NCT00145353Unknown4 期
Is Insulin NovoRapid Better Than Actrapid for Treating Type 1 Diabetic Patients When Simultaneously, Daily Adjusting the Insulin Dose?
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Meal-regulated insulin time two peaks after the two intervention periods
研究概览
简要总结
The main purpose of the study is to investigate the reason for the reduced number of hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin Aspart at meals together with NPH insulin mornings and evenings, and when, in another period of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and when the patients in both periods simultaneously take extra insulin at meals if high blood glucose values are found before meals.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening.
- •AGe: 18-60 years
- •BMI: 18-27.5
- •No nefro- or neuropathy; i.e. S-creatinin below 120 μmol/l and normal monofilament examination
- •Written informed consent
排除标准
- •Pregnant women or patients planning to become pregnant during the investigation period
- •Reduced eyesight; i.e. visus > 0.3 evaluated at the latest eye exam.
- •Patient lacking the ability to sens insulin sensitivity
- •Serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease.
- •Suspicion of abuse or non-compliance
- •Participation in another clinical trial
结局指标
主要结局
Meal-regulated insulin time two peaks after the two intervention periods
次要结局
未报告次要终点
研究者
研究点 (2)
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