A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in 24-hour blood glucose profile measured by continuous glucose monitoring
研究概览
简要总结
Primary Objective:
- To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state
Secondary Objectives:
- To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;
- To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));
- To compare the occurrence of hypoglycemia between the 2 treatments;
- To assess the safety and tolerability of a new formulation of insulin glargine.
详细描述
66 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
Sequence 1
Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
干预措施: insulin glargine (HOE901) (Drug)
Sequence 1
Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
干预措施: insulin glargine- new formulation (HOE901) (Drug)
Sequence 2
Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
干预措施: insulin glargine (HOE901) (Drug)
Sequence 2
Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
干预措施: insulin glargine- new formulation (HOE901) (Drug)
结局指标
主要结局
Change in 24-hour blood glucose profile measured by continuous glucose monitoring
时间窗: Baseline, Day 28, Day 56
次要结局
- Hypoglycemia categorized by the definition of American Diabetes Association(Up to Day 56)
- Change in fasting plasma glucose from baseline to each treatment end by treatment(Baseline, Day 28, Day 56)
- Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment(Baseline, Day 28, Day 56)
- Change in HbA1c from baseline to each treatment end by treatment(Baseline, Day 28, Day 56)