NCT01127269已完成4 期
Practical Implementation of ADA/EASD Consensus Algorithm in Patients With Type 2 Diabetes: Timely Insulin Initiation and Titration
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
- 178
- 试验地点
- 23
- 主要终点
- Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no severe documented nocturnal hypoglycemia episode.
研究概览
简要总结
Primary Objective:
Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) < 7% with no severe or nocturnal hypoglycemic episodes at 6 months
Secondary Objectives:
- Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months
- Insulin glargine dose at 3 and 6 months
- Hypoglycemic episodes (all types)
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
- 21 Years 至 80 Years（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
Experimental
Patients will receive insulin glargine titrated based on standard of care as recommended by the ADA/EASD Consensus Algorithm. Step 1: insulin glargine initiation regimen for insulin naive patients/ Switch to insulin glargine for patient already treated with basal insulin.
Step 2: the insulin dosage of patients will be titrated according to the ADA/EASD Consensus Algorithm.
干预措施: INSULIN GLARGINE (Drug)
结局指标
主要结局
Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no severe documented nocturnal hypoglycemia episode.
时间窗: From week 0 (baseline) to week 24 (end of study)
次要结局
- Glycosylated Haemoglobin (HbA1c)(From week 0 (baseline) to week 24 (end of study))
- Dose and timing of insulin glargine(From week 0 (baseline) to week 24 (end of study))
- Hypoglycemic episodes(From week 0 (baseline) to week 24 (end of study))
研究者
研究点 (23)
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