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
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