NCT00490893终止4 期
Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Hormone response to hypoglycemia (Glucagon)
研究概览
简要总结
Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and physicochemical properties which differ from human insulin. The aim of the present study is to test whether this leads to altered hormone and symptom response during hypoglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects male or female
- •Age 18-50 years
- •Female subjects save contraception
- •Ability to take part in the study
- •Signed consent
排除标准
- •Chronic disease
- •Acute disease during 4 weeks prior to the study
- •Pregnancy
- •Drug treatment other than hormonal contraception
结局指标
主要结局
Hormone response to hypoglycemia (Glucagon)
Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia
次要结局
- Hormone response to glucagon (epinephrine, growth hormne, cortisol)
- Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia
研究者
研究点 (2)
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