NCT01697657已完成3 期
A Randomised, Open Label, Cross-over, Multi-centre, Multinational Trial Comparing the Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir and NPH Insulin in Well Controlled Subjects With Type 1 Diabetes on a Basal-bolus Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Incidence of total self-recorded hypoglycaemic episodes
研究概览
简要总结
This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to NPH insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control subjects with type 1 diabetes.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Fasting c-peptide below lower limit of normal fasting range
- •Duration of type 1 diabetes for at least 12 months
- •Current treatment: Basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections
- •HbA1c maximum 9.0% (using Biorad Variant method)
- •Able and willing to perform self-monitoring of blood glucose
- •Basal insulin requirement at least 30% of the total daily insulin dose
- •BMI (body Mass Index) maximum 35 kg/m^2
排除标准
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Total daily insulin dose above 1.4 IU/kg/day
- •Known unawareness of hypoglycaemia
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac problems
- •Uncontrolled, treated/untreated hypertension
- •Known or suspected allergy to trial product or related products
研究组 & 干预措施
Detemir
Experimental
干预措施: insulin detemir (Drug)
Detemir
Experimental
干预措施: insulin aspart (Drug)
NPH
Active Comparator
干预措施: insulin NPH (Drug)
NPH
Active Comparator
干预措施: insulin aspart (Drug)
结局指标
主要结局
Incidence of total self-recorded hypoglycaemic episodes
次要结局
- Serum glucose profiles
- Within-subject variation in home-measured fasting plasma glucose
- 72-hours glucose profile
- Incidence of adverse events
- Incidence of total major hypoglycaemic episodes
- HbA1c (glycosylated haemoglobin)
- 8-point plasma glucose profiles
研究者
研究点 (1)
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