NCT02027753已完成4 期
Efficacy and Safety of TrEating Type 2 Diabetic Patients With Inadequate Response to Metformin and DPP-4 Inhibitors by Adding Basal Insulin Therapy (Insulin Glargine)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy
研究概览
简要总结
Primary Objective:
To investigate the efficacy(HbA1c) at 6 months after adding basal insulin therapy (insulin glargine) to dipeptidyl peptidase-IV (DPP-IV) and metformin plus or minus sulphonylurea
Secondary Objectives:
- To assess the efficacy by adding insulin glargine
- To assess insulin dose
- Safety
详细描述
28 weeks (Screening: About 2 weeks/Treatment: 24 weeks (6 months)/Follow-up: 2 weeks)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Insulin glargine and Oral anti diabetic treatment(s)
Experimental
- Insulin glargine: Lantus
- Add basal insulin: starting with 0.2 U/kg/day or 10 U/day
- Adjust insulin glargine dose according to Fasting blood glucose
- Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion.
干预措施: INSULIN GLARGINE (Drug)
Insulin glargine and Oral anti diabetic treatment(s)
Experimental
- Insulin glargine: Lantus
- Add basal insulin: starting with 0.2 U/kg/day or 10 U/day
- Adjust insulin glargine dose according to Fasting blood glucose
- Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion.
干预措施: Metformin (Drug)
Insulin glargine and Oral anti diabetic treatment(s)
Experimental
- Insulin glargine: Lantus
- Add basal insulin: starting with 0.2 U/kg/day or 10 U/day
- Adjust insulin glargine dose according to Fasting blood glucose
- Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion.
干预措施: DPP-4 inhibitor (Drug)
Insulin glargine and Oral anti diabetic treatment(s)
Experimental
- Insulin glargine: Lantus
- Add basal insulin: starting with 0.2 U/kg/day or 10 U/day
- Adjust insulin glargine dose according to Fasting blood glucose
- Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion.
干预措施: Sulphonylurea (Drug)
结局指标
主要结局
Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy
时间窗: week 24 (6 months)
次要结局
- Percentage of patients with HbA1c ≤7%(week 12 (3 months))
- Change from baseline in HbA1c(week 12 (3 months), week 24 (6 months))
- Percentage of patients with HbA1c ≤6.5%(week 12 (3 months), week 24 (6 months))
- Change from baseline in Fasting Plasma glucose (FPG), 2hr-Postprandial Plasma Glucose(week 12 (3 months), week 24 (6 months))
- Total daily insulin dose(week 24 (6 months))
- Fasting blood glucose (FBG) values(During 3 consecutive days before baseline, week 12, Week 24)
- 7-point Self Monitoring of Blood Glucose(During 2 days within 7 days before baseline, week 12, week 24)
- Weight change from baseline(week 24 (6 months))
- Number of Patients with Hypoglycemic Events(up to 6 months)
- Number of Patients with Adverse Events(up to 6 months)
研究者
研究点 (1)
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