Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day (SeLan)
A Comparative Study to Evaluate the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 DM Patients Uncontrolled With a Basal Insulin or Premix Once a Day
Primary Objective:
To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen
研究概览
详细说明
The study duration for each patient is 24 weeks +/- 1 week broken down as follows:
- Run-in phase: 8 weeks
- Follow - up Period: 16 weeks
The maximal possible time window during the study is +/- one week throughout the study.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Beer Sheva、以色列
- Investigational Site Number 376003
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Haifa、以色列
- Investigational Site Number 376007
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Kfar Saba、以色列、44281
- Investigational Site Number 376004
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Lod、以色列
- Investigational Site Number 376012
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Nazareth、以色列
- Investigational Site Number 376013
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Netanya、以色列
- Investigational Site Number 376006
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Ramat-Gan、以色列
- Investigational Site Number 376001
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Sachnin、以色列
- Investigational Site Number 376009
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Tel Aviv、以色列
- Investigational Site Number 376008
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Tel-Aviv、以色列
- Investigational Site Number 376010
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Tel-aviv、以色列
- Investigational Site Number 376011
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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:
Run-in period:
- Type 2 diabetes
- HbA1c≥ 8.5% (in a test of the last month)
- Age above 21 years
- Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months
- Signed informed consent form
- Patients who according to their physician are eligible to the study
Randomization:
- HbA1c > 7.5%
- FPG < 130 mg/dl
Exclusion criteria:
- Type 1 diabetes
- Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.
- Pregnant or breastfeeding women.
- Patients with allergy to insulin.
- Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.
- Patients with mobility difficulties and/or difficulties communicating with the investigator
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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: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:Arm A: Without Continous Glucose Monitoring (CGM) sensor
Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician |
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
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实验性的:Arm B: Continous Glucose Monitoring (CGM) sensor
Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring. |
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Changes in Hemoglobin A1c (HbA1c) level
大体时间:Baseline, week 24
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Baseline, week 24
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次要结果测量
结果测量 |
大体时间 |
---|---|
Rate of hypoglycemia
大体时间:Week 24
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Week 24
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Changes in insulin glargine dose
大体时间:Baseline, week 24
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Baseline, week 24
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Changes in insulin glulisine dose
大体时间:Baseline, week 24
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Baseline, week 24
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.
INSULIN GLARGINE (HOE901)的临床试验
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