NCT01838083已完成1 期
A Double-blind, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two New Insulin Glargine Formulations Using the Euglycemic Clamp Technique in Subjects With Type 1 Diabetes Mellitus
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
- 50
- 试验地点
- 1
- 主要终点
- Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6
研究概览
简要总结
Primary Objective:
To demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses
Secondary Objective:
- To assess relative Pharmacodynamic activity of the insulin glargine test formulation T to the insulin glargine reference formulation R in steady state conditions after 6 once-daily SC doses
- To assess the safety and tolerability of the test and reference formulations of two new insulin glargine formulations
详细描述
Total study duration per subject: 29 to 64 days including screening visit
Duration of each part of the study for one subject:
- Screening: 3 to 21 days before 1st dosing (Day -21 to Day -3)
- Treatment Period 1 and 2: 8 days (dosing on 6 days)
- Washout between last/1st dosing days of the treatment periods: 7-21 days (preferentially 7 days) End-of-Study Visit: 7-10 days after 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 64 Years（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 formulation (test T formulation)
Experimental
Once daily for 6 days
干预措施: Insulin glargine new formulation HOE901 (Drug)
Insulin glargine new formulation (reference R formulation)
Experimental
Once daily for 6 days
干预措施: Insulin glargine new formulation HOE901 (Drug)
结局指标
主要结局
Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6
时间窗: 24-hours (D6 to D7)
次要结局
- Maximum insulin concentration (INS-Cmax)(24-hours (D6 to D7))
- Time to INS-Cmax (INS-tmax)(24-hours (D6 to D7))
- Time to reach 50% of INS-AUC0-24 (T50%-INS-AUC0-24)(24-hours (D6 to D7))
- Area under the body-weight-standardized Glucose Infusion Rate (GIR) within 24 hours (GIR-AUC0-24h) after dosing on Day 6 during the clamp(24-hours (D6 to D7))
- Maximum smoothed body weight standardized glucose infusion rate (GIRmax)(24-hours (D6 to D7))
- Time to GIRmax (GIR-Tmax)(24-hours (D6 to D7))
- Time to reach at least 50% of GIR-AUC0-24 (T50%-GIR-AUC0-24)(24-hours (D6 to D7))
- Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different prespecified blood glucose levels)(24-hours (D6 to D7))
- Safety as measured by adverse events/serious adverse events, ohypoglycemia events, physical examinations, clinical laboratory, electrocardiograms, vital signs, injection site reactions and anti-insulin antibodies.(up to 9 weeks)
研究者
研究点 (1)
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