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A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus (CLASSIC)

2020年3月6日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

814

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、102206
        • Peking University International Hospital
      • Beijing、中国
        • Beijing Hai Dian Hospital
      • Shanghai、中国、200090
        • Shanghai Yangpu District Central Hospital
    • Beijing
      • Beijing、Beijing、中国、100044
        • Peking University Peoples Hospital
      • Beijing、Beijing、中国、100016
        • Beijing Huaxin Hospital
      • Chaoyang、Beijing、中国、100028
        • China Meitan General Hospital
      • Fangshan、Beijing、中国、102500
        • Beijing Yanhua Hospital
    • Gansu
      • Lanzhou、Gansu、中国、730030
        • The 2nd Hospital of Lanzhou University
    • Guangdong
      • Shenzhen、Guangdong、中国、518020
        • Shenzhen City People Hospital
      • Yuexiu、Guangdong、中国、510080
        • The 1st Hospital with Guangdong Pharmaceutical University
    • Henan
      • Luoyang、Henan、中国、471003
        • The 1st Affiliated Hospital of Henan Science and technology
      • Zhengzhou、Henan、中国、450003
        • People's Hospital of Henan Province
    • Hubei
      • Wuhan、Hubei、中国、430022
        • Wuhan Union (Xiehe) Hospital
    • Jiangsu
      • Changzhou、Jiangsu、中国、213003
        • Changzhou No.2 People's Hospital
      • Nanjing、Jiangsu、中国、210001
        • Nanjing TCM hospital
      • Nanjing、Jiangsu、中国、210024
        • Jiang Su Province Official Hospital
      • Nanjing、Jiangsu、中国、210048
        • Nanjing Jiangbei Hospital
      • Nanjing、Jiangsu、中国、211100
        • Nanjing Jiangning Hospital
      • Taizhou、Jiangsu、中国、225300
        • Taizhou City People Hospital
      • Wuxi、Jiangsu、中国、214000
        • The Second People's Hospital of Wuxi
      • Xuzhou、Jiangsu、中国、221009
        • Xuzhou Central Hospital
    • Shandong
      • Qingdao、Shandong、中国、266071
        • Qingdao Municipal Hospital
      • Taian、Shandong、中国、271000
        • Taian City Central Hospital
    • Shanghai
      • Shanghai、Shanghai、中国、200135
        • Shanghai Pudong New Area Gongli Hospital
      • Shanghai、Shanghai、中国、201318
        • Shanghai Pudong New District Zhoupu Hospital
    • Shunqing
      • Nanchong、Shunqing、中国、637000
        • Affiliated Hospital of North Sichuan Medical College
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • The Third Affiliated Hospital of Chengdu University of TCM
      • Luzhou、Sichuan、中国、646000
        • Southwest Medical University Affiliated Hospital
    • Tianjin
      • Nankai、Tianjin、中国、300192
        • Tianjin First Central Hospital
    • Tongzhou
      • Beijing、Tongzhou、中国、101149
        • Beijing Luhe Hospital Capital Medical University
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310014
        • Zhejiang Provincial People's Hospital
      • Ningbo、Zhejiang、中国、315010
        • Ningbo First Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Insulin Analog Mid Mixture
Insulin analog mid mixture given subcutaneously (SC).
药品：Insulin Analog Mid Mixture
Administered SC
实验性的：Basal Insulin Analog
Basal insulin analog given SC.
药品：Basal Insulin Analog
Administered SC

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
大体时间：Baseline, 24 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 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

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline to Week 48 in HbA1c
大体时间：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
Percentage of Participants Who Achieve HbA1c <7% at Week 24
大体时间：24 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.
24 Weeks
Percentage of Participants Who Achieve HbA1c <7% at Week 48
大体时间：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.
48 Weeks
Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
大体时间：Baseline, 24 Weeks
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.
Baseline, 24 Weeks
Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
大体时间：Baseline, 48 Weeks
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.
Baseline, 48 Weeks
Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
大体时间：Baseline, 24 Weeks
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.
Baseline, 24 Weeks
Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
大体时间：Baseline, 48 Weeks
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.
Baseline, 48 Weeks
Total Daily Insulin Dose at Week 24 and 48
大体时间：24 Weeks, 48 Weeks
Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.
24 Weeks, 48 Weeks
Change From Baseline to Week 24 in Body Weight
大体时间：Baseline, 24 Weeks
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.
Baseline, 24 Weeks
Change From Baseline to Week 48 in Body Weight
大体时间：Baseline, 48 Weeks
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.
Baseline, 48 Weeks
Rate of Hypoglycemia at Week 24 and 48
大体时间：24 Weeks, 48 Weeks
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.
24 Weeks, 48 Weeks
Number of Participants With Insulin Treatment Change at Week 48
大体时间：Baseline through 48 Weeks

Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.

  1. Discontinuation: Defined as stopping insulin treatment for 30 days or more.
  2. Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class.
  3. Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group
  4. Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD.
Baseline through 48 Weeks
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
大体时间：24 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.
24 Weeks
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
大体时间：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.
48 Weeks
Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
大体时间：Baseline, 48 Weeks
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.
Baseline, 48 Weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年2月6日

初级完成 (实际的)

2019年2月19日

研究完成 (实际的)

2019年7月12日

研究注册日期

首次提交

2017年1月11日

首先提交符合 QC 标准的

2017年1月11日

首次发布 (估计)

2017年1月12日

研究记录更新

最后更新发布 (实际的)

2020年3月18日

上次提交的符合 QC 标准的更新

2020年3月6日

最后验证

2019年8月15日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 16507
  • F3Z-GH-IOQR (其他标识符：Eli Lilly and Company)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

IPD 共享时间框架

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.

IPD 共享访问标准

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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罕见疾病

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