NCT00310297已完成1 期
A Randomized, Open Label, Two-arm, Cross-over Design Study to Compare the Pharmacodynamics and Pharmacokinetics of Insulin Glulisine and Insulin Lispro in Obese Patients With Type 2 Diabetes.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 主要终点
- Time to GLUmax (Tmax, min)
研究概览
简要总结
Primary objective:
To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes.
Secondary objectives:
- To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day.
- The safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.
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
- 18 Years 至 75 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
结局指标
主要结局
Time to GLUmax (Tmax, min)
时间窗: during the study conduct
Maximum plasma glucose concentration (GLUmax, mmol/L)
时间窗: During the Study Conduct
Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L)
时间窗: during the study conduct
次要结局
- Maximum concentration (Cmax, μIU/mL)(During the study conduct)
- Area under the insulin concentration-time curve after injection(μIU.min/mL)(between 0 h and 1 h (AUC0-1h), 0 h and 1.5 h (AUC0-1.5h), 0 h and 2 h (AUC0-2h) and 0 h and 4 h (AUC0-4h))
- Adverse events collection(from the inform consnet signed up to the end of the study)
- Time to maximum concentration (Tmax, min)(During the study conduct)
研究者
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