NCT00365170已完成4 期
A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 96
- 主要终点
- Relative risk of major maternal hypoglycaemia
研究概览
简要总结
This trial was conducted in Europe, Middle East, North America and South America.
The aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Treated with insulin for at least 12 months
- •Either plan to become pregnant in the immediate future, willing to undertake pre pregnancy counselling, and has a screening HbA1c lesser than or equal to 12.0%, or
- •Pregnant with normal singleton pregnancy, gestational age for at least 10 weeks at the time of randomisation, confirmed by ultrasound scan.
排除标准
- •Previous birth of child with a major congenital malformation
- •More than 2 previous multiple miscarriages or stillbirths
- •Severe hyperemesis gravidarum, requiring hospitalisation, according to Investigator judgement
- •Subjects being treated for infertility
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Drug or alcohol abuse
- •Impaired renal, hepatic or cardiac function
结局指标
主要结局
Relative risk of major maternal hypoglycaemia
时间窗: after 24 hours
次要结局
- Other Adverse Events
- Diabetic complications
- Obstetric complications
- Relative risk of major and minor hypoglycaemia
研究者
研究点 (96)
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