EUCTR2005-004754-27-GB进行中（未招募）1 期
Comparison of insulin detemir and insulin glargine in patients with Type 2 diabetes - Detemir vs Glargine
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
- 12
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
- •Type 2 diabetes (GAD negative) not currently treated with insulin
- •Male or female
- •Age 18-75 years inclusive
- •HbA1c =7.0 = 11.0 % inclusive
- •BMI =35 kg/m2
- •Written, signed, 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Diabetes other than type 2 diabetes mellitus
- •Type 2 diabetic patients requiring insulin treatment
- •Patients with severe complication of diabetes e.g. pre-proliferative or proliferative retinopathy; diabetic nephropathy (serum creatinine > 160 micromol/L); ischemic heart disease with clinically significant angina pectoris
- •Evidence of hepatic disease as determined by AST and/or ALT values of greater than 2 X upper level of normal
- •History of drug or alcohol abuse within the last 5 years
- •History of multiple drug allergies
- •Participation in any investigational drug trial within 3 months prior to Visit 1
- •History of non-compliance to medical regimens or those patients who are unwilling or unable to comply with the trial protocol
- •Pregnancy or planning to become pregnant during the trial
- •Patients who are taking corticosteroids, thyroxine or growth hormones.
研究者
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