EUCTR2016-001401-16-NL进行中（未招募）1 期
The SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy - SUGAR-DIP
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 810
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
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •- Aged 18 years or over
- •- Singleton pregnancy
- •- Diagnosis of GDM as per national guidelines
- •- Indication for pharmacological treatment of GDM
- •- Gestational age between 16 and 34 weeks
- •- Ability to understand Dutch or English
- •- Ability to provide written informed consent
- •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 810
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who meet any of the following criteria will be excluded from the study:
- •- Known pre-existent type 1 or type 2 diabetes mellitus
- •- Severe medical or psychiatric comorbidities
- •- Serious liver disease or kidney failure, or any other condition with contraindications for the use of either metformin or glibenclamide
- •- Pregnancy with a fetus affected by major congenital birth defects and/or chromosomal abnormalities
研究者
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