Basal-bolus Insulin Therapy Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study
2017年8月8日 更新者：Merete Bechmann Christensen
Basal-bolus Insulin Therapy With Insulin Degludec and Insulin Aspart Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study
Hyperglycemia during admission is associated with increased rate of complications and longer hospital stays, thus insulin treatment is recommended for all diabetes patients with hyperglycemia.
Inpatient studies of non-critically ill patients show better glycemic control with the use of basal-bolus insulin therapy compared to sliding scale insulin therapy, but increased rates of hypoglycemia.
The investigators hypothesize that basal-bolus insulin therapy with a new ultra-long-action basal insulin can treat hyperglycemia more efficiently than sliding scale insulin, with few episodes of hypoglycemia.
研究概览
详细说明
The aim of this study is to investigate and compare the efficacy and safety of basal-bolus insulin therapy using the insulin analogue, insulin degludec once daily and insulin aspart before meals versus standard therapy with sliding scale insulin in non-critical ill hospitalized patients with type 2 diabetes.
The design of the trial is an open, randomized controlled trial with two parallel arms (treatment arm and control arm). Randomization is 1:1.
研究类型
介入性
注册 (预期的)
100
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
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Hvidovre、丹麦、2650
- 招聘中
- Hvidovre University Hospital
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接触：
- Merete B. Christensen, MD
- 电话号码：+4538623389
- 邮箱：merete.bechmann.christensen.01@regionh.dk
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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 90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:
- History of type 2 diabetes for at least 6 months
- Age 18 - 90 years
- Pre-meal plasma glucose in the range 10 - 22,2 mmol/L prior to inclusion
- Expected hospital stay longer than 4 days
Exclusion Criteria:
- Hyperglycemia without known history of type 2 diabetes
- Type 1 diabetes mellitus
- Severely impaired renal function (eGFR ≤ 30 mL/min/1,73 m2)
- Severe hepatic disease
- Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
- Pregnant or lactating women or fertile female patients not using chemical, hormonal or mechanical contraceptives or not in menopause (i.e. must not have had regular menstrual bleeding for at least one year)
- Planned treatment during hospital stay with intravenous glucose/ insulin for ≥ 12 hours
- Treatment at admission or planned treatment during hospital stay with parenteral nutrition or enteral nutrition (i.e. gastroenteric tube feeding)
- Treatment at admission or planned treatment during hospital stay with high dose glucocorticoids (>40 mg)
- History or presence of malignancy (except basal skin cancer) unless a disease-free period exceeding five years
- Presence of alcohol or drug abuse
- Inability to understand the written information or incapability to provide informed consent
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 |
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有源比较器：Intervention
Basal-bolus insulin regime with Insulin Degludec and insulin aspart
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Basal-bolus insulin regime
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无干预：Standard
Standard treatment according to hospital guidelines with sliding scale insulin
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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 |
|---|---|---|
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Difference in mean daily plasma glucose between the two groups
大体时间：Duration of hospital stay, an expected average of 8 days
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Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient.
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Duration of hospital stay, an expected average of 8 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L)
大体时间：Duration of hospital stay, an expected average of 8 days
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Based on bedside PG measures and on CGM data
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Duration of hospital stay, an expected average of 8 days
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Time spent in glycemic range
大体时间：Duration of hospital stay, an expected average of 8 days
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Based on bedside PG measures and on CGM data
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Duration of hospital stay, an expected average of 8 days
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Time spent in hyperglycemic range
大体时间：Duration of hospital stay, an expected average of 8 days
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Based on bedside PG measures and on CGM data
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Duration of hospital stay, an expected average of 8 days
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Length of hospital stay
大体时间：Duration of hospital stay, an expected average of 8 days
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Mean duration of hospital stay
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Duration of hospital stay, an expected average of 8 days
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Difference in insulin dose between groups
大体时间：Duration of hospital stay, an expected average of 8 days
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Calculated as mean insulin dose during admission
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Duration of hospital stay, an expected average of 8 days
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Number of hospital acquired infections during admission
大体时间：Duration of hospital stay, an expected average of 8 days
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Data from hospital record
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Duration of hospital stay, an expected average of 8 days
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Number of post-discharge infections or re-admissions 1 month after discharge
大体时间：1 month
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Data collected on follow-up 1 month after discharge
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1 month
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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。
合作者
调查人员
- 首席研究员：Kirsten B Norgaard, DMSC、Hvidovre University Hospital
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4月1日
初级完成 (预期的)
2018年4月1日
研究完成 (预期的)
2018年4月1日
研究注册日期
首次提交
2017年6月7日
首先提交符合 QC 标准的
2017年8月8日
首次发布 (实际的)
2017年8月9日
研究记录更新
最后更新发布 (实际的)
2017年8月9日
上次提交的符合 QC 标准的更新
2017年8月8日
最后验证
2017年8月1日
更多信息
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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