跳至主要内容
临床试验/EUCTR2013-001003-36-AT
EUCTR2013-001003-36-AT进行中(未招募)1 期

The DIAMOND for the Treatment of Type 2 Diabetes: Can Blood Triglycerides level be the predictor for therapy efficiency?

Metacure Ltd.0 个研究点目标入组 45 人开始时间: 2014年5月20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)
发起方
入组人数
45

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

  • Male and female subjects 18 through 70 years of age
  • Body mass index > 30 and < 45 (kg/m2)
  • Type 2 diabetes duration of at least 6 months
  • Type 2 diabetic subjects treated with oral anti-diabetic agents [Sulfonylurea, Metformin, thiazolinedione (TZD) or DPP-4 inhibitors]
  • Stable anti-diabetic medications for at least 3 months prior to enrollment, six months for thiazolinedione (TZD)
  • The subject has been under routine diabetes care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment
  • HbA1c ?7.3% and = 9.5 % on Visit 1
  • Stable HbA1c, defined as no significant change (variation = 0.5%) between a historical value recorded in the subject’s medical record within 3 months prior to enrollment and the HbA1c gathered on Visit 1.
  • Fasting blood glucose >120 and < 350 mg/dl on Visit 1.
  • 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 45
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Insulin therapy in last 3 months
  • Taking GLP-1 agonists or in the last 3 months before the enrollment
  • Currently taking fibrates, nicotinamide and omega 3 fatty acids as antilipidemic treatment

研究者

发起方
Metacure Ltd.

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