Exenatide and Impaired Hypoglycaemic Awareness in Type 1 Diabetes
2018年4月11日 更新者：Radboud University Medical Center
Effect of the GLP-1 Receptor Agonist Exenatide on Impaired Hypoglycaemic Awareness in Type 1 Diabetes
Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect hypoglycaemia, a condition referred to as impaired hypoglycaemic awareness (IHA) that causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia.
IHA is usually the end-result of a process of habituation to recurrent hypoglycemia that is potentially reversible.
Treatment with glucagon-like peptide (GLP)-1 Receptor Agonists (1RAs) in addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1 diabetes.
This study will test the hypothesis that treatment with the GLP-1RA, exenatide, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with type 1 diabetes and IHA.
In a randomized doubleblind placebo-controlled cross-over trial, patients will be treated for 6 weeks with exenatide (or placebo), after which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic hypoglycemic glucose clamp study.
研究概览
研究类型
介入性
注册 (实际的)
10
阶段
- 阶段2
- 第三阶段
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
-
-
-
Nijmegen、荷兰
- Radboud university medical centre
-
-
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 70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:
- Type 1 diabetes, disease duration >1 year
- Age >18 years, <70 years
- Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
- Impaired hypoglycaemic awareness as assessed by a score of 3 or more on the modified Dutch translation of the Clarke questionnaire
- Glycated haemoglobin (HbA1c) ≥42 mmol/mol (6%) and ≤75 mmol/mol (9.0%)
- Ability to provide informed consent
Exclusion Criteria:
- Treatment with incretin-based therapy
- Known intolerance to GLP-1RAs (including allergy)
- Treatment with glucose-modifying or immune-modifying agents, e.g. prednisolon
- Recent history of myocardial infarction or stroke (past year) or laser coagulation for proliferative retinopathy (past 6 months)
- Proliferative retinopathy
- Symptomatic diabetic neuropathy
- Diabetic nephropathy as reflected by albumin-creatinin ratio >30 mmol/mg or estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73 m2
- Known heart failure
- History of pancreatitis (acute or chronic) or pancreatic cancer
- Body-mass index >40 kg/m2
- Use of premixed insulin or of long-acting insulin alone
- Total daily insulin dose requirements <20 units unless on pump treatment
- Pregnancy or unwillingness to undertake measures for birth control
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：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：EXENATIDE
Exenatide
|
6 weeks treatment with exenatide on top of insulin treatment
其他名称：
|
|
安慰剂比较：PLACEBO
Placebo matched to exenatide
|
6 weeks treatment with placebo on top of insulin treatment
|
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 |
|---|---|---|
|
Symptom score in response to insulin-induced hypoglycaemia
大体时间：30 minutes
|
Measured during hyperinsulinemic hypoglycaemic glucose clamps
|
30 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adrenaline response to insulin-induced hypoglycaemia
大体时间：30 minutes
|
Measured in plasma during hyperinsulinemic hypoglycaemic glucose clamps
|
30 minutes
|
|
Glucagon response to insulin-induced hypoglycaemia
大体时间：30 minutes
|
Measured in plasma during hyperinsulinemic hypoglycaemic glucose clamps
|
30 minutes
|
|
Time until glycaemic recovery from hypoglycaemia
大体时间：1 hour
|
Measured during hyperinsulinemic hypoglycaemic glucose clamps
|
1 hour
|
|
Maximal glucose excursion post-hypoglycaemia
大体时间：1 hour
|
Measured during hyperinsulinemic hypoglycaemic glucose clamps
|
1 hour
|
|
Time until glucose peak post-hypoglycaemia
大体时间：1 hour
|
Measured after hyperinsulinemic hypoglycaemic glucose clamps
|
1 hour
|
|
Area under the glucose concentration curve post-hypoglycaemia
大体时间：1 hour
|
Measured after hyperinsulinemic hypoglycaemic glucose clamps
|
1 hour
|
|
Hunger score post-hypoglycaemia
大体时间：1 hour
|
Measured after hyperinsulinemic hypoglycaemic glucose clamps
|
1 hour
|
|
Carbohydrate requirement after recovery from hypoglycaemia
大体时间：1 hour
|
Measured after hyperinsulinemic hypoglycaemic glucose clamps by showing pictures of various carbohydrate-containing snacks and beverages
|
1 hour
|
|
Number of severe hypoglycaemic events during follow-up
大体时间：16 weeks
|
16 weeks
|
|
|
Number of nocturnal hypoglycaemic events during follow-up
大体时间：16 weeks
|
16 weeks
|
|
|
Number of any hypoglycaemic events during follow-up
大体时间：16 weeks
|
16 weeks
|
|
|
Number of hypoglycaemic events measured by glucose sensor monitoring
大体时间：1 week
|
optional (in participants agreeing to wear a continuous glucose sensor for 5 days)
|
1 week
|
|
Time spent under hypoglycaemic conditions measured by glucose sensor monitoring
大体时间：1 week
|
optional (in participants agreeing to wear a continuous glucose sensor for 5 days)
|
1 week
|
|
Glucose variability as measured by glucose sensor monitoring
大体时间：1 week
|
optional (in participants agreeing to wear a continuous glucose sensor for 5 days)
|
1 week
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pulse rate
大体时间：6 weeks
|
Measured during hyperinsulinemic hypoglycaemic glucose clamps
|
6 weeks
|
|
Gastrointestinal side effects
大体时间：16 weeks
|
16 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。
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21日
初级完成 (实际的)
2018年3月28日
研究完成 (实际的)
2018年4月9日
研究注册日期
首次提交
2016年2月22日
首先提交符合 QC 标准的
2016年4月6日
首次发布 (估计)
2016年4月12日
研究记录更新
最后更新发布 (实际的)
2018年4月12日
上次提交的符合 QC 标准的更新
2018年4月11日
最后验证
2017年4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.