NCT01195454已完成1 期
Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36)
研究概览
简要总结
Primary Objective:
- To assess the total metabolic effect ratios of a new insulin glargine formulation versus Lantus®
Secondary Objectives:
- To assess the exposure ratios of a new insulin glargine formulation versus Lantus®
- To compare the duration of action of a new insulin glargine formulation versus Lantus®
- To explore the dose response and dose exposure relationship of a new insulin glargine formulation
- To assess the safety and tolerability of a new insulin glargine formulation
详细描述
The study period for one patient is one month in average and it can last up to 11 weeks broken down as follows:
- Screening: 3 to 28 days
- Treatment period: 1 to 4 days: 2 days (1 overnight stay)
- Washout period: 5 to 18 days (preferentially 7 days between consecutive dosings)
- End of study: 1 day after the last dosing
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 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 / New insulin glargine formulation
Experimental
- Period 1: Insulin glargine
- Period 2: New insulin glargine formulation
- Period 3: New insulin glargine formulation
- Period 4: New insulin glargine formulation
Duration of treatment: 1 day at each period
干预措施: Insulin glargine (HOE901) (Drug)
结局指标
主要结局
The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36)
时间窗: 36 hours (D1 to D2) in all four treatment periods
次要结局
- The area under the insulin glargine concentration curve within 36 hours (INS-AUC0-36) -(36 hours (D1 to D2) in all four treatment periods)
- Time to 50% of the GIR-AUC0-36 (T50%-GIR AUC0-36)(36 hours (D1 to D2) in all four treatment periods)
- Time to 50% of INS-AUC0-36 (T50% INS-AUC0-36)(36 hours (D1 to D2) in all four treatment periods)
- Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)(36 hours (D1 to D2) in all four treatment periods)
- Maximum smoothed body weight standardized glucose infusion rate GIRmax, and time to GIRmax (GIR-Tmax)(36 hours (D1 to D2) in all four treatment periods)
- Maximum insulin concentration INS-Cmax, and time to Cmax (INS-Tmax)(36 hours (D1 to D2) in all four treatment periods)
研究者
研究点 (1)
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