A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 243
- 试验地点
- 22
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
Primary Objective:
To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese patients with type 1 diabetes mellitus
Secondary Objectives:
To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.
To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia
详细描述
The duration of study will consist of:
- Up to 2-week screening period;
- 6-month open-label comparative efficacy and safety treatment period;
- 6-month open-label comparative safety extension period;
- 4-week post-treatment safety follow-up period
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
- 18 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
New formulation of insulin glargine
once daily in the evening on-top of mealtime insulin
干预措施: Insulin glargine new formulation (HOE901) (Drug)
Lantus (insulin glargine)
once daily in the evening on-top of mealtime insulin
干预措施: Insulin glargine (HOE901) (Lantus) (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: baseline, 6 months
次要结局
- Change from baseline in daily basal insulin dose(baseline, 6 months)
- Number of Patients with various types of Hypoglycemia Events(up to 6 months)
- Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)(up to 6 months)
- Change from baseline in FPG(baseline, 6 months)
- Change from baseline in pre-basal insulin injection SMPG(baseline, 6 months)
- Change from baseline in 8-point SMPG profiles(baseline, 6 months)
- Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)(baseline, 6 months)
- Change from baseline in variability of plasma glucose profile(baseline, 6 months)