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赛诺菲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) IV期 219
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临床试验NCT01234597 (SeLan)旨在研究治疗，主要针对2型糖尿病。这是一项IV期 干预性研究试验，试验状态为已完成。试验开始于2012年12月1日，共计划招募219名患者。该研究由赛诺菲主导，已于2015年4月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2016年7月13日。
简要概括
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
详细描述
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.
官方标题
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
疾病
2型糖尿病其他研究标识符
- SeLan
- LANTU_L_05146
- U1111-1116-2926 (其他标识符) (UTN)
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照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 | INSULIN GLARGINE (HOE901) Pharmaceutical form: solution for injection Route of administration: subcutaneous INSULIN GLULISINE (HMR1964) Pharmaceutical form:Solution for injection Route of administration: Subcutaneous |
实验性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...显示更多 | INSULIN GLARGINE (HOE901) Pharmaceutical form: solution for injection Route of administration: subcutaneous INSULIN GLULISINE (HMR1964) Pharmaceutical form:Solution for injection Route of administration: Subcutaneous |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Changes in Hemoglobin A1c (HbA1c) level | Baseline, week 24 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Rate of hypoglycemia | Week 24 | |
Changes in insulin glargine dose | Baseline, week 24 | |
Changes in insulin glulisine dose | Baseline, week 24 |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
21 Years
适龄性别
全部
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
- 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.
赛诺菲没有联系数据。
11 位于 1 个国家/地区的研究中心
Investigational Site Number 376003, Beersheba, Israel
Investigational Site Number 376007, Haifa, Israel
Investigational Site Number 376004, Kfar Saba, 44281, Israel
Investigational Site Number 376012, Lod, Israel
Investigational Site Number 376013, Nazareth, Israel
Investigational Site Number 376006, Netanya, Israel
Investigational Site Number 376001, Ramat Gan, Israel
Investigational Site Number 376009, Sakhnin, Israel
Investigational Site Number 376008, Tel Aviv, Israel
Investigational Site Number 376010, Tel Aviv, Israel
Investigational Site Number 376011, Tel Aviv, Israel