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Comparison of Two Titration Programs of Adding Insulin Detemir to OADs in Poorly Controlled Type 2 Diabetes

2018年8月16日 更新者：Sung-Chen Liu、Mackay Memorial Hospital

Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients

This study compared the effectiveness and safety of two treatment algorithms for insulin detemir initiation and titration: active titration algorithm (performed by investigator weekly) versus usual titration algorithm (performed by study subjects weekly) in patients with type 2 diabetes poorly controlled by OADs.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 200 patients with type 2 diabetes in the Taiwan. The effectiveness of insulin detemir will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period.

Inclusion criteria:

Patients must meet all of the following criteria:

  1. Men and women with type 2 diabetes.
  2. 20 years of age.
  3. Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
  4. Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
  5. Patients who are willing and able to cooperate with study and give signed informed consent.

After enrollment, eligible patients will be randomized in a 1:1 ratio to one of the following titration algorithms:

  • Active titration algorithm: contact with investigator by telephone weekly.
  • Usual titration algorithm: contact with investigator only at routine study visit.

研究类型

介入性

注册 (实际的)

181

阶段

  • 不适用

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

  • 台湾
      • Hsinchu、台湾、30067
        • Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
      • Taipei、台湾、10449
        • Mackay Memorial Hospital
      • Taitung、台湾、95054
        • Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch

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

20年 及以上 (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:

Patients must meet all of the following criteria:

  1. Men and women with type 2 diabetes.
  2. 20 years of age.
  3. Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
  4. Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
  5. Patients who are willing and able to cooperate with study and give signed informed consent.

Exclusion Criteria:

  1. Patients with type 1 diabetes.
  2. Renal dialysis patients.
  3. History of hypoglycemia unawareness.
  4. Patients who had received any insulin for more than 2 weeks or who have received insulin treatment within 4 weeks prior to screening visit.
  5. Patients who have received any investigational products (drug and device) within 4 weeks prior to screening visit.
  6. Patients hypersensitive with insulin detemir or its excipients.
  7. Patients who are currently pregnant/lactating,or who are preparing for pregnancy or lactation.

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
有源比较器：Active titration algorithm
titrate insulin dose by contacting with investigator by telephone weekly.
行为的：Active titration algorithm
Patients in active titration algorithm group will contact with investigator by telephone weekly to self-adjust the insulin dose till they achieve the target of FPG(<110mg/dl).
其他名称：
  • Insulin detemir active titration algorithm
实验性的：Usual titration algorithm
contact with investigator only at routine study visit.
行为的：Usual titration algorithm
All patients will be instructed to self-measure fasting capillary blood glucose. The dose of insulin detemir will be adjusted based on the average of three consecutive FPG values. the daily insulin dose should be increased by 2 IU/day if the FPG>=110mg/dL, and by 4 IU/day if the FPG>=180 mg/dL without any intervening hypoglycemic episodes; or it should be decreased by 2 or 4 IU/day if the FPG < 70 mg/dL.
其他名称：
  • Insulin detemir usual titration algorithm

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
To compare the change in HbA1c between two study groups at Week 24.
大体时间：24 weeks
compare the change in HbA1c between two study groups after 24 weeks treatment.
24 weeks

次要结果测量

结果测量
措施说明
大体时间
To compare the change in HbA1C between two study groups at Week 12.
大体时间：12 weeks
compare the change in HbA1C between two study groups after 12 of treatment.
12 weeks
To compare the proportion of patients achieving HbA1C <7% at Week 24
大体时间：24 weeks
compare the proportion of patients achieving HbA1C <7% after 24 weeks treatment
24 weeks
To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.
大体时间：24 weeks
compare the changes in fasting plasma glucose (FPG) after 12 and 24 treatment.
24 weeks
To compare the change in body weight at each visit
大体时间：24 weeks
compare the change in body weight at each visit
24 weeks
To evaluate the incidence of adverse events.
大体时间：24 weeks
evaluate the incidence of adverse events including hypoglycemia and any other adverse event.
24 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

Mackay Memorial Hospital

调查人员

  • 学习椅：Sung-Chen Liu, MD、Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
  • 首席研究员：Hui-Fang Chang, MD、Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
  • 首席研究员：Ke-Yan Wu, MD、Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch

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

2011年1月1日

初级完成 (实际的)

2015年10月1日

研究完成 (实际的)

2016年5月1日

研究注册日期

首次提交

2011年1月20日

首先提交符合 QC 标准的

2011年1月20日

首次发布 (估计)

2011年1月24日

研究记录更新

最后更新发布 (实际的)

2018年8月20日

上次提交的符合 QC 标准的更新

2018年8月16日

最后验证

2016年3月1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

  • 10M MHIS112

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.

2型糖尿病的临床试验

Active titration algorithm的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

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地点

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