The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Severe hypoglycaemia
研究概览
简要总结
Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia
详细描述
The primary objective is to evaluate the effects of insulin analogue and human insulin on incidence of severe hypoglycaemia in type 1 diabetic patients prone to hypoglycaemia.Secondary endpoints are effect on incidence of symptomatic and asymptomatic documented hypoglycaemia.
Study Design: An open, randomised, controlled, cross-over multi-centre study. Each treatment period lasts for one year. Patients will be randomised to treatment with basal bolus therapy with insulin detemir / aspart and insulatard / actrapid in random order. Endpoints will be assessed during the last 9 months of each treatment arm.
Patient population: 250 type 1 diabetic patients with a history of two or more episodes of severe hypoglycaemia during the preceding year.
Interventions: Basal bolus therapy with insulin detemir / aspart and insulatard / human actrapid in random order. Each treatment period lasts 12 months.
Methods: Patients will record all events of severe hypoglycaemia, documented symptomatic and asymptomatic hypoglycaemia in a diary and report all events of severe hypoglycaemia by telephone within 24 hours. All patients will be instructed to do and record home blood glucose monitoring (SMBG) i.e. 7 point profiles twice per week and nocturnal measurements once every month.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for 5 years.
- •Age>18 years.
- •Two or more episodes of hypoglycaemia during the last year,
排除标准
- •History of Addisons disease
- •Growth hormone deficiency or untreated myxoedema
- •CVD within 6 months
- •Cancer within 5 years
- •Alcohol or drug abuse
- •Pregnant or lactating women
- •Fertile women without effective contraception
- •Participation in another trial within 30 days
- •Inability to understand the informed consent
研究组 & 干预措施
1
HUman Insulin
干预措施: human insulin /insulin isophane (Drug)
2
Analogue insulin
干预措施: insulin levemir / aspart (Drug)
结局指标
主要结局
Severe hypoglycaemia
时间窗: 9 months
次要结局
- asymptomatic hypoglycaemia(9 months)
- hypoglycaemia during nighttime(9 months)
- hypoglycaemia during daytime(9 months)
研究者
Lise Tarnow
professor
Steno Diabetes Center Copenhagen