EUCTR2018-000393-29-FR进行中(未招募)1 期
Dulaglutide And Insulin MicrosecretiON in type I Diabetes - DIAMOND - DIAMOND
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 72
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
- 性别
- All
入选标准
- •Adult patients with T1D> 4years, with age range 20-60years
- •- Diabetes onset after the age of 15years
- •- Duration of diabetes <15 years
- •- Treated with continuous sub-cutaneous insulin infusions (CSI) or multiple daily injections of insulin (MDI)
- •- Measuring their blood sugar at least four times daily
- •- Glycated hemoglobin (HbA1C) at screening >7.5 and <9.5%
- •- BMI<30.0kg/m2
- •- Patients who gave its written informed consent to participate to the study
- •- Patients affiliated to a social insurance regime
- •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 72
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients with type 2 diabetes (T2D)
- •-Subjects with history of severe hypoglycemia or recent history of diabetic ketoacidosis
- •-History of gastrointestinal disease with prolonged nausea or vomiting, liver or kidney diseases, pancreatitis, thyroid medullary cancer or familial history of multiple endocrine neoplasia type 2
- •-Estimated glomerular filtration rate<60ml/min/ 1.73m2 (CKD-EPI method)
- •-Any uncontrolled disease
- •-Chronic use of drugs that directly affect GI mobility
- •-Chronic use of paracetamol containing products, which may falsely raise sensor glucose readings
研究者
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