No Evidence for Essential Differences Between the Effects of Insulin Glargine, Insulin Detemir and NPH Insulin on Glucose Metabolism After a Single Injection as Assessed by 24-h Euglycemic Clamp Studies in Healthy Humans
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.
研究概览
简要总结
To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection.
详细描述
In this randomized, double-blind, euglycemic glucose clamp study, 10 healthy male volunteers received a subcutaneous injection of 0.4 U/kg insulin detemir, insulin glargine or NPH insulin on three separate study days in a cross-over design. After insulin administration, plasma glucose was maintained at 0.3 mmol/l below fasting level for 24 hours by manually adjusted glucose infusion. C-peptide, insulin, NEFA and counter regulatory hormones were measured throughout the clamp period. Endogenous glucose release (EGR) was assessed by the isotope dilution technique (3-3H-glucose).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI 20 - 50 kg/m2
- •Blood pressure < 140/90 mmHg
- •signed informed consent
- •Caucasien
排除标准
- •Diabetes or other disease
- •Alcohol or drug abuse
- •Use of prescription drugs
研究组 & 干预措施
1
Insulin detemir
干预措施: Insulin detemir (Drug)
2
Insulin glargine
干预措施: Insulin glargine (Drug)
3
NPH insulin
干预措施: Insulatard (Drug)
结局指标
主要结局
Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.
时间窗: 24 hours
次要结局
未报告次要终点
