A Single-Center, Randomized, Double-Blind, 3-Treatment, 3-Period, 6-Sequence Cross-Over Study To Compare The Pharmacokinetic And Pharmacodynamic Effects of Single Doses of Insulin Glargine Given As U200 And U500 To Lantus® In A Euglycemic Clamp Setting In Subjects With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Area under the serum insulin glargine (INS) concentration curve over the first 12 hours after dosing
研究概览
简要总结
Primary Objective:
To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.
Secondary Objectives:
To compare the metabolic activity characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.
To assess the safety and tolerability of single doses of U200, U500 and Lantus® U100 in subjects with type 1 diabetes.
详细描述
Total study duration for each subject is between 3.5 and 12 weeks.
Two overnight stays at the unit in each of 3 treatment periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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 U100
1 single dose
干预措施: insulin glargine U100 HOE901 (Drug)
insulin glargine U200
1 single dose
干预措施: insulin glargine U200 HOE901 (Drug)
insulin glargine U500
1 single dose
干预措施: insulin glargine U500 HOE901 (Drug)
结局指标
主要结局
Area under the serum insulin glargine (INS) concentration curve over the first 12 hours after dosing
时间窗: 12 hours
次要结局
- INS-Area Under the Curve (AUC) over 24 and 36 hours after dosing (INS AUC 0-24 and INS AUC 0-36)(36 hours)
- AUC up to the last measurable concentration(36 hours)
- Time to reach 50% of INS-AUC 0-36(36 hours)
- Time to reach INS-Cmax (INS-tmax)(36 hours)
- Area under the body-weight-standardized Glucose Infusion Rate (GIR) over the first 12, 24 and 36 hours after dosing (GIR-AUC0-12, GIR-AUC0-24 and, GIR-AUC0-36)(36 hours)
- Time to reach 50% of GIR-AUC0-36 (T50%-GIR-AUC0-36)(36 hours)
- Maximum smoothed body weight standardized glucose infusion rate (GIRmax) and time to GIRmax (GIR-Tmax)(36 hours)
- Duration of blood glucose control (time to elevation of smoothed blood glucose profile above different pre-specific blood glucose levels)(4 days)
- Safety and tolerability (Number of patients with adverse events, clinically significant changes in vital signs, laboratory parameters)(4 days)