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临床试验/EUCTR2018-000393-29-FR
EUCTR2018-000393-29-FR进行中(未招募)1 期

Dulaglutide And Insulin MicrosecretiON in type I Diabetes - DIAMOND - DIAMOND

Hospices Civils de Lyon0 个研究点目标入组 72 人开始时间: 2018年4月4日最近更新:
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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