EUCTR2018-004680-31-DK进行中（未招募）1 期
A randomised controlled trial comparing the effect of the faster-acting insulin analog - insulin Fiasp® – versus insulin Novorapid® in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation
ene Ringholm0 个研究点目标入组 220 人开始时间: 2019年4月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Women, age = 18 years
- •Duration of type 1 diabetes = 12 months or type 2 diabetes (any duration)
- •Pregnant with an intrauterine singleton living fetus (5 to 13 completed gestational weeks) at inclusion confirmed by an ultrasound scan
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 220
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A diagnosis with severe mental or psychiatric barriers or a concurrent disease on the decision of the principal investigator
- •Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin glargine, insulin abasaglar, insulin toujeo or NPH insulin and not willing to continue routine treatment modality
- •Women with type 2 diabetes who before pregnancy were either treated with diet, oral antidiabetic therapy or pre-mixed insulin who are not willing to change to trial medication according to randomisation or to an appropriate long-acting insulin analog as insulin detemir, insulin degludec, insulin glargine, insulin abasaglar or insulin toujeo (as part of routine MDI therapy in type 2 diabetes), as indicated.
- •No proficiency in Danish to understand oral and written information
研究者
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