Efficacy and Safety of Weight-Based Insulin Titration Regimen in Hospitalized Patients With Type 2 Diabetes (WEB-IT)
Efficacy and Safety of Weight-Based Insulin Titration (WEB-IT) Regimen Compared With Glucose Level-based Regimen in Hospitalized Patients With Type 2 Diabetes: A Randomized Controlled Study
研究概览
详细说明
Patients with type 2 diabetes are randomly assigned by computer-generated block randomization to receive either weight-based or glucose level-based titration regimen. All antidiabetic drugs are discontinued on admission.
Starting dose:
Total daily insulin is 0.4U/kg. Half is given as glargine and the remainder as aspart which is divided into three equal parts used for three pre-meal boluses.
Titration:
Weight-based insulin titration regimen:
Glargine titration: 0.1U/kg per day when fasting blood glucose (FBG) is over 8.0 mmol/L.
Aspart titration: total dose 0.1U/kg per day when next pre-meal blood glucose (BG) is over 8.0 mmol/L, which is divided into three equal parts adding to three pre-meal boluses.
- Glucose level- based titration regimen:
Glargine titration: 4, 6, or 8 U when FBG is, respectively, within the following ranges: 8.0-8.9, 9.0-9.9, >10.0 mmol/L.
Aspart titration: 1, 3, 5, 7 or 8 U when next pre-meal BG is, respectively, within the following ranges: 8.0-10.9, 11.0-13.9, 14.0-16.9, 17.0-19.9, > 20 mmol/L.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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-
Guangdong
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Guangzhou、Guangdong、中国
- 招聘中
- The Second Affiliated Hospital of Guangzhou Medical University
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接触：
- Wangen Li
- 电话号码：86-20-34152032
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients aged 18 to 80 years with type 2 diabetes admitted to Endocrinology wards.
Exclusion Criteria:
- Patients with hepatic or renal dysfunction, cancer, or diabetic ketoacidosis;
- Patients who are pregnant or lactating.
学习计划
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Weight-based
Weight-based insulin insulin titration regimen
|
Glargine titration: 0.1U/kg per day when FBG is over 8.0 mmol/L.
Aspart titration: total dose 0.1U/kg per day when next pre-meal BG is over 8.0 mmol/L, which is divided into three equal parts adding to three pre-meal boluses
|
|
安慰剂比较：Glucose level-based
Glucose level-based insulin titration regimen
|
Glargine titration: 4, 6, or 8 U when FBG is, respectively, within the following ranges: 8.0-8.9, 9.0-9.9, >10.0 mmol/L. Aspart titration: 1, 3, 5, 7 or 8 U when next pre-meal BG is, respectively, within the following ranges: 8.0-10.9, 11.0-13.9, 14.0-16.9, 17.0-19.9, > 20 mmol/L. |
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 |
|---|---|---|
|
Duration
大体时间：at discharge, an average of 9 days
|
Duration to achieve BG targets, including three pre-meal BG and bedtime BG
|
at discharge, an average of 9 days
|
|
Doses
大体时间：at discharge, an average of 9 days
|
Doses of insulin glargine and insulin aspart when the BG targets are achieved
|
at discharge, an average of 9 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hypoglycemia
大体时间：at discharge, an average of 9 days
|
Incidence of hypoglycemia
|
at discharge, an average of 9 days
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse effects
大体时间：at discharge, an average of 9 days
|
Other adverse effects except hypoglycemia
|
at discharge, an average of 9 days
|
合作者和调查者
调查人员
- 首席研究员：Wangen Li, MD、Second Affiliated Hospital of Guangzhou Medical University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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