, 271000
- Taian City Central Hospital
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Shanghai
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Shanghai, Shanghai, Китай, 200135
- Shanghai Pudong New Area Gongli Hospital
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Shanghai, Shanghai, Китай, 201318
- Shanghai Pudong New District Zhoupu Hospital
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Shunqing
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Nanchong, Shunqing, Китай, 637000
- Affiliated Hospital of North Sichuan Medical College
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Sichuan
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Chengdu, Sichuan, Китай, 610041
- The Third Affiliated Hospital of Chengdu University of TCM
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Luzhou, Sichuan, Китай, 646000
- Southwest Medical University Affiliated Hospital
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Tianjin
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Nankai, Tianjin, Китай, 300192
- Tianjin First Central Hospital
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Tongzhou
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Beijing, Tongzhou, Китай, 101149
- Beijing Luhe Hospital Capital Medical University
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Zhejiang
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Hangzhou, Zhejiang, Китай, 310014
- Zhejiang Provincial People's Hospital
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Ningbo, Zhejiang, Китай, 315010
- Ningbo First Hospital
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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
От 18 лет до 80 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- have type 2 diabetes as defined by World Health Organization (WHO) criteria
- are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator
- most recent HbA1c value ≥7.5% within 12 weeks of study entry
- in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment
- willing to start with insulin treatment
Exclusion Criteria:
- have a diagnosis of type 1 diabetes
- have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time)
- have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study
- are pregnant or breastfeeding, or intend to become pregnant during the course of the study
- are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible
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: Insulin Analog Mid Mixture
Insulin analog mid mixture given subcutaneously (SC).
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Administered SC
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Экспериментальный: Basal Insulin Analog
Basal insulin analog given SC.
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Administered SC
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Временное ограничение: Baseline, 24 Weeks
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HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate. |
Baseline, 24 Weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change From Baseline to Week 48 in HbA1c
Временное ограничение: Baseline, 48 Weeks
|
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate. |
Baseline, 48 Weeks
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Percentage of Participants Who Achieve HbA1c <7% at Week 24
Временное ограничение: 24 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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24 Weeks
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Percentage of Participants Who Achieve HbA1c <7% at Week 48
Временное ограничение: 48 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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48 Weeks
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Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
Временное ограничение: Baseline, 24 Weeks
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Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast.
Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
Временное ограничение: Baseline, 48 Weeks
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Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast.
Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
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Baseline, 48 Weeks
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Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Временное ограничение: Baseline, 24 Weeks
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Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG.
LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Временное ограничение: Baseline, 48 Weeks
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Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG.
LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
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Baseline, 48 Weeks
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Total Daily Insulin Dose at Week 24 and 48
Временное ограничение: 24 Weeks, 48 Weeks
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Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.
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24 Weeks, 48 Weeks
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Change From Baseline to Week 24 in Body Weight
Временное ограничение: Baseline, 24 Weeks
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LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Body Weight
Временное ограничение: Baseline, 48 Weeks
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LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
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Baseline, 48 Weeks
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Rate of Hypoglycemia at Week 24 and 48
Временное ограничение: 24 Weeks, 48 Weeks
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Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L).
The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25)
as an offset variable.
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24 Weeks, 48 Weeks
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Number of Participants With Insulin Treatment Change at Week 48
Временное ограничение: Baseline through 48 Weeks
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Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.
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Baseline through 48 Weeks
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Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
Временное ограничение: 24 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
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24 Weeks
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Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
Временное ограничение: 48 Weeks
|
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
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48 Weeks
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Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
Временное ограничение: Baseline, 48 Weeks
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The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy.
The SEITQ consists of 5 items (that is, statements).
The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications.
Each item score ranges from 1 (strongly disagree) to 7 (strongly agree).
The total SEITQ score is the sum of each item scores, with the range of 5 to 35.
Higher SEITQ score indicates better outcome (higher self-efficacy).
LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.
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Baseline, 48 Weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
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)
6 февраля 2017 г.
Первичное завершение (Действительный)
19 февраля 2019 г.
Завершение исследования (Действительный)
12 июля 2019 г.
Даты регистрации исследования
Первый отправленный
11 января 2017 г.
Впервые представлено, что соответствует критериям контроля качества
11 января 2017 г.
Первый опубликованный (Оценивать)
12 января 2017 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
18 марта 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
6 марта 2020 г.
Последняя проверка
15 августа 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 16507
- F3Z-GH-IOQR (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
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
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. .