Asian Treat to Target Lantus Study: A Randomized, Multicentre, Multinational, Open-Label, Parallel-Group, 24-Week Phase IV Study Evaluating the Effectiveness and Safety of Physician Versus Patient-led Initiation and Titration of Insulin Glargine in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 555
- 试验地点
- 1
- 主要终点
- Change (decrease) in mean hemoglobin glycosylated (HbA1c) level
研究概览
简要总结
Primary Objective:
To compare patient-led titration (intervention group) versus physician-led titration (usual standard of care) in optimizing the clinical use of insulin glargine in an Asian population of patients with Type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs).
Secondary Objectives:
To determine the difference in glycemic control, safety, quality of life and treatment satisfaction between patient-led titration and usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 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
Intervention group
Initiation on a fixed dose of insulin glargine, then subjects will self-adjusted their basal insulin dose every 3 days
干预措施: Insulin Glargine (Drug)
Usual standard of care group
Initiation on a fixed dose of insulin glargine, then basal insulin dose is adjusted at each visit by a physician
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Change (decrease) in mean hemoglobin glycosylated (HbA1c) level
时间窗: from week 0 (baseline) to week 24 (end of study)
次要结局
- Percentage of patients achieving HbA1c levels < 7.0% without experiencing severe hypoglycemia(from week 0 (baseline) to week 24 (end of study))
- Percentage of patients achieving target HbA1c levels (< 7.0% and <6.5%)(from week 0 (baseline) to week 24 (end of study))
- Number of patients having a drop of 1% in HbA1c levels and/or a drop of at least 0.5%.(from week 0 (baseline) to week 24 (end of study))
- Mean change in Fasting Plasma glucose (FPG) and Post Prandial blood Glucose (PPG)(from week 0 (baseline) to week 24 (end of study))
- Evolution of Blood Glucose profiles(from week 0 (baseline) to week 24 (end of study))
- Incidence of symptomatic hypoglycemia(from week 0 (baseline) to week 24 (end of study))
- Incidence of nocturnal hypoglycemia(from week 0 (baseline) to week 24 (end of study))
- Incidence of asymptomatic hypoglycemia(from week 0 (baseline) to week 24 (end of study))
- Mean change in body weight in patients(from week 0 (baseline) to week 24 (end of study))
- Mean insulin dose(from week 0 (baseline) to week 24 (end of study))
- PROMs (patient reported outcome measures) scores from the DTSQs/c (diabetes treatment satisfaction questionnaire status) and EQ-5D (European quality of life - 5 dimensions)(from week 0 (baseline) to week 24 (end of study))