NCT00184613已完成1 期
An Open-label, Randomised, In-patient, Cross Over PK/PD Trial Investigating the Pharmackinectic and Pharmacodynamic Profiles Following Continuous Subcutaneous Infusion of Insulin Aspart or Injection of Insulin Glargine in Subjects With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Variation in morning FPG
研究概览
简要总结
This trial is conducted in Europe. The objective of the study is to investigate the effect and safety of continously basal delivered insulin aspart given by a pump versus once daily injection of insulin glargine.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 diabetes for more than 2 years
- •Subjects currently treated with unchanged insulin glargine dose (10 -100 units) for 2 weeks
- •Subjects currently treated with unchanged dose(s) for at least 1 month on one or two Oral Anti-diabetic drugs
- •BMI 25 - 40 kg/m2
- •HbA1c < 9.5 %
排除标准
- •Known or suspected allergy to trial product(s) or related products
- •Previous randomisation in this trial
- •Pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women judged not to be using adequate contraceptive measures (Only sterilisation, intra uterine devices and contraceptive pills are considered adequate contraceptive methods)
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation.
- •Any other significant illness such as endocrine, cardiac, neurological, malignant or other pancreatic illness judged by Investigator
- •Participation in other studies within the last three months
结局指标
主要结局
Variation in morning FPG
时间窗: Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge
次要结局
- Variation of plasma endogenous insulin and insulin aspart/glargine collected in hospital on the last 5 days and the morning on discharged
- Variation of pre-dinner plasma glucose collected in hospital on the last 3 days
研究者
研究点 (2)
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